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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: sufficient information to evaluate the substance

Data source

Reference
Reference Type:
publication
Title:
Bio-Fax data sheet: o-cresol
Author:
Industrial Bio-Test Laboratories Inc.
Year:
1969
Bibliographic source:
Data sheet no 4-5/69, Industrial Bio-Test Laboratories Inc. Northbrook, Ill, USA

Materials and methods

Principles of method if other than guideline:
Application of 0.1 ml of the undiluted substance into the eye of each of 6 rabbits reading 24hrs, 48 hrs and 72 hours: cornea, iris, conjunctivae.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
o-cresol
EC Number:
202-423-8
EC Name:
o-cresol
Cas Number:
95-48-7
Molecular formula:
C7H8O
IUPAC Name:
o-cresol
Details on test material:
o-cresol, no data on purity, MP 30 °C

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no further information

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye served as control
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
no data
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Comment: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: cornea score, iris score, conjunctivae score
Basis:
mean
Time point:
24 h
Score:
ca. 91.3
Max. score:
110
Irritation parameter:
other: cornea score, iris score, conjunctivae score
Basis:
mean
Time point:
48 h
Score:
ca. 86.3
Max. score:
110
Irritation parameter:
other: cornea score, iris score, conjunctivae score
Basis:
mean
Time point:
72 h
Score:
ca. 82.7
Max. score:
110
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: after 72 hour reading
Score:
ca. 91.3
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for edema score avaiable. Total irritation score: 91.3/110
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for iris score avaiable. Total irritation score: 91.3/110
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for conjunctivae score avaiable. Total irritation score: 91.3/110
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for chemosis score avaiable. Total irritation score: 91.3/110
Irritant / corrosive response data:
no further data
Other effects:
none reported

Any other information on results incl. tables

Total irritation score: 91.3/110.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

Application of 0.1 ml undiluted testsubstance into the eyes of rabbits and observation for up to 72 hours resutlted into a mean score of 97 of max 110. Reversibility is not reported (Industrial Biotest Laboratories 1969).