Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: documentation incomplete; no information on exposure time

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:
0.5 ml undiluted test substance was applied to the intact and abraded skin, time of observation: 24 and 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

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

Test system

Type of coverage:
not specified
Preparation of test site:
other: shaved intact skin or shaved and abraded skin
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml undiluted
Duration of treatment / exposure:
no data
Observation period:
up to 72 hours
Number of animals:
6 rabbits intact skin and 6 rabbits abraded skin
Details on study design:
reading for erythema and edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: mean score of each animal
Time point:
other: abraded and intact skin. after 72 hours
Score:
ca. 4
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal: mean score of each animal
Time point:
other: abraded and intact skin: after 72 hours
Score:
ca. 4
Max. score:
4
Reversibility:
no data
Irritation parameter:
overall irritation score
Basis:
other: mean value over all animals
Time point:
other: abraded and intact skin: after 72 hours
Score:
ca. 8
Max. score:
8
Reversibility:
no data
Irritant / corrosive response data:
no further data
Other effects:
no further data

Any other information on results incl. tables

intact skin:   erythema: 24 hr: Score 4 in 6/6
                                 72 hr: Score 4 in 6/6
                edema:    24 hr: Score 4 in 6/6          
                                 72 hr: Score 4 in 6/6
abraded skin:  erythema: 24 hr: Score 4 in 6/6
                                72 hr: Score 4 in 6/6
                      edema:    24 hr: Score 4 in 6/6
                                    72 hr: Score 4 in 6/6
no tissue destruction and /or necrosis reported

Summary: irritation score: 8.00/8.00

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Executive summary:

Application of 0.5 ml undiluted p-cresol on shaved intact or abraded rabbit skin areas (coverage and exposure time not mentioned) and reading up to 72 hours post application yielded mean irritation score 8 of max. 8. Reversibility is not reported.