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Diss Factsheets
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EC number: 201-612-2 | CAS number: 85-52-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Studies performed under GLP conditions.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test item was applied as supplied
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16 mg
- Duration of treatment / exposure:
- 42 min
- Duration of post-treatment incubation (if applicable):
- 42h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test item - Mean percent viability
- Value:
- 89.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test item - Run 1
- Value:
- 100.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test item - Run 2
- Value:
- 89
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test item - Run 3
- Value:
- 78
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Negative control - Mean percent viability
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Positive control - Mean percent viability
- Value:
- 1.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin irritation potential was tested according to OECD 439 guideline on reconstructed human epidermis. The mean percent viability of the treated tissues was 89.1%. In accordance with the regulation EC n°1272/2008, the test item has to be considered as non-irritant to skin. It corresponds to UN GHS No category.
- Executive summary:
The skin irritation potential was tested according to OECD 439 guideline on reconstructed human epidermis. The mean percent viability of the treated tissues was 89.1%. In accordance with the regulation EC n°1272/2008, the test item has to be considered as non-irritant to skin. It corresponds to UN GHS No category.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- chicken
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg of test item after being reduced in fine powder
- Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- Treated corneas were evaluated pretreatment and starting at 30, 75, 120, 180 and 240 min after post-treatment rinse.
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Maximal mean
- Value:
- 2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: corresponding to ICE class III
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Mean
- Value:
- 3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: correspondaing ti ICE class IV
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Maximal mean
- Value:
- 4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: corresponding to ICE class I
- Other effects / acceptance of results:
- The combinaison of the three endpoints for the positive control was 3 x IV. Therefore, the positive control is classified as "corrosive / severe irritant", as expected.
The combinaison of the three endpoints for the negative control was 3 x I. Therefore, the positive control is classified as "No category", as expected. - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The eye irritation potential of the test item was determined according to OECD 438 guideline on isolated chicken eye. The results obtained show that the combination of the three endpoints for the test item was 1 x IV, 1 x III, 1 x I. This combination leads to the category "No prediction can be made" as defined in the OCED guideline. Additional testing is required to establish a definitive classification.
- Executive summary:
The eye irritation potential of the test item was determined according to OECD 438 guideline on isolated chicken eye. The results obtained show that the combination of the three endpoints for the test item was 1 x IV, 1 x III, 1 x I. This combination leads to the category "No prediction can be made" as defined in the OCED guideline. Additional testing is required to establish a definitive classification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The skin irritation potential was tested according to OECD 439 guideline on reconstructed human epidermis. The mean percent viability of the treated tissues was 89.1%. In accordance with the regulation EC n°1272/2008, the test item has to be considered as non-irritant to skin. It corresponds to UN GHS No category.
The eye irritation potential of the test item was determined according to OECD 438 guideline on isolated chicken eye. The results obtained show that the combinaison of the three endpoints for the test item was 1 x IV, 1 x III, 1 x I. This combinaison lead to the category "No prediction can be made" as defined in the OCDE guideline. Additionnal testing is required to establish a definitive classification.
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