Registration Dossier
Registration Dossier
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EC number: 246-805-2 | CAS number: 25306-75-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Severe effects seen in three rabbits. Study terminated after 3 days for humane reasons
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Severe effects seen in three rabbits. Study terminated after 3 days for humane reasons
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium isobutyl xanthate
- IUPAC Name:
- Sodium isobutyl xanthate
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Physical state: orangee liquid- Analytical purity: 456,1g/dm3- ph=10.1
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age: 4 monthWeight: 2.9 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- 0,5 ml of water solution pH=10, containing 456,1g/dm3 of SIX, on 2,5x25cm of shaved skin
- Duration of treatment / exposure:
- 4 hours exposure
- Observation period:
- 1; 24; 48 and 72 h
- Number of animals:
- 3 male
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Terminated at 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours.
- Remarks on result:
- other: Terminated at 72 hours
- Irritant / corrosive response data:
- observation after 1h – bloody effusions, moderate swelling, oedema, after 24 ,48 and 72h – tinea on the exposition place and around redness, oedema.
Any other information on results incl. tables
| Animal nr | 1 24 48 72 | |
| erythema | 1 | 4 4 4 4 |
| 2 | 4 - - - | |
| 3 | 4 4 4 4 | |
| oedema | 1 | 3 3 3 3 |
| 2 | 3 - - - | |
| 3 | 3 3 3 3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Sodium isobutyl xanthate can be assessed as a substances strongly irritating skin of rabbits
- Executive summary:
Severe effects seen in three rabbits. Study terminated after 3 days for humane reasons
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