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Acute Toxicity: dermal

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acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 July 1980 - 20 Oct 1980
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
Test material consisted of the following:96.52% nitroethane0.01% nitromethane3.38% 2-nitropropane0.022% water

Test animals

New Zealand White
Details on test animals or test system and environmental conditions:
According to the protocol:Strain : New Zealand ablino whiteSex: Equal number male and femaleSource: Kelley's. Rabbitry, Laconia , IndianaAge/Weight: At least 9 weeks/2 kgIdentification: Individually numbered on the inner side of the ear pinna,Housing: Individually caged during and after exposureQuarantine: At least 7 days

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
The test was conducted on ten rabbits (5 males and 5 females) weighing 2.7+/-0.2 kg. The animals' abdomens were shaved free of hair, and the skins in all the animals were further prepared by abrasions. The abrasions were made with a blunt hypodermic needle without obtaining bleeding and wereplaced 2-3 cm apart over the area of exposure, Each animal was treated with 2000 mg of liquid P-1355 per kg of body weight.For each rabbit, a weighed amount of P-1355 to give an appropriate dose per kg body weight, was spread over the prepared abdominal skin area. The skin area was then covered with a gauze and a sheet of impervious rubberized cloth to prevent any loss of the test material. The trunk was then further enclosed with a flexible stainless steel protective screen held in place by tape. The animals were then returned to their individual cages. After 24 hours of dermal exposure the bindings and patches were removed. The exposed areas were gently cleaned and observed for skin irritancy.
Duration of exposure:
24 hours
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
Following removal of the wrap and cleaning the application site, the animals were returned to their individual cages and observed daily thereafter for another 14 days for any unusual signs of toxicity or death. At the end of 14 days, the surviving animals were weighed, sacrificed and examined for gross pathology.
According to the protocol, the dermal LD50 value, slope,. and 95% percentile confidence limits were estimated by the method of Finney (Probit Analysis. Cambridge Press 1979), adapted to BASIC computer program.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Dose descriptor:
Effect level:
2 000 mg/kg bw
Based on:
test mat.
All animals survived the 24 hour exposure period and the 14 day observation period.
Clinical signs:
At the end of 24 hours of exposure, the treated skin sites in all the rabbits were normal..The animals showed no signs of toxicity or abnormal pharmacological behavior during the 14 day observation period.
Body weight:
The Mean and Standard Deviation for male rabbits was 2.602 +/- 0.176, 2.631 +/- 0.231 and 2.893 +/- 0.200 kg on study day 0, 7 and 14, respectively. The Mean and Standard Deviation for female rabbits was 2.859 +/- 0.136, 2.911 +/- 0.199 and 3.135 +/- 0.125 kg on study day 0, 7 and 14, respectively.
Gross pathology:
At necropsy, the treated skin sites were normal and a part of the treated skin site from each rabbit was excised and fixed in neutral formalin. The internal organs in all the rabbits were grossly normal.
Other findings:
No additional information available.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Migrated information
All rabbits survived 24 hour exposure to 2000 mg/kg nitroethane as well as a 14 day observation period.
Executive summary:

The dermal toxicity of nitroethane was examined. All rabbits survived 24 hour exposure to 2000 mg/kg nitroethane as well as a 14 day observation period.