Registration Dossier
Registration Dossier
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EC number: 293-917-2 | CAS number: 91648-55-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Lack on details of test substance. However details were achieved from the sponsor.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sulfuric acid, mono-C12-16-alkyl esters, sodium salts
- EC Number:
- 277-362-3
- EC Name:
- Sulfuric acid, mono-C12-16-alkyl esters, sodium salts
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- According to Guideline.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye damage 1, H318. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)
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