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EC number: 931-228-7 | 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
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Endpoint summary
Administrative data
Description of key information
Based on the experimental results it is concluded that the submission substance has to be classified as skin corrosive Cat. 1A and eye irritating Cat. 1 according to Regulation (EC) No. 1272/2008.
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:
- January and February 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study based on national and scientific standards, basic data given, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: SOP No. CT20-137, version 01 (ICI)
- Principles of method if other than guideline:
- reduced exposure time, below 4 h
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- not specified
- Preparation of test site:
- other: shaved, intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 1 h and 3 min
- Observation period:
- 1, 4, 24, 48, and 96 h (after 1-h exposure),
4, 24, 48, and 72 h (after 3-min exposure) - Number of animals:
- 6 each
- Details on study design:
- no data
- Irritation parameter:
- overall irritation score
- Remarks:
- necrosis
- Basis:
- other: 2/6 animals (1-h exposure)
- Time point:
- other: 4 h p.a.
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive: => not quantitively evaluable, descriptive rating: Scores are surrogates.
- Irritation parameter:
- overall irritation score
- Remarks:
- necrosis
- Basis:
- other: 6/6 animals (1-h exposure)
- Time point:
- other: 24, 48, and 96 h p.a.
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive: => not quantitively evaluable, descriptive rating: Scores are surrogates.
- Irritation parameter:
- overall irritation score
- Remarks:
- necrosis
- Basis:
- other: 5/6 animals (3-min exposure)
- Time point:
- other: 4 h p.a.
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive: => not quantitively evaluable, descriptive rating: Scores are surrogates.
- Irritation parameter:
- overall irritation score
- Remarks:
- necrosis
- Basis:
- other: 6/6 animals (3-min exposure)
- Time point:
- other: 24, 48, and 72 h p.a.
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive: => not quantitively evaluable, descriptive rating: Scores are surrogates.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no erythema score could be derived.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no erythema score could be derived.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no erythema score could be derived.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no erythema score could be derived.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no erythema score could be derived.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no erythema score could be derived.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no edema score could be derived.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no edema score could be derived.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no edema score could be derived.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no edema score could be derived.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no edema score could be derived.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the corrosivity no edema score could be derived.
- Irritant / corrosive response data:
- After exposure of 1 h, tissue destruction was observed in 2/6 animals after 4 h post-application and in all animals at 24 through 96 h It was characterised by thickened, dark, necrotic skin with slight hardening and surrounded by an area of blanched skin edged with erythematous skin.
After exposure of 3 min, similar signs of tissue destruction were observed 4 h post-application. - Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The test item caused corrosive responses under the conditions of this test.
- Executive summary:
The effect of the test item on rabbit skin was assesed in oder to classify the potential corrosivity according to standard operating procedure no. CT20 -137, Version 01.
In a first study, the test item was applied for one hour on abraded and intact skin of six rabbits, respectivetly. Tissue destruction was observed in two out of six animals at 4 hours and in all six animals at 24 hours after application. It was characterised by thickened, dark, necrotic skin with slight hardening and surrounded by an area of blanched skin edged with erythematous skin.
Similar signs of tissue destruction were observed 4 hours after a 3 -minute application of the test item.
Reference
Observations after 3 -minute application:
Test Site | Ratio of 6 Rabbits | ||||
4 hr | 24 hr | 48 hr | 96 hr | ||
Abraded | 5/6 | 6/6 | 6/6 | 6/6 | |
Intact | 5/6 | 6/6 | 6/6 | 6/6 |
Observations after 1 -hour application:
Test Site | Ratio of 6 Rabbits | ||||
1 hr | 4 hr | 24 hr | 48 hr | 96 hr | |
Abraded | 0/6 | 2/6 | 6/6 | 6/6 | 6/6 |
Intact | 0/6 | 2/6 | 6/6 | 6/6 | 6/6 |
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study based on national and scientific standards, basic data given, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- according to standard procedure, grading of effects based on the numerical scoring systems after Draize 1959
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Huntingdon
- Housing: individually in metal cages
- Diet: ad libitum
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 2 days
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: numerical scale according to Draize, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Appendix 2, 1959.
The results were interpreted using a modification of the method recommended by Kay and Calandra, Journal of the Society of Cosmetic Chemists, 13 (6), 281-9, Appendix 3, 1962. - Irritation parameter:
- overall irritation score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: day 1 and 2
- Score:
- 110
- Max. score:
- 110
- Reversibility:
- not reversible
- Remarks on result:
- other: not quantitively evaluable / descriptive rating: very to extremely severe irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Due to the severity of the reactions the animals were all sacrificed on day 2.
- Irritant / corrosive response data:
- Corneal damage in all animals, severe conjunctival swelling extending beyond the limits of the orbit, resulting in total eye closure.
No assessment of the degree of inflammation reaction possible.
All three animals had to be killed on day 2 for humane reasons. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- On instillation of the test item the animals showed moderate initial pain.
Corneal damage was produced in all three animal but assesment of the degree and extent was precluded by the severe conjuctival swelling. Considerable swelling of the conjuctivae extending well beyond the limits of the orbit resulting in complete closure of the eye was observed in all three rabbits. It was impossible to asses the degree of inflammation.
Due to the severity of the reactions the animals were all sacrificed on day 2. - Executive summary:
In an in vivo eye irritation study three albino rabbits of the New Zealand White strain were treated with 1 drop (0.1 mL) of the test substance per one eye.
The test item caused moderate to severe initial pain (3 -4 on a 5 point scale according to Kay and Calandra, 1962) which was followed by extremely severe irritation which was impossible to score. No readings could be taken if the iris and cornea due to swelling accomapnied by a great amount of discharge. Histopathological examination of sections of the eye 2 days after the installation showed the material to cause severe conjunctivitis, diffuse necrosis and inflammation of the anterior chamber.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
In an in vivo study six rabbits were dermally exposed for 1 -hour towards the test item. In all animals 24 hours after application, the test item caused thickened, dark, necrotic skin with slight hardening surrounded by an area of blanched skin edged with erythematous skin. Similar signs were also observed by a 3 -minute application of the test item and already 4 hours after application.
Based on these results the substance would be considered as corrosive to skin (CLP: Cat. 1A).
The instillation of 1 mL test item in course of an in vivo eye irritation study on three rabbits caused moderate to severe initial pain followed by extremely severe irritation impossible to score. Due to the severity of the effects all animals were sacrified on day 2.
Based on these results the substance would be considered as eye irritating, Cat. 1 (CLP).
Justification for classification or non-classification
Based on the experimental results it is concluded that the submission substance has to be classified as skin corrosive Cat. 1A and eye irritating Cat. 1 according to Regulation (EC) No. 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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