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EC number: 433-240-3 | CAS number: -
- 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
The eye irritating potential of the test item was assessed according to OECD TG 405. Three rabbits were exposed to 0.1 mg test item. The mean score was calculated across three scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals.
The individual mean scores for the conjunctivae were 0.00, 0.00 and 0.33 for reddening and 0.00, 0.00 and 0.67 for chemosis for all animals, respectively.One hour after instillation all treated animals showed slight conjunctival redness (score 1) and one animal showed also slight chemosis (score 1).All effects were fully reversible within 72 h.
The eye irritating potential of the test item was assessed according to OECD TG 405. Three rabbits were exposed to 0.1 mg test item. The mean score was calculated across three scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals.
The individual mean scores for the conjunctivae were 0.00, 0.00 and 0.33 for reddening and 0.00, 0.00 and 0.67 for chemosis for all animals, respectively.One hour after instillation all treated animals showed slight conjunctival redness (score 1) and one animal showed also slight chemosis (score 1).All effects were fully reversible within 72 h.
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 31 AUG 1999 to 09 SEP 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17 JUL 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 31 JUL 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombres, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: male: 13 weeks, females 14-15 weeks
- Weight on day of treatment: male 2467 g, females 2937 and 2583 g
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintainance diet, ad libitum, haysticks provided by Eberle Nafag AG, CH-9200 Gossau
- Water: Community tap water, ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.5 g/animal, moistened with bi-distilled water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: substance applied on surgical gauze patch, covered with semi-occlusive dressing, wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm tap water
- Time after start of exposure: 4 h, at the end of exposure time
OBSERVATION TIME POINTS
1, 24, 48 and 72 h after removal of the test substance
SCORING SYSTEM:
- Method of calculation: The skin reactionwas assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEc, July 31, 1992.
The primary irritation score was calculated by totalling the individual cummulative scores at 24, 48 and 72 h and then dividing by the number of data points. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corrosive or irriating effects observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not reveal any irritation potential on the skin of rabbits, tested in this study according to OECD test guideline no. 404 and GLP conditions.
- Executive summary:
The skin irritating potential of the test item was assessed according to OECD TG 404. Three rabbits (1 male and 2 females) were exposed to 0.5 mg test item under semi-occlusive conditions for 4 hours. Yellow staining produced by the colour of the test item on the treated skin was observed in all animals at the 1-hour reading and persisted up to the 48- or 72-hour reading. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Reference
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality ocurred.
Yellow stainig of the treated skin was observed.
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 07 SEP 1999 to 16 SEP 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 FEB 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 31 JUL 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombres, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: females 14 weeks, males 15 weeks
- Weight at study initiation: male 2601 g, females 2548 and 2826 g
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintainance diet, ad libitum, haysticks provided by Eberle Nafag AG, CH-9200 Gossau
- Water: Community tap water, ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g/animal
- Duration of treatment / exposure:
- test substance was not removed from the eye
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: The occular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 32, 1992.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Slightly reddened conjunctivae was observed in all three animals 1 h after application. The effect remained in one animal at the 24 hour reading, but was fully reversible within 48 h.
One hour after instillation one animal showed also slight chemosis (score 1). - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortalities ocurred. Yellow remnants in eye or conjunctival sac and around eye and /or on lids by the test article were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not induce significant or irreversible damage to the rabbit eye in this study according to OECD test guideline no. 405 and GLP conditions.
- Executive summary:
The eye irritating potential of the test item was assessed according to OECD TG 405. Three rabbits were exposed to 0.1 mg test item. The mean score was calculated across three scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals.
The individual mean scores for the conjunctivae were 0.00, 0.00 and 0.33 for reddening and 0.00, 0.00 and 0.67 for chemosis for all animals, respectively. One hour after instillation all treated animals showed slight conjunctival redness (score 1) and one animal showed also slight chemosis (score 1). All effects were fully reversible within 72 h.
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
No classification
Neither on skin nor on eyes of rabbits in vivo relevant signs of irritation were recorded
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