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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
Study period:
From Feb. 20, 1979 to Feb. 23, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, comparable to scientific standards/principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study was performed to determine the skin irritation potential of test substance on the rabbit skin. The aqueous slurry of test substance was applied to the shaved skin and the irritation potential was determined.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: N,N-Bis(2-Hydroxyethyl)-p-phenylenediamine sulfate
No other information on the test substance was provided in the study report.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
EXPERIMENT INITIATION DATE: Feb. 20, 1979

EXPERIMENT COMPLETION DATE: Feb 23, 1979
No details on test animals and environmental conditions were provided in the study report.

Test system

Type of coverage:
not specified
Preparation of test site:
other: shaved intact and abraded skin
Vehicle:
other: aqueous slurry of test substance
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 500 mg (aqueous slurry)
- Concentration: Undiluted
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 h after treatment
Number of animals:
Shaved intact skin: 6 animals (4 female and 2 male)
Shaved abraded skin: 6 animals (4 female and 2 male)
Details on study design:
TEST SITE: The test site was shaved. No other information on test site was provided in the study report.

REMOVAL OF TEST SUBSTANCE: No details on the removal of test substance are provided in the study report.

SCORING SYSTEM: The irritation index used to classify the test substance was as follows:
0-2………………………………Mild irritant
2.1-4.9………………………..Moderate irritant
5-8……………………………… Severe (primary skin irritation) irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0
Reversibility:
other: No erythema observed
Remarks on result:
other: On the both shaved intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0
Reversibility:
other: No edema observed
Remarks on result:
other: On the both shaved intact and abraded skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
- No signs of irritation were observed in any of treated animals (shaved intact and abraded skin) during the study period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
expert judgment
Conclusions:
Application of undiluted N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate to rabbit’s shaved intact and abraded skin did not produce skin irritation. The test substance was classified as non-irritant to rabbit skin.
Executive summary:

The purpose of this in-vivo skin irritation test was to evaluate skin irritation potential of N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate when applied to rabbit’s shaved intact and abraded skin.

6 rabbits (4 female and 2 male) were used in each treatment group (shaved intact and abraded skin). 500 mg of test substance was applied to the test site of each rabbit.

The treated skin site was observed for edema and erythema for 24 h and 72 h after treatment.

No signs of irritation were observed in any of the treated animals (shaved intact and abraded skin) during the study period.

Based on above, application of undiluted N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate to rabbit’s shaved intact and abraded skin did not produce skin irritation. The test substance was classified as a non-irritant to rabbit skin.