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EC number: 205-593-1 | CAS number: 143-23-7
- 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
In a reliable skin irritation study in rabbits the submission substances induced scar formation and thus is assessed as corrosive to skin. In an eye irritation study similar to OECD TG 405 irreversible damage was observed when the submission substance was administered to the eyes of rabbits.
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:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines /standards
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- prolonged exposure period, one additional animal; despite corrosiveness testing in all animals at the same time with long exposure period; additional application on scarified skin
- Qualifier:
- according to guideline
- Guideline:
- other: DRAIZE test published in "Appraisal of the safety of chemicals in foods and cosmetics" Association of Food and Drug Officials of the United States, published by the Editorial Committee, Baltimore (1959), p. 46
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study performed before GLP statement
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.2 to 2.9 kg - Type of coverage:
- occlusive
- 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): 0.5 mg (solid test material humidified with a little bit of water) - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: two sites were shaved on the back of each animal, one of these was subsequntly sarified before the test item was applied
SCORING SYSTEM:
erythema scores similar to DRAIZE scoring system used in OECD 404
Erythema scores
0: none
1: very slight (barely perceptible)
2: slight (well perceptible)
3: moderate to severe
4: very severe erythema with slight eschar formation
8: very severe erythema and expanded eschar formation (over 50% of the apllication area)
Edema scores resemble those of OECD 404 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 24 h after start of exposure
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: intact skin
- Remarks:
- all animals showed the same score
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 72 hours after start of exposure
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- no data
- Remarks:
- on reversibility as this was the final period of time investigated in the study
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 24 hours after start of exposure
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: intact skin
- Remarks:
- all animals showed the same score
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 72 hours after start of exposure
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks:
- on reversibility as this was the final period of time investigated in the study
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 24 after start of exposure
- Score:
- 4
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: scarified skin
- Remarks:
- individual scores: 8, 2, 4, 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 72 hours after start of exposure
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- no data
- Remarks:
- on reversibility as this was the final period of time investigated in the study
- Remarks on result:
- other: scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 24 hours after start of exposure
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: scarified skin
- Remarks:
- all animals showed the same score
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 72 hours after start of exposure
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks:
- on reversibility as this was the final period of time investigated in the study
- Remarks on result:
- other: scarified skin
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Remarks:
- study design does not allow to disciminate further into subcategories
- Conclusions:
- According to the authors of this study the test item was found to be extremely irritant to the skin of rabbits under the conditions tested.
- Executive summary:
In order to test primary skin irritation 4 New Zealand White rabbits were treated the submission substance. 0.5 mg of solid test material (pasted with water) were applied onto the intact skin as well as on scarified skin of the animals and held in contact with skin for 24 h (occlusive conditions). Reading was performed 24 h and 72 h after start of the application. According to the authors of this study the test item was found to be extremely irritant to the skin of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines /standards
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : one additional animal
- Qualifier:
- according to guideline
- Guideline:
- other: DRAIZE test published in "Appraisal of the safety of chemicals in foods and cosmetics" Association of Food and Drug Officials of the United States, published by the Editorial Committee, Baltimore (1959), p. 46
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study performed before GLP statement
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 2.6 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Substance application was performed once, without any washing subsequently.
- Observation period (in vivo):
- 7 days (Ocular reactions were observed at 1hour, 24, 48 and 72 hours after the instillation and then at days 7.)
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- SCORING SYSTEM: according to OECD TG 405 (Draize scale), reading at 1 h, 1, 2, 3, 4 and 7 days after removal of test item
The test item was instilled into the lower conjunctival sac of the left eye of each test animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- of animal #1, #2, and #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritant / corrosive response data:
- Within 2 days post instillation the reading of all characteristics (i.e. corneal opacity, iris, conjunctivae redding, chemosis) in all animals resulted in maximum scores (see above), which were not reversible within 7 days post application.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions tested the test item induced serious damage to eyes (corrosive).
- Executive summary:
The primary eye irritation potential of the test item was investigated similar as described in OECD testing guideline no 405. The test item (0.1 g) was applied into the lower left conjunctival sac of the intact eye of four New Zealand White rabbits. Reading times were 1 h, 1, 2, 3, 4 and 7 days post instillation. Within 2 days post instillation the reading of all characteristics (i.e. corneal opacity, iris, conjunctivae redding, chemosis) in all animals resulted in maximum scores, which were not reversible within 7 days post application.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In order to test primary skin irritation 4 New Zealand White rabbits were treated the submission substance. 0.5 mg of solid test material (pasted with water) were applied onto the intact skin as well as on scarified skin of the animals and held in contact with skin for 24 h (occlusive conditions). Reading was performed 24 h and 72 h after start of the application. According to the authors of this study the test item was found to be extremely irritant to the skin of rabbits.
The primary eye irritation potential of the submission substance was investigated similar as described in OECD testing guideline no 405. The test item (0.1 g) was applied into the lower left conjunctival sac of the intact eye of four New Zealand White rabbits. Reading times were 1 h, 1, 2, 3, 4 and 7 days post instillation. Within 2 days post instillation the reading of all characteristics (i.e. corneal opacity, iris, conjunctivae redding, chemosis) in all animals resulted in maximum scores, which were not reversible within 7 days post application.
Justification for classification or non-classification
Based on the results of the reliable eye irritation study which is available for the submission substance and according to the criteria set in Regulation (EC) No. 1272/2008 the submission substance is classified for Irreversible effects on the eye/serious damage to eyes (Category 1).
Based on the results of the reliable skin irritation study and according to the criteria set in Regulation (EC) No. 1272/2008 section 3.2.2.6.1. the submission substance is identified as being corrosive to skin. However no definite subcategory with criteria described in Regulation (EC) No. 1272/2008 Table 3.2.1 could be chosen as the study design (exposure period 4 hours) did not allow for further discrimination, thus the strongest classification as Corrosive subcategories 1A was assigned.
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