Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
Method: other: 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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: 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:
other: 24 hour reading
Score:
ca. 91.3
Max. score:
110
Irritation parameter:
other: cornea score, iris score, conjunctivae score
Basis:
mean
Time point:
other: 48 hour reading
Score:
ca. 86.3
Max. score:
110
Irritation parameter:
other: cornea score, iris score, conjunctivae score
Basis:
mean
Time point:
other: 72 hour reading
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
Irritant / corrosive response data:
no further data
Other effects:
none reported

Any other information on results incl. tables

RS-Freetext:
Total irritation score: 91.3/110

Applicant's summary and conclusion

Executive summary:

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