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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The eye reactions were scored according to Draize.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No detail available.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
7 days (Scored at 1, 24, 48, 72, 120 and 168 hours).
Number of animals or in vitro replicates:
3M, 3F
Details on study design:
Eyes rinsed with warm isotonic solution after the 24 hour reading.

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24h
Score:
13.3
Max. score:
110
Reversibility:
fully reversible within: 120 hours
Irritant / corrosive response data:
AVERAGE SCORE (24+48+72 hour) 10.7/110 combined cornea, iris and conjunctivae.

Any other information on results incl. tables

The individual scores were not reported only the calculated Draize scores.


DESCRIPTION OF LESIONS: There was immediate slight discomfort with slight redness and copious discharge at 10 minutes which developed to 

slight to moderate redness with copious discharge at 1 hour. At 24 hours there was barely perceptible corneal dullness, the reaction of the iris to 

light was sluggish in 2 rabbits (maximum score 1), conjunctival involvement (slight to moderate redness with whitish discharge) was observed in 

all eyes at this time period.

REVERSIBILITY: After 24 hours there was a gradual improvement through to 120 hours when the iris and cornea appeared normal. All eyes 

appeared  completely normal by 7 days.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Undecyl alcohol is described as slightly irritating to the eye in this test. Under GHS criteria the results suggest classification as mild. Under EU criteria undecyl would not be considered irritant.