Registration Dossier
Registration Dossier
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EC number: 264-119-1 | CAS number: 63393-93-1
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 (test substance purity not specified, in 2 of 3 groups eyes were washed 2 and 4 seconds after treatment, limited documentation).
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
- Reference Type:
- secondary source
- Title:
- Final report of the safety assessment for Isopropyl Lanolate.
- Author:
- CIR
- Year:
- 1 980
- Bibliographic source:
- Journal of environmental pathology, toxicology and oncology;4/4, 121-132, 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Draize Method
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test substance purity not specified, in 2 of 3 groups eyes were washed 2 and 4 seconds after treatment, limited documentation
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, lanolin, iso-Pr esters
- EC Number:
- 264-119-1
- EC Name:
- Fatty acids, lanolin, iso-Pr esters
- Cas Number:
- 63393-93-1
- Molecular formula:
- UVCB
- IUPAC Name:
- Fatty acids, lanolin, isopropyl esters
- Details on test material:
- - Name of test material (as cited in study report): isopropyl lanolate, distilled
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye 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
- Observation period (in vivo):
- Reading time points: 24, 48 and 72 h
7 days - Number of animals or in vitro replicates:
- 9 (3 animals without washing, 3 animals with washing 2 seconds after treatment, 3 animals with washing 4 seconds after treatment)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 animals without washing, 3 animals with washing 2 seconds after treatment, 3 animals with washing 4 seconds after treatment
- Time after start of exposure: 2 or 4 seconds
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: without washing, with washing 2 seconds after treatment and with washing 4 seconds after treatment
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: without washing, with washing 2 seconds after treatment and with washing 4 seconds after treatment
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: without washing, with washing 2 seconds after treatment and with washing 4 seconds after treatment
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Remarks on result:
- other: without washing, with washing 2 seconds after treatment and with washing 4 seconds after treatment
- Irritant / corrosive response data:
- No eye irritation was observed in any of the animals.
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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