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Open for public comment: 17 chemical evaluations and 3 calls for information on hazard and use of chemicals. Closes 25 June 2021.

Data waivers available in IUCLID

Description of data waivers available in IUCLID6 (version 5.1.2)

When you apply for an assessment certificate in AICIS Business Services, there may be circumstances where you cannot provide test data, or it is infeasible to provide test data for certain physical and chemical properties, environment and human health-related end points. In these situations, you can apply data waivers available in IUCLID6 (version 5.1.2).

Standard data waiver options for a property or an end point in IUCLID6 typically would include:

  • study technically not feasible
  • study scientifically not necessary / other information available
  • exposure considerations
  • study waived due to provisions of other regulation
  • other justification

Below are the commonly used data waivers available in IUCLID. If none of these apply, then you can select “other justification” from the drop list which will enable the free text box for you to enter your own justification. 

Physical and chemical properties

Boiling point

Study technically not feasible:

  • the study does not need to be conducted for explosives 
  • the study does not need to be conducted for self-reactive substances 
  • the study does not need to be conducted because chemical change occurred during the melting point study 

Study scientifically not necessary / other information available: 

  • the study does not need to be conducted because the substance is a gas and the transition from liquid to gas, if any, does not occur close to 20°C 
  • the study does not need to be conducted because the substance is a solid which melts above 300°C 
  • the study does not need to be conducted because the substance is a solid which decomposes before boiling

Density

Study scientifically not necessary / other information available: 

  • the study does not need to be conducted because the substance is only stable in solution in a particular solvent and the solution density is similar to that of the solvent

Particle size distribution (Granulometry)

Study scientifically not necessary / other information available: 

  • the study does not need to be conducted because the substance is marketed or used in a non solid or granular form

Vapour pressure

Study technically not feasible: 

  • vapour pressure testing is not required because the standard boiling point is <30ºC (less than 30 degrees Celsius), as this substance will have a vapour pressure value above the limit of measurement (i.e. 10E+05 Pa)
  • the study does not need to be conducted for explosives
  • the study does not need to be conducted because the substance is self-reactive
  • the study does not need to be conducted for organic peroxides

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the melting point is above 300ºC

Partition coefficient

Study technically not feasible:

  • the study does not need to be conducted because the substance is inorganic 
  • the study does not need to be conducted because the substance decomposes
  • the study does not need to be conducted because the substance has a high surface activity
  • the study does not need to be conducted because the substance reacts violently during the performance of the test 
  • the study does not need to be conducted because the substance does not dissolve in water or in octanol

Water solubility

Study scientifically not necessary / other information available: 

  • the study does not need to be conducted because the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours) 
  • the study does not need to be conducted because the substance is readily oxidisable in water

Flash point

Study technically not feasible:

  • the study does not need to be conducted because the substance is a gas 
  • the study does not need to be conducted because the substance is an aerosol 
  • the study does not need to be conducted because the substance is inorganic
  • the study does not need to be conducted because the substance is an inorganic liquid with no covalent bonds
  • the study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids
  • the study does not need to be conducted because the substance only contains volatile organic components with flash-points above 100ºC for aqueous solutions
  • the study does not need to be conducted for explosives
  • the study does not need to be conducted because the substance is pyrophoric
  • the study does not need to be conducted because decomposition occurred during the melting point study
  • the study does not need to be conducted because some impurities have an impact on the ignition source in such a way as to distort/invalidate the results

Study scientifically not necessary / other information available:

  • the study does not need to be conducted — the flash point for liquid organic peroxides is only relevant in the temperature range where the product is thermally stable. Above the SADT (self-accelerating decomposition temperature) of the product flash point determination is not relevant because decomposition products are evolved 
  • the study does not need to be conducted — the flash point for liquid self-reactive substances is only relevant in the temperature range where the product is thermally stable. Above the SADT (self-accelerating decomposition temperature) of the product flash point determination is not relevant because decomposition products are evolved

Auto flammability

Study technically not feasible: 

  • the study does not need to be conducted for explosives
  • the study does not need to be conducted because the substance is pyrophoric 
  • the study does not need to be conducted for liquid organic peroxides — the vapours decompose during the execution of the test 
  • the study does not need to be conducted for liquid self-reactive substances — the vapours decompose during the execution of the test

Study scientifically not necessary / other information available:

  • the study does not need to be conducted — the substance is a liquid non flammable in air, for example, no flash point up to 200ºC 
  • the study does not need to be conducted — the substance is a gas having no flammable range
  • the study does not need to be conducted — the substance is a solid having a melting point <=160ºC (less than or equal to 160 degrees Celsius)

Flammability

Study technically not feasible:

  • the study does not need to be conducted for explosives 
  • the study does not need to be conducted because the substance is pyrophoric 
  • the study does not need to be conducted for organic peroxides
  • the study does not need to be conducted for self-reactive substances
  • the study does not need to be conducted because the substance is a solid
  • the study does not need to be conducted because the substance is a liquid
  • the study does not need to be conducted because the substance is no aerosol
  • the study does not need to be conducted for self-reactive substances / mixtures
  • the study does not need to be conducted because the substance is a gas

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is a gas and the concentration of the flammable gas in a mixture with inert gases is so low that, when mixed with air, the concentration is all time below the lower limit
  • the study does not need to be conducted because the substance is known to be stable in contact with air at room temperature for prolonged periods of time (days) and hence, the classification procedure does not need to be applied 
  • the study does not need to be conducted because the substance is completely molten at 160ºC
  • the study does not need to be conducted because the substance undergoes exothermic decomposition at a temperature below or equal to 140ºC 
  • the study does not need to be conducted because the organic substance does not contain metals or metalloids and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the experience in production or handling shows that the substance does not react with water, for example, the substance is manufactured with water or washed with water
  • the study does not need to be conducted because the substance is known to be soluble in water to form a stable mixture

Other justification:

  • the study does not need to be conducted because the substance is an aerosol and aerosols shall not be classified as flammable gases 
  • the study does not need to be conducted because the aerosol is not submitted to the flammability classification procedures, but is classified as 'extremely flammable' (Aerosol, Category 1)

Explosiveness

Study technically not feasible:

  • the study does not need to be conducted because the substance is a gas 

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because there are no chemical groups present in the molecule which are associated with explosive properties 
  • the study does not need to be conducted because the substance contains chemical groups associated with explosive properties which include oxygen, but the calculated oxygen balance is less than – 200
  • the study does not need to be conducted because the substance is an organic substance or mixture containing chemical groups associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500°C

Oxidising properties

Study technically not feasible:

  • the study does not need to be conducted for explosives
  • the study does not need to be conducted for flammable aerosols
  • the study does not need to be conducted for organic peroxides
  • the study does not need to be conducted because the substance is a solid
  • the study does not need to be conducted because the substance is a liquid
  • the study does not need to be conducted because the substance is a gas

Study scientifically not necessary / other information available:

  • the study does not need to be conducted for flammable gases
  • the study does not need to be conducted because there are no chemical groups present in the molecule which are associated with oxidising properties and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the substance is pyrophoric
  • the study does not need to be conducted because the organic substance does not contain oxygen or halogen atoms and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the organic substance contains oxygen or halogen atoms which are chemically bonded only to carbon or hydrogen and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the inorganic substance does not contain any oxygen or halogen atoms and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the substance is incapable of reacting exothermically with combustible materials
  • the study does not need to be conducted because the substance is flammable

Dissociation constant

Study technically not feasible:

  • the study does not need to be conducted because the analytical method is not sensitive enough
  • the study does not need to be conducted because the substance has no ionic structure
  • the study does not need to be conducted because the substance is insoluble

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is hydrolytically unstable (half-life less than 12 hours)
  • the study does not need to be conducted because the substance is readily oxidisable in water

Hydrolysis

Study technically not feasible:

  • the study does not need to be conducted because the substance is highly insoluble in water

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is readily biodegradable

Adsorption / Desorption

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance has a low octanol water partition coefficient and the adsorption potential of this substance is related to this parameter 
  • the study does not need to be conducted because the physicochemical properties of the substance indicate that it can be expected to have a low potential for adsorption 
  • the study does not need to be conducted because the substance and its relevant degradation products decompose rapidly

Environment-related end points

Biodegradation in water — screening tests

Study technically not feasible:

  • the study does not need to be conducted because the substance is inorganic

Bioaccumulation — aquatic / sediment

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance has a low potential for bioaccumulation based on log Kow <= 3 (log Kow is less than or equal to 3) and a low potential to cross biological membranes 
  • the study does not need to be conducted because the substance has a low potential for bioaccumulation based on log Kow <= 3 (log Kow is less than or equal to 3) 
  • the study does not need to be conducted because the substance has a low potential to cross biological membranes

Exposure consideration:

  • the study does not need to be conducted because direct and indirect exposure of the aquatic compartment to the substance is unlikely

Short-term toxicity to fish

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur 
  • the study does not need to be conducted because the substance is unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur
  • the study does not need to be conducted because a long-term aquatic toxicity study on fish is available
  • the study does not need to be conducted because a long-term aquatic toxicity study on fish is proposed to be conducted

Short-term toxicity to aquatic invertebrates

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
  • the study does not need to be conducted because the substance is unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur
  • the study does not need to be conducted because a long-term aquatic toxicity study on invertebrates is available
  • the study does not need to be conducted because a long-term aquatic toxicity study on invertebrates is proposed to be conducted

Human health-related end points

Acute toxicity — oral

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is classified as corrosive to the skin
  • the study does not need to be conducted because a study on acute toxicity by the inhalation route is available

Acute toxicity — inhalation

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is classified as corrosive to the skin

Exposure considerations:

  • the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Acute toxicity — dermal

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is classified as corrosive to the skin 
  • the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin 
  • the study does not need to be conducted because inhalation of the substance is likely 
  • the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (for example, skin irritation, skin sensitisation) 
  • the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (for example, read across, QSAR studies)

Exposure considerations; study scientifically not necessary / other information available:

  • the study does not need to be conducted because skin contact in production and/or use is not likely

Skin irritation / corrosion

Study technically not feasible:

  • the study does not need to be conducted because the substance is spontaneously flammable in air or in contact with water or moisture at room temperature

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is classified as acute toxicity by the dermal route (Category 1) 
  • the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2000 mg/kg body weight)
  • the study does not need to be conducted because the substance is a strong acid (pH ≤ 2.0, meaning pH is less than or equal to 2.0), or base (pH ≥ 11.5, meaning pH is greater than or equal to 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C)
  • an in vitro skin irritation study does not need to be conducted because the available in vitro test methods are not applicable for the substance and therefore, an in vivo skin irritation study was conducted
  • an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Eye irritation

Study technically not feasible:

  • the study does not need to be conducted because the substance is spontaneously flammable in air or in contact with water or moisture at room temperature

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2) 
  • the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
  • the study does not need to be conducted because the substance is a strong acid (pH <= 2.0, meaning pH is less than or equal to 2.0) or base (pH => 11.5, meaning pH is greater than or equal to 11.5) and the available information indicates that it should be classified as serious eye damage (Category 1)
  • an in vitro eye irritation study does not need to be conducted because the available in vitro test methods are not applicable for the substance and therefore an in vivo eye irritation study was conducted
  • an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Skin sensitisation

Study technically not feasible:

  • the study does not need to be conducted because the substance is spontaneously flammable in air or in contact with water or moisture at room temperature

Study scientifically not necessary / other information available:

  • the study does not need to be conducted because the substance is a strong acid (pH ≤2.0, meaning pH is less than or equal to 2.0) or base (pH =>11.5, meaning pH is greater than or equal to 11.5) 
  • the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C) 
  • an in vitro skin sensitisation study does not need to be conducted because the available in vitro test methods are not applicable for the substance and therefore an in vivo skin sensitisation study was conducted
  • an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Repeated dose toxicity — oral

Study scientifically not necessary / other information available:

  • a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
  • a short-term toxicity study does not need to be conducted because a sub-chronic (90 days) or chronic toxicity study is proposed to be conducted with an appropriate species, dosage, solvent and route of administration
  • a sub-chronic toxicity study (90 days) does not need to be conducted because a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the relevant criteria for classifying the substance, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure
  • a sub-chronic toxicity study (90 days) does not need to be conducted because a reliable chronic toxicity study is available, conducted with an appropriate species and route of administration 

Exposure considerations; study scientifically not necessary / other information available:

  • a short-term toxicity study by the oral route does not need to be conducted — an appropriate inhalation study is available and inhalation is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment 
  • a short-term toxicity study by the oral route does not need to be conducted — an appropriate dermal study is available and dermal is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment 
  • a sub-chronic toxicity study (90 days) by the oral route does not need to be conducted — an appropriate dermal study is available and dermal is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment
  • a sub-chronic toxicity study (90 days) does not need to be conducted — the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day 'limit test' and human exposure is limited
  • a sub-chronic toxicity study (90 days) by the oral route does not need to be conducted — an appropriate inhalation study is available and inhalation is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment

Exposure considerations:

  • a short-term toxicity study does not need to be conducted — relevant human exposure can be excluded as based on the provided thorough and rigorous exposure assessment

Repeated dose toxicity — inhalation

Study scientifically not necessary / other information available:

  • a short-term toxicity study does not need to be conducted — a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
  • a short-term toxicity study does not need to be conducted — a sub-chronic (90 days) or chronic toxicity study is proposed to be conducted with an appropriate species, dosage, solvent and route of administration
  • a sub-chronic toxicity study (90 days) does not need to be conducted — a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the relevant criteria for classifying the substance, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure
  • a sub-chronic toxicity study (90 days) does not need to be conducted— a reliable chronic toxicity study is available, conducted with an appropriate species and route of administration

Exposure considerations; study scientifically not necessary / other information available:

  • a sub-chronic toxicity study (90 days) does not need to be conducted because the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day 'limit test' and human exposure is limited

Exposure considerations:

  • a short-term toxicity study does not need to be conducted — exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Repeated dose toxicity — dermal

Study scientifically not necessary / other information available:

  • a short-term toxicity study does not need to be conducted — a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
  • a short-term toxicity study does not need to be conducted — a sub-chronic (90 days) or chronic toxicity study is proposed to be conducted with an appropriate species, dosage, solvent and route of administration
  • a sub-chronic toxicity study (90 days) does not need to be conducted — a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the relevant criteria for classifying the substance, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure
  • a sub-chronic toxicity study (90 days) does not need to be conducted — a reliable chronic toxicity study is available, conducted with an appropriate species and route of administration

Exposure considerations; study scientifically not necessary / other information available:

  • a sub-chronic toxicity study (90 days) does not need to be conducted — the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day 'limit test' and human exposure is limited

Exposure considerations:

  • a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Genetic toxicity in vitro

Study scientifically not necessary / other information available

  • an in vitro cytogenicity study in mammalian cells or in vitro micronucleus study does not need to be conducted because adequate data from an in vivo cytogenicity test are available
  • an in vitro cytogenicity study in mammalian cells or in vitro micronucleus study does not need to be conducted because the substance is known to be carcinogenic category 1A or 1B or germ cell mutagenic category 1A, 1B or 2
  • an in vitro gene mutation study in mammalian cells does not need to be conducted because adequate data from a reliable in vivo mammalian gene mutation test are available
  • an in vitro gene mutation study in mammalian cells does not need to be conducted because a positive result was found in in vitro gene mutation study in bacteria
  • an in vitro gene mutation study in mammalian cells does not need to be conducted because a positive result was found in in vitro cytogenicity study in mammalian cell
  • an in vitro gene mutation study in mammalian cells does not need to be conducted because a positive result was found in in vitro micronucleus study
     
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