Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 March 1974 to 18 April 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: US Federal Hazardous Substances Labelling Act
Principles of method if other than guideline:
The method employed in the testing was similar to that described in Section 1500.41 - Hazardous Substances and Articles. Administration and Enforcement Regulations, Federal Register, Vol 38 No 187 P.27019, 27 September 1973. Six albino rabbits were clipped, one side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used
GLP compliance:
no
Remarks:
Prior to GLP

Test material

Constituent 1
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No details on test animals and environment provided

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Clipped with abraded and intact sites on each animal
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
24 hour occlusive exposure. The sites were not washed after the patches were removed.
Observation period:
24 and 72 hours
Number of animals:
6
Details on study design:
Six albino rabbits were clipped, one side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 & 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 & 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 & 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 & 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24 & 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24 & 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 & 72 houts
Score:
0
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 & 72 hours
Score:
0
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 & 72 hours
Score:
0
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24 & 72 hours
Score:
0
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24 & 72 hours
Score:
0
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24 & 72 hours
Score:
0
Max. score:
4
Reversibility:
no data
Irritant / corrosive response data:
Intact skin only
The test item elicited a well defined erythema response in all animals at the 24 and 72 hour observation. No other irritation response were noted.

Any other information on results incl. tables

Irritation effects on the intact skin only are considered for classification purposes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.
Executive summary:

Introduction

The study was performed in accordance with the US Federal Hazardous Substances Labelling Act to assess the irritancy potential of the test item to the skin of rabbits.

Method and materials

The intact and abraded skin of 6 rabbits was used. The hair was clipped from the backs of the rabbits. One side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. GauzE patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used.

Results

A single 24-Hour, occluded application of the test item to the intact skin of six rabbits produced a well defined erythema response in all six animals at the 24 & 72 -hour observation No other irritation responses were noted.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.