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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:
1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, comparable to a guideline study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Comparable to a guideline study
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Production lot batch# 8K14-4A

A certificate of analysis supplied with the report indicated that the purity of the test material was 97.10%. The test material also contained (by weight) 1.01% nitroethane, 2.59% 1-nitropropane and 0.023% water.

Test animals

Species:
rabbit
Strain:
other: albino rabbits
Details on test animals or test system and environmental conditions:
The test was conducted in six albino rabbits weighing 2.4 +/- 0.1 kg.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
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
Details on study design:
The primary dermal irritation test was conducted in six albino rabbits weighing 2.4 +/- 0.1 kg. The skin from the back area of each animal was clipped free of hair. The skin site left of the middorsal line on each rabbit was left intact and the skin on the right side was abraded at 2 sites with a blunt hypodermic needle. The abrasions were minor incisions through the stratum corneum but did not disturb the derma or produce bleeding. A total of 4 sites (2 intact and 2 abraded) were tested per animal.

A 0.5 ml sample of test material was applied to each site and covered with a moistened gauze pad. The entire trunk was then wrapped with a rubberized, impervious cloth and a flexible stainless steel wire screen held in place by tape. The dressings were removed after 24 hours and the treated skin sites were gently cleaned. The skin reactions were scored immediately (24 hr) and 48 hours later (for a total of 72 hours). The irritation index for each rabbit was calculated as a sum of all the scores divided by 4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Irritant / corrosive response data:
All erythema and edema scores at 24 and 72 hours were 0. The material was not irritating.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
other: Not classified, not irritating
Remarks:
Criteria used for interpretation of results: other: EU GHS
Conclusions:
All erythema and edema scores at 24 and 72 hours were 0. The material was not irritating.
Executive summary:

None