Registration Dossier

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: no information on GLP, strain used

Data source

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

Materials and methods

Principles of method if other than guideline:
0.1 ml undiluted test substance was applied into the eye of rabbits, time of reading: 24, 48, 72 hrs
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: p-cresol, M.P.: 36°C, B.P.: 202°C

Test animals / tissue source

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

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:
unspecified
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
no further data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: mean score cornea, iris, conjunctivae
Basis:
animal: mean score of all animals
Time point:
other: 72 hours
Score:
ca. 93
Max. score:
110
Irritation parameter:
other: mean score cornea, iris, conjunctivae
Basis:
animal: mean score of all animals
Time point:
other: 48 hours
Score:
ca. 89.7
Max. score:
110
Irritation parameter:
other: mean score: cornea, iris conjunctivae
Basis:
animal: mean score for all animals
Time point:
other: 24 hours
Score:
ca. 84.7
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal: all animals
Time point:
other: up to 72 hours
Score:
ca. 89
Max. score:
110
Reversibility:
not reversible
Remarks on result:
other: (mean over total observation period)

Any other information on results incl. tables

24 hours: cornea, iris, conjunctivae: 84.7/110 (mean score)
mean score for cornea: 60; mean score for iris: 10; mean score for conjunctivae: 14.7  48 hours: cornea, iris, conjunctivae: 89.7/110 (mean score)
mean score for cornea: 63.3, mean score for iris: 10, mean score for conjunctivae: 16.3 72 hours: cornea, iris, conjunctivae: 93.0/110 (mean score)
mean score for cornea: 66.6, mean score for iris: 10; mean score for conjunctivae: 16.3 summary: irritation score: 89.0/110

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Executive summary:

The application of 0.1 ml undiluted p-cresol into the eyes of rabbits followed by an obervation period of upto 72 hours resulted in mean irritation score 89 of max 110. Reversibility is not reported.