Registration Dossier

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:
14th March 1977 to 4th April 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Older in vivo study used as read-across. No further in vivo studies conducted due to cosmetic use. See attached read across justification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
No observation at 48 hours, as only mild irritation scores were observed it is not thought to impact the results of the test.
Principles of method if other than guideline:
The intact and abraded skin of 3 rabbits was used. The hair was clipped from the backs of the rabbits using angora clippers. Four areas of the back, places ca. 10 cm apart were designated for the patches. Areas 2and 3 were abraded by making four epidermal incisions (two perpendicular to two others in the area of the patch). The patches consisted of layers of light gauze cut in aquares (2.5 cm sides). The patches were secured to the area by thin bands of adhesive tape. The material was introduced (0.5 mL) beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands. The test material and control, if using, were applied so that there were two applications to each of 3 animals (one intact, one abraded). The animals were immobilised for the 24 hour exposure period. The evaluations were made at 24 and 72 hours after application.
GLP compliance:
no
Remarks:
Prior to GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The justification for read-across is attached in Section 13 of the IUCLID.

- Name of test material (as cited in study report): Schercemol 1818, Isostearyl Isostearate
- Lot/batch No.: L#121-225
Specific details on test material used for the study:
Date

Test animals

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

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
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:
3
Details on study design:
The intact and abraded skin of 3 rabbits was used. The hair was clipped from the backs of the rabbits using angora clippers. Four areas of the back, places ca. 10 cm apart were designated for the patches. Areas 2and 3 were abraded by making four epidermal incisions (two perpendicular to two others in the area of the patch). The patches consisted of layers of light gauze cut in aquares (2.5 cm sides). The patches were secured to the area by thin bands of adhesive tape. The material was introduced (0.5 mL) beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands. The test material and control, if using, were applied so that there were two applications to each of 3 animals (one intact, one abraded). The animals were immobilised for the 24 hour exposure period. The evaluations were made at 24 and 72 hours after application.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Intact skin only
The test material elicited a very slight erythema response in two animals at the 24-hour observation which had fully reversed by the 72-hour observation. No other irritation responses were noted.

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not a skin irritant in rabbits.
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 3 rabbits was used. The hair was clipped from the backs of the rabbits using angora clippers. Four areas of the back, places ca. 10 cm apart were designated for the patches. Areas 2and 3 were abraded by making four epidermal incisions (two perpendicular to two others in the area of the patch). The patches consisted of layers of light gauze cut in aquares (2.5 cm sides). The patches were secured to the area by thin bands of adhesive tape. The material was introduced (0.5 mL) beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands. The test material and control, if using, were applied so that there were two applications to each of 3 animals (one intact, one abraded). The animals were immobilised for the 24 hour exposure period. The evaluations were made at 24 and 72 hours after application and scored according to the Draize scheme.

Results

A single 24-Hour, occluded application of the test item to the intact skin of three rabbits produced a very slight erythema response in two animals at the 24-hour observation which had fully reversed by the 72-hour observation. No other irritation responses were noted.

Conclusion

The substance is not a skin irritant in rabbits.