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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:
21 Oct 1980 - 23 Oct 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material contained 95.88% nitromethane, 3.31% nitroethane, 0.55% 2-nitropropane and 0.023% water by weight. Additional minor impurities were not identified.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Rabbits were at least 9 weeks of age and weighed 2 kg. Rabbits were individually caged during and after exposure. Rabbits were quarantined for at least 7 days. Animals were fed Purina Certified Rabbit Chow #5322 and water ad libitum. The diet was certified free of contaminants and the analysis was performed by the supplier. Every quarter the animals' drinking water was analyzed to ensure that the levels of contaminants were equal to or less than the recommended levels as per the Primary Drinking Water Regulations (40 CFR 141.11, 141.12, 141.14).

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
4, 24 and 48 hours after application of the test material.
Number of animals:
6
Details on study design:
To a hair free area on the back, the test material was applied under a 1 inch square gauze patch and then with an impervious rubberized cloth. The test material was applied to a single intact skin site per rabbit. The test material was left in contact with the skin for four hours. After exposure, the skin sites were wiped clean and left exposed to the air for the duration of the study. The treated skin site was visually examined for erythema, edema or any irreversible tissue destruction at 4, 24 and 48 hours after the inital application of the material. Skin reactions of erythema, edema or tissue destruction was noted and reported. Any tissue destruction was scored as a positive reaction (according to Draize, Association of Food and Drug Officials of the United States, p 48, 1959). Body weights were measured and recorded at 0 and 48 hours after exposure. Any animals which died during the test were necropsied and examined for tissues or organ damage. At 48 hours after the skin site examination, the animals were sacrificed by intravenous administration of benzyltrimethylammonium chloride.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 hr
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 hr
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Nitromethane was not irritating to the skin
Other effects:
Day 0 mean body weight was 2.789 +/- 0.127 kg while day 2 mean body weight was 2.826 +/- 0.118 kg.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Nitromethane was not irritating when applied to the skin.
Executive summary:

The dermal irritation potential of nitromethane was examined with rabbits. Nitromethane was not irritating to the skin of rabbits.