Registration Dossier
Registration Dossier
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EC number: 606-441-0 | CAS number: 201305-16-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- yes
- Remarks:
- (study report with limited information)
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzoic acid, C12-15-alkyl esters
- EC Number:
- 270-112-4
- EC Name:
- Benzoic acid, C12-15-alkyl esters
- Cas Number:
- 68411-27-8
- IUPAC Name:
- 68411-27-8
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: 1950
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.8-2.4 kg
No further details are given in the study report.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye remained untreated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): neat - Duration of treatment / exposure:
- Single administration without washing
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 (mixed sex)
- 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:
- over all 6 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
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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