Registration Dossier
Registration Dossier
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EC number: 248-470-8 | CAS number: 27458-93-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23rd -30th January 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isooctadecan-1-ol
- EC Number:
- 248-470-8
- EC Name:
- Isooctadecan-1-ol
- Cas Number:
- 27458-93-1
- Molecular formula:
- C18H38O
- IUPAC Name:
- 2-methylheptadecan-1-ol
- Reference substance name:
- Isostearyl alcohol
- IUPAC Name:
- Isostearyl alcohol
- Test material form:
- other: Liquid
- Details on test material:
- Priosorine 3515 Iso-Stearyl Alcohol Nr 82350
Thick yellow liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- 1,24. 48, 72 hours post treatment.
- 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:
- other: 1 hour
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 4.7
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24,48,72 hour
- Score:
- 0
- Max. score:
- 10
Any other information on results incl. tables
A very slight enanthema together with chemosis was observed at the 1 hour reading in all test animals, but was fully reversed by 24 our reading. No lesion of the iris or cornea was observed at any of the observation time points.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a well conducted in vivo eye irritation study using Isostearyl alcohol (OECD 405, GLP) minor transient irritation was observed after one hour. No other treatment related ocular effects were subsequently recorded. On the basis of these findings, Isostearyl alcohol is not classifed as irritating to eyes.
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