Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate national standard method but full details are not available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test method used was a modification of the French offical method for  testing cosmetics and Toiletries, 1971 & 1973. This method 
(not described  in the publication) after study specific modifications involves the instillation of 0.1 ml or 100 mg undiluted material into the rabbit eye; observations were made at 1h, 1, 2, 3, 4 and 7 days after instillation. 
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Housing: in individual cages (600x540x315 mm)

Test system

Vehicle:
other: 10% aqueous dispersion using an emulsifier and preservative
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1ml

- Concentration (if solution): undiluted and 10% aqueous dispersion using an  emulsifier and preservative

Duration of treatment / exposure:
Single instillation.
Observation period (in vivo):
7 days.
Number of animals or in vitro replicates:
6
Details on study design:
No data

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
other: A maximum score of any of the samples.
Time point:
other: 1h
Score:
7.17
Max. score:
7.17
Reversibility:
fully reversible within: 3 days
Other effects:
The material tested did not provoke pathological lesions of the ocular mucous membrane (such as corneal opacification, ulceration). The observed anomalies were benign, probably of mechanical origin and correspond mainly to congestion of the iris, connjunctival enanthema and slight discharge and/or chemosis.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for Oleyl alcohol, sourcedfrom four different manufacturers.

Score at time point / Reversibility

Irritation of the ocular mucous membrane (interpretation of the results using an evaluation scale from 0 to 100)

 

60 min

7.17/5.83/5.67/5.0

24 h

 0.33/3.17/3.67/0.67

48 h

 0/0.66/2.0/0.0

 

A maximum score for any of the samples was 7.17 observed at 1 hour after  instillation. 

The scores diminished after this and all scores were 0 by  day 3.

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Journal Officiel de la republique Francaise.
Conclusions:
The test substance was found not irritating as determined in a reliable study conducted according to generally accepted scientific principles.