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EC number: 208-534-8 | CAS number: 532-32-1
- 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/corrosion
1) A primary skin irritation study (Daamen, 1989) is available which is key study. This study showed that the test substance is not irritating.
2) An abstract (Loeser, 1977) is available which demonstrated the test substance is not irritating.
Eye irritation
1) An acute eye irritation study (Daamen, 1989) is available which is key study. This study showed that the test substance is sufficiently irritating to warrant classification as Category 2 (Reversible eye effects).
2) Another abstract (Loeser, 1977) is available which demonstrated the test substance is not irritating.
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:
- From 03 to 06 May 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, West-Germany
- Age at study initiation: ±12 weeks
- Weight at study initiation: 2462-3094 gram
- Housing: Individually in cages with perforated floors equipped with an automatic drinking system
- Diet (e.g. ad libitum): Standard laboratory rabbit diet approx. 100 gram per day
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water
- Acclimation period: At least five days under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3℃
- Humidity (%): 30-70%
- Air changes (per hr): 7.5-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/ 12 hours dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 100 square centimeters (10 cm×10 cm)
- % coverage:
- Type of wrap if used: elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: One of three animals appeared very slight erythema.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The test substance resulted in a primary irritation index of 0 (non-irritation) when applied to intact rabbit skin.
The observed skin irritation consisted of very slight erythema in one animal. The irritation was reversible within 24 hours after exposure.
No corrosive effect was evident on the skin. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not irritating when applied to the intact rabbit skin.
- Executive summary:
This study was conducted under GLP according to OECD 404. Three rabbits were exposed to 0.5 g of the test substance, moistened with water, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed at 1, 24, 48 and 72 hours after the removal of the dressings and test article.
Under the conditions of this study, the test substance resulted in a primary irritation index of 0 when applied to the intact rabbit skin. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. In conclusion, the test substance is not irritating when applied to the intact rabbit skin.
The study represents a worst case situation as the treated skin area was 100 cm2 instead of 6 cm2 as required by the present version of OECD 404.
Reference
Individual skin irritation scores
Time after exposure |
Rabbit 2735 |
Rabbit 2736 |
Rabbit 2737 |
|||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
0 0 0 0 |
1 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
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:
- From 10 to 24 May 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Animal 2711 from Broekman Institute, Someren, The Netherlands. Animals 2717 and 2737 from Charles River Wiga, Sulzfeld, West-Germany.
- Age at study initiation: Approx. 12-14 weeks
- Weight at study initiation: 2654-3179 grams
- Housing: Individually in cages with perforated floors and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): Pelleted standard rabbit maintenance diet approx. 100 g per day.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water.
- Acclimation period: At least five days under test conditions for animal 2711, four days for animal 2737 and two days for animal 2717.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3℃
- Humidity (%): 30-83%
- Air changes (per hr): 7.5-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light / 12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ±60 mg - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Draize scale - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- The test substance appeared to be mildly irritating (M2) to the rabbit eye (Kay and Calandra interpretation of the Draize score: 9.3).
Instillation of the substance into one of the eyes of each of three albino rabbits affected the conjunctivae. The irritation of the conjunctivae was reversible within 14 days.
Treatment of the eyes with fluorescein 2%, 24 hours after test article instillation revealed no corneal epithelial damage in any of the animals.
No corrosion was observed. - Other effects:
- No staining by the test article was observed.
No toxic symptoms were observed in the animals during the test period and no mortality occurred. - Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is mildly irritating to the rabbit eye, sufficient to warrant classification as Category 2 (Reversible eye effects).
- Executive summary:
This study was conducted under GLP according to OECD 405. Three rabbits were exposed to 60 mg of the test substance, by instilling the test substance into the eye. The eyes of each animal were examined approx. 1, 24 ,48 and 72 hours, and 7 and 14 days after instillation of the test article.
Under the conditions of this study, the test substance resulted in adverse effects on the conjunctivae. The irritation of the conjunctivae was reversible within 14 days. No corrosion nor signs of systemic intoxication were observed. The test article should be considered mildly irritating to the rabbit eye.
Reference
Individual eye irritation scores
Animal |
Time after application |
Cornea opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
||||
2711 |
1 hour 24 hours 48 hours 72 hours 7 days 14 days |
0 0 0 0 0 0 |
1 0 0 0 0 0 |
1 2 3 3 2 0 |
1 1 1 0 0 0 |
2717 |
1 hour 24 hours 48 hours 72 hours 7 days 14 days |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
2 2 3 3 2 0 |
2 1 1 0 0 0 |
2737 |
1 hour 24 hours 48 hours 72 hours 7 days 14 days |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
1 2 2 2 1 0 |
1 1 1 0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation/corrosion
1) A primary skin irritation study was conducted according to OECD 404 using rabbits (Daamen, 1989). Key study.
This study showed that the test substance is not irritating.
2) An abstract (Loeser, 1977) is available which demonstrated the test substance is not irritating.
Eye irritation
1) An acute eye irritation study was conducted according to OECD 405 using rabbits (Daamen, 1989). Key study.
This study showed that the test substance is sufficiently irritating to warrant classification as Category 2 (Reversible eye effects)
2) Another abstract (Loeser, 1977) is available which demonstrated the test substance is not irritating.
Justification for selection of skin irritation / corrosion endpoint:
This study was conducted under GLP according to OECD 404 using rabbits.
Justification for selection of eye irritation endpoint:
This study was conducted under GLP according to OECD 405 using rabbits.
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Skin irritation/corrosion: Mean scores at 24, 48 & 72 hours for erythema were < 2.3 (actual value 0) for oedema were < 2.3 (actual value 0). In addition all reactions were fully reversible within the observation period (worst case was full recovery within 24 hours).
Serious eye damage/eye irritation: Mean scores at 24, 48 & 72 hours for corneal opacity were < 1 (actual value 0), for iritis were < 1 (actual value 0), for conjunctival redness were ≥ 2 (actual value 2.44) and for conjunctival oedema were < 1 (actual value 0.67).
Therefore in accordance with Regulation (EC) No. 1272/2008 Tables 3.2.2 & 3.3.2 the substance is not classified for the skin corrosion/irritation endpoint and classified as "Category 2 (Reversible eye effects)" for the serious eye damage/eye irritation endpoint.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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