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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
We have only an in vivo study, no in vitro study. That is why we are using this in vivo study, in agreement with the requirements for this endpoint.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Nov 1980 - 20 Nov 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted comparable to test guidelines and in accordance with GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
rabbits were tested on intact and abraded skin
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material consisted of:96.52% nitroethane0.01% nitromethane3.38% 2-nitropropane0.022% water

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals and environmental conditions:
The primary dermal irritation test for P-1355 was conducted in six albino rabbits weighing 2.1+/-0.1 kg.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Test site was shaved and test material was applied on intact and abraded skin.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hour
Observation period:
The skin reactions were scored immediately (24 h) and at the end of 72 hr (48 h after the first scoring).
Number of animals:
6
Details on study design:
The skin from the back area of each animal was clipped free of hair. The prepared skin site left of the middorsal line on each rabbit was left intact while the skin on the right side was abraded at two separate places by making minor epidermal incisions in a tic tac toe pattern with a blunt hypodermic needle. The abrasions were minor incisions through the stratum corneum, but not deep enough to disturb the derma or produce bleeding. A total offour sites were treated in each rabbit, two intact and two abraded, with the test material.A 0.5 ml of P-1355, 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. After 24 h exposure, the bindings and the patches were removed and the treated skin sites were gently cleaned. The skin reactions were scored immediately (24 h) and at the end of 72 hr (48 h after the first scoring).

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
Edema and Erythema were scored.
Basis:
mean
Time point:
24 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The maximum score 1 for erythema and edema was found on only one animal and fully reversed within 72 hours.
Irritant / corrosive response data:
At 24 h the compound produced mild erythema and edema (each scored as 1) on the abraded skin sites of one rabbit (#479), the treated skin sites in the other rabbits were normal. The average skin irritation score for the six rabbits for the two observation periods was 0.1.
Other effects:
No additional information available.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Nitroethane (P-1355) was nonirritating to the skin.
Executive summary:

The skin irritation potential of nitroethane was examined. Of the six rabbits tested, there was no irritation observed on intact skin. On abraded skin, only one had erythema and edema observed at the abraded application site at the end of the exposure period. None of the rabbits exhibited irritation 48 hours later. Thus using the criteria of OECD Guideline 404 of testing only intact skin, nitroethane (P-1355) produced no irritation in rabbits.