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EC number: 202-635-0 | CAS number: 98-08-8
- 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
Skin Irritation
Based on the results of an OECD 404 study the test item is not requiring classification for skin irritation (UN GHS: No Category) (reference 7.3.1-1).
Eye Irritation
Based on the results of an OECD 405 study the test item is not requiring classification for eye damaging potential (UN GHS: No Category) (reference 7.3.2-1).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.8 - 3.1 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Amount / concentration applied:
- - Amount(s) applied: 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 2 weeks
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Skin of back and sides.
SCORING SYSTEM:
The findings at test sites were evaluated 30 and 60 min after the end of exposure and after 24, 48 and 72 hours. The findings were expressed numerically in accordance with the Draize scheme. - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: eschar score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritant / corrosive response data:
- Areas of very mild edema and mild to moderate erythema were observed in all rabbits up to 72 hours after application. While the erythema and edema had almost completely disappeared by the end of the observation period, the skin surface remained dry and rough, and was parchment-like and flaky in parts. Scab formation was seen in 1 animal after 7 days. The average irritation value was 2.0 for erythema and eschar formation and 0.2 for edema formation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is considered to be not irritating to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated by topical application of 0.5 mL to skin of the back and sides of each of three young adult New Zealand White rabbits in an OECD 404 study. The duration of treatment was four hours. The scoring of skin reactions was performed 0.5, 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. Areas of very mild edema and mild to moderate erythema were observed in all rabbits up to 72 hours after application. While the erythema and edema had almost completely disappeared by the end of the observation period, the skin surface remained dry and rough, and was parchment-like and flaky in parts. Scab formation was seen in 1 animal after 7 days. The average irritation value was 2.0 for erythema and eschar formation and 0.2 for edema formation. The test item was accordingly assessed as a mild skin irritant in rabbits. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based upon the above results, the test item is considered to be not irritating to rabbit skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.6 - 3.1 kg - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- - Amount(s) applied: 0.1 mL
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: washed with physiological saline
- Time after start of exposure: 24 hrs after exposure
SCORING SYSTEM:
The effects were evaluated in accordance with the Draize scheme, 1, 24, 48 and 72 hours after instillation. - Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- One hour after instillation, the vessels were clearly injected and the conjunctivae were carmine-coloured and slightly swollen. At all other examination times, the eyes appeared normal. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was evaluated as not irritating to the eye.
- Executive summary:
The primary irritation potential of the test item was investigated by instillation of 0.1 mL into one eye of each of three young adult New Zealand White rabbits in an OECD 405 study. The treated eyes were rinsed gently with physiological saline solution approximately 24 hours after administration. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. One hour after instillation, the vessels were clearly injected and the conjunctivae were carmine-coloured and slightly swollen. At all other examination times, the eyes appeared normal. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. Based upon the above results, the test item is considered to not be severely irritating to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
The primary skin irritation potential of the test item was investigated by topical application of 0.5 mL to skin of the back and sides of each of three young adult New Zealand White rabbits in an OECD 404 study (reference 7.3.1-1). The duration of treatment was four hours. The scoring of skin reactions was performed 0.5, 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. Areas of very mild edema and mild to moderate erythema were observed in all rabbits up to 72 hours after application. While the erythema and edema had almost completely disappeared by the end of the observation period, the skin surface remained dry and rough, and was parchment-like and flaky in parts. Scab formation was seen in 1 animal after 7 days. The average irritation value was 2.0 for erythema and eschar formation and 0.2 for edema formation. The test item was accordingly assessed as a mild skin irritant in rabbits. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based upon the above results, the test item is considered to be not irritating to rabbit skin.
Eye Irritation
The primary irritation potential of the test item was investigated by instillation of 0.1 mL into one eye of each of three young adult New Zealand White rabbits in an OECD 405 study (reference 7.3.2-1). The treated eyes were rinsed gently with physiological saline solution approximately 24 hours after administration. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. One hour after instillation, the vessels were clearly injected and the conjunctivae were carmine-coloured and slightly swollen. At all other examination times, the eyes appeared normal. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. Based upon the above results, the test item is considered to not be severely irritating to the eye.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is not considered to be classified for skin irritation and for eye damaging potential under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EC) No 2019/521.
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