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EC number: 425-020-0 | CAS number: 191680-81-6 CGL 116
- 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 test substance demonstrated no persistent skin irritation in a reliable study with rabbits. Furthermore, no notable eye irritation was observed in the key study for eye irritation, minor changes were fully reversible. Due to these findings the test substance is considered to be 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:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles and is acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: 1/cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times per week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: controlled
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g/rabbit - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 x 2.5 cm surgical gauze patch; the patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed from the test site by gentle washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to the Draize system - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Erythema with max. score of 1 in two animals was noted at 60 min time point, reversible within 24 hours.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- In two animals, slight erythemas (score = 1) were noted 30 - 60 minutes after patch removal and cleared by 24 hours. Edema was absent at all observation intervals.
- Other effects:
- There were no abnormal systemic signs noted during the observation period.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test article caused only minimal skin reactions in 2/6 animals and is therefore considered to be not irritating to the rabbit skin.
- Executive summary:
In a primary dermal irritation study according to OECD guideline 404, six female New Zealand White rabbits were dermally exposed to the test item for four hours in a semi-occlusive manner. 0.5 g of the test substance was placed on a clipped but intact area of the torso and held in place by a gauze patch moistened with distilled water. After 4 hours the wrappings were removed and residual test article was removed from the test site by gentle washing with distilled water. Dermal reactions were then scored according to the Draize scoring system at 30-60 min, 24, 48 and 72 hours after removal of the test substance. Only minimal erythema reactions were observed in two animals, reversible within 24 hours. All other scores for erythema and edema were zero. There were no abnormal systemic signs noted during the observation period. Therefore, based on this result, the test substance is considered to be not irritating to the 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:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles and is acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand Black
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown. PA
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: 1/cage in suspended cages, bedding was placed beneath the cages and changed at least three times per week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: controlled
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml equivalent (12 mg) - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: hand-held lamp and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Iritis noted in 2/6 animals, cleared by 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.39
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- There was no corneal opacity noted at any observation period. Iritis noted in 2/6 eyes, cleared by 24 hours. Minimal conjunctival irritation noted in 6/6 eyes, cleared by 72 hours the latest.
- Other effects:
- There were no abnormal systemic signs noted during the observation period.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test substance caused only minimal ocular reactions below the level of regulatory significance and is therefore classified as not irritating to the rabbit eye.
- Executive summary:
- In an eye irritation study performed according to OECD guideline 405, six New Zealand White rabbits were treated with 12 mg (equivalent to 0.1 ml) of the test article. The test article was placed into the conjunctival sac of one eye of each animal; the lids were then held together for about one second in order to prevent loss of the test material. The untreated eye served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after instillation and animals were checked daily for signs of systemic toxicity. In two animals iritis was noted at the 1 hour time point, reversible within 24 hours. Additional ocular reactions were recorded for the conjunctivae of all animals. However, the reactions were only minimal and reversible within 72 hours the latest. Since all reactions were well below the threshold of regulatory significance, the test article is considered as not irritating.
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 test article's potential to cause dermal irritation was assessed in an irritation study following OECD guideline 404 (MB Research Labs, MB 975706.03, 1997). An amount of 0.5 g of the test substance was applied topically to the intact skin of six female New Zealand White rabbits for 4 hours under semi-occlusive dressing. In two animals slight erythema reactions were observed 30 -60 minutes after removing of the dressing, reversible within 24 hours. All scores at 24, 48 and 72 hour time points were zero. There were no abnormal systemic signs noted during the observation period. Overall, only minimal skin reactions could be observed and in conclusion, under the test conditions chosen, the test substance is not considered to be irritating to the skin.
Eye irritation
To assess the acute eye irritation potential of the test substance in vivo, an irritation study with six New Zealand white rabbits was performed according to OECD guideline 405 (MB Research Labs, MB 975706.04, 1997). An amount of 12 mg (equivalent of 0.1 ml) of the test substance was applied into the conjunctival sac of one eye of each animal and the ocular reactions were evaluated 1, 24, 48, and 72 hours after instillation. All animals displayed minimal reactions to the conjunctivae (reddening, chemosis and discharge), all of which were reversible to normal within 72 hours the latest. Average scores for conjunctival redness and chemosis were 0.39 and 0.25, respectively. In two animals, iritis was observed at the 1 hour time point, reversible within 24 hours. The scores for edema were zero at any time point. Since the observed reactions were minimal and below the regulatory threshold of significance, the test article is considered to be not irritating to the rabbit eye.
Respiratory Irritation
No data
Justification for selection of skin irritation / corrosion endpoint:
Study acceptable for assessment
Justification for selection of eye irritation endpoint:
Study acceptable for assessment
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 the purpose of classification under Regulation (EC) No.1272/2008.
Based on the data, the test substance is not classified as skin or eye irritant
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