Registration Dossier
Registration Dossier
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EC number: 914-129-3 | CAS number: 12336-95-7
Eye irritation
Administrative data
- 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: Proprietary study reported in summary form only
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Proprietary study reported in summary only
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test method used 24-hour of semi-occlusive exposure of the interior surface of the ear of 2 rabbits.
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: solitary - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 500 mg/animal
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Type of wrap if used: bandage dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water and soap/plant oil
- Time after start of exposure: 24 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Results are not reported in detail, however the report states that the test material is not irritating to skin.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Although the irritation scores are not reported, it is concluded that the test material is not a skin irritant.
- Executive summary:
500 mg of the test material was applied under semi-occlusive conditions to the interior surface of the ears of two New Zealand White rabbits. Residual test material was removed after 24 hours by washing with soap and water; animals were obsereved for 7 days. Scores for irritation are not reported, however it is stated in the report that the test material was not a skin irritant under the conditions of the study. The study protocol is not standard, however it can be concluded that the substance is not a skin irritant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study method is broadly comparable to OECD 405.
- GLP compliance:
- no
- Remarks:
- (the study pre-dates GLP)
Test material
- Reference substance name:
- Chromium hydroxide sulphate
- EC Number:
- 235-595-8
- EC Name:
- Chromium hydroxide sulphate
- Cas Number:
- 12336-95-7
- Molecular formula:
- CrHO5S
- IUPAC Name:
- chromium hydroxide sulphate
- Details on test material:
- The test material is referred to by the tradename 'Chromsal B'
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: solitary
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 50 mg/animal
- Duration of treatment / exposure:
- Single exposure; no details on washing
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- no details provided
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: single exposure
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: single exposure
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: single exposure
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: single exposure
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: single exposure
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: single exposure
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: single exposure
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: single exposure
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- The scores for eye irritation are not reported, however it is stated that the test material was not found to be a primary eye irritant in this study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not irritating to the rabbit eye under the conditions of this study
- Executive summary:
50 mg of the test material was instilled into one eye of two New Zealand White rabbits; ocular reactions were observed for 7 days. Scores for eye irritation are not reported, however the test material was not irritating to the rabbit eye under the conditions of this study.
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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