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EC number: 422-460-5 | CAS number: 137234-87-8 UK-103,442
- 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:
A study was performed to assess the skin irritation potential of test item to the rabbit following the method described in EC B.4.
No reactions were observed following a single semi-occlusive application of test item to intact rabbit skin for four hours.
Eye irritation:
A study was performed to assess the eye irritation potential of test item to the rabbit following the method as described in EC B.5.
A single instillation of test item into the eye of the rabbit elicited corneal opacification and well-defined to moderate to severe conjunctival irritation. Responses had resolved in all instances by 14 days after instillation.
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 1996-05-29 to 1996-06-1
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- OJ No. L383A, 29.12.92
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Batch No.: Chichibu Lot No. 950704
Purity: 95.7% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK Ltd, Huntingdon, Cambridgeshire, England.
- Age at study initiation: approximately 11 to 14 weeks
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: A standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Ca 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
A 0.5 g amount of the test substance was applied under a 25 mm x 25 mm gauze pad which had been moistened with 0.5 mL distilled water to one intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30 to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
- Clinical signs: daily
- Dermal responses: on Day 1 (ie approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: for all three animal tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: for all three animal tested
- Irritant / corrosive response data:
- No dermal response to treatment was observed in any animal throughout the observation period.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single semi-occlusive application of test item to intact rabbit skin for four hours elicited no dermal irritation.
- Executive summary:
A study was performed to assess the skin irritation potential of test item to the rabbit following the method described in EC B.4.
Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days.
No reactions were observed following a single semi-occlusive application of test item to intact rabbit skin for four hours.
Reference
Individual scores:
Animal No. |
Erythema |
Oedema |
||||||
24 h |
48h |
72 h |
Mean |
24 h |
48h |
72 h |
Mean |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
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 1996-06-03 to 1996-06-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- OJ No. L383A, 29.12.92
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Batch No.: Chichibu Lot No. 950704
Purity: 95.7% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK Ltd, Huntingdon, Cambridgeshire, England.
- Age at study initiation: approximately 12 to 13 weeks
- Weight at study initiation: 2.8 to 3.0 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: A standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Ca 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TREATMENT PROCEDURE
One animal was treated in advance of the others, approximately 100 mg of the test substance, the weight occupying a volume of 0.1 mL, was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.
REMOVAL OF TEST SUBSTANCE
- Washing: Not done
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: handheld light - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Dulling of the normal lustre of the cornea was seen in two animals one hour after instillation. Corneal opacification developed in one of these animals.
No iridial inflammation was seen.
A diffuse crimson to beefy red colouration was seen in all three animals, accompanied in two rabbits by considerable swelling with partial eversion of the eyelids or with the eyelids about half closed.
The reactions gradually ameliorated and the eyes were normal 4, 7 or 14 days after instillation. - Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Instillation of test item into the rabbit eye elicited corneal opacification and well-defined to moderate conjunctival irritation.
- Executive summary:
A study was performed to assess the eye irritation potential of test item to the rabbit following the method as described in EC B.5.
Three rabbits were each administered a single ocular dose of 100 mg of the test substance and observed for a maximum of 14 days after instillation.
A single instillation of test item into the eye of the rabbit elicited corneal opacification and well-defined to moderate to severe conjunctival irritation. Responses had resolved in all instances by 14 days after instillation.
Reference
Individual scores:
Animal No. |
Cornea opacity |
Iris |
Conjunctivae |
Chemosis |
||||||||||||
24 h |
48h |
72 h |
Mean |
24 h |
48 h |
72 h |
Mean |
24 h |
48h |
72 h |
Mean |
24 h |
48h |
72 h |
Mean |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
1 |
1.67 |
2 |
1 |
1 |
1.33 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
1.33 |
1 |
1 |
0 |
0.67 |
3 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
3 |
3 |
2 |
2.67 |
2 |
1 |
1 |
1.33 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation in vivo, EC B.4:
Mean scores of erythema/eschar and oedemas at 24, 48 and 72 hours were all 0 for three test sites after removal of the dressing.
According to Regulation (EC) No 1272/2008, section 3.2.2 and Table 3.2.2, this substance should not be classified for this endpoint.
Eye irritation in vivo: EC B.5:
Mean scores at approximately 24, 48, 72 hours after administration:
Cornea Opacity: 0, 0, 0.67
Iris:0, 0, 0
Conjunctival Redness: 1.67, 1.33, 2.67
Chemosis: 1.33, 0.67, 1.33
According to Regulation (EC) No 1272/2008, section 3.3.2 and table 3.3.2, this substance should not be classified for this 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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