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:
November 18, 1976 - December 29, 1976
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
The method employed 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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: The method employed 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.
Deviations:
not specified
Principles of method if other than guideline:
A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma t o produce bleeding.
The skin of the other side was allowed to remain intact . A 0.5 ml portion of material 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 o f the animals t o hold the patches i n place.
The wrapping was removed a t the end o f the twenty-four hour period and the treated areas were examined. Readings were also made after seventy-two hours. The Draize method of scoring was employed.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
DABCO TMR-2

Test animals

Species:
rabbit
Strain:
not specified
Remarks:
Albino

Test system

Type of coverage:
occlusive
Preparation of test site:
other: One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
both intact and abraded skin sections
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
both intact and abraded skin sections
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
both intact and abraded skin sections
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
both intact and abraded skin sections
Irritant / corrosive response data:
No indications of irritation on both intact and abraded skin sections in all animals.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The tested product is not a primary irritant on intact or abraded rabbit skin at applied concentrations of 0.5 ml undiluted test material, occluded for 24 hours.