Registration Dossier
Registration Dossier
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EC number: 946-091-9 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer to the Analogue Approach Justification document provided in IUCLID6 Section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sulfuric acid, mono-C12-16-alkyl esters, ammonium salts
- EC Number:
- 292-210-6
- EC Name:
- Sulfuric acid, mono-C12-16-alkyl esters, ammonium salts
- Cas Number:
- 90583-12-3
- IUPAC Name:
- Sulfuric acid, mono-C12-13-alkyl esters, potassium salts
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse
- Details on test animals or tissues and environmental conditions:
- According to Guideline
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- n.a.
- Observation period (in vivo):
- 1, 6, 24, 48, and 72 hours and 7, 10, 14, 17, and 21 days after treatment
- Number of animals or in vitro replicates:
- 1 (severe irritation was expected)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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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