Registration Dossier
Registration Dossier
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EC number: 231-306-4 | CAS number: 7491-02-3
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: Comparable to guideline study with acceptable restrictions (lack of details on test substance and test animals) .
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (limited documentation and reporting)
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Labeling Act (FHSLA, 1964).
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Diisopropyl sebacate
- EC Number:
- 231-306-4
- EC Name:
- Diisopropyl sebacate
- Cas Number:
- 7491-02-3
- Molecular formula:
- C16H30O4
- IUPAC Name:
- 1,10-bis(propan-2-yl) decanedioate
- Details on test material:
- - Name of test material (as cited in study report): Decanedioic acid, bis(1-methylethyl) ester
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days (as no irritation reaction was observed)
Reading time points: 1, 24, 48 and 72 h, 4 and 7 days - Number of animals or in vitro replicates:
- 6
- Details on study design:
-
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No irritating effects were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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