(Z)-octadec-9-enol

Eye irritation

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

Test material information

Constituent 1

Reference substance name:

(Z)-octadec-9-enol

EC Number:

205-597-3

EC Name:

(Z)-octadec-9-enol

Cas Number:

143-28-2

Molecular formula:

C18H36O

IUPAC Name:

(9Z)-octadec-9-en-1-ol

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.