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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No data on GLP, comparable to a guideline, limit study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test was conducted using 10 rabbits weighing 2.8 +/- 0.1 kg, The animals were divided into two groups of five each (five males and five females ) . The abdomens of all the animals were shaved free of hair, and the abdominal skin of all the animals were further prepared by abrasions, The abrasions were made with a blunt hypodermic needle without obtaining bleeding and were placed 2-3 cm apart over the area of exposure.
All the animals were treated with 2000 mg of 1-nitropropane/kg of body weight.
A weighed amount of P-1356, 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 prevent loss of the test material. The trunk was further enclosed with a flexible stainless steel protective screen held in place by a tape. The animals were then returned to their individual cages. After 24 hr of dermal exposure, the bindings and patches were removed. The exposed areas were gently cleaned and observed for skin irritancy. The animals were returned to their cages and were 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.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The analytical report submitted with the sample indicated that the purity of the test material was 96.12%. The test material also contained (by weight) 2.44% 2-nitropropane, 0.64% 1-nitro-2-methyl propane, 0.42% 2-nitrobutane, 0.35% 2-nitro-2-methyl propane, and 0.013% water. Other minor impurities were not listed.

Test animals

Species:
rabbit
Strain:
other: The strain of rabbit used was not listed. However, other dermal toxicity studies performed by this laboratory at approximately the same time were performed on New Zealand white rabbits. Therefore, it is likely that this strain was used in this experimen
Sex:
male/female
Details on test animals and environmental conditions:
Body weights: 2.8 +/- 0.1 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The abdomens of all the animals were shaved free of hair, and the abdominal skin was abraded. The abrasions were made with a blunt hypodermic needle (without producing bleeding) and were placed 2-3 cm apart. Test material (2000 mg/kg, 5.1 - 6.0 ml) was spread over the shaved area of all rats. The skin area was then covered with gauze and a sheet of impervious rubberized cloth. The trunk was further enclosed with a flexible stainless steel protective screen held in place by tape.


Duration of exposure:
24 hours
Doses:
2000 mg/kg, 5.1-6.0 ml
No. of animals per sex per dose:
4 males and 5 females /dose
Control animals:
no
Details on study design:
The animals weighed 2.8 +/- 0.1 kg. The test was conducted in 2 parts. The first test was conducted on one male rabbit and the second on four males and five females. The abdomens of all the animals were shaved free of hair, and the abdominal skin was abraded. The abrasions were made with a blunt hypodermic needle (without producing bleeding) and were placed 2-3 cm apart. Test material (2000 mg/kg, 5.1 - 6.0 ml) was spread over the shaved area of all rats. The skin area was then covered with gauze and a sheet of impervious rubberized cloth. The trunk was further enclosed with a flexible stainless steel protective screen held in place by tape. The dressings were removed after 24 hours. The sites were cleaned and examined for erythema and edema. The animals were observed for toxicity over 14 days. Body weights were recorded prior to application of material and at 7 and 14 days. Gross necropsies were performed on all rabbits euthanized on day 14.

If possible, LD50 value, slope and 95% confidence limits were calculated using the probit analysis of Finney (Cambridge Press, 1979) adapted to a BASIC computer program.
Statistics:
If possible, LD50 value, slope and 95% confidence limits were calculated using the probit analysis of Finney (Cambridge Press, 1979) adapted to a BASIC computer program.

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All of the animals survived the 14 day observation period.
Clinical signs:
The treated skin sites exhibited no erythema or edema after 24 hours of treatment with test material. None of the animals had any signs of toxicity.
Body weight:
Body weight gains were normal.
Gross pathology:
Gross necropsies of the animals were normal (with the exception of 1 female with a lung infection and another with a neck cyst and a maxillary tumor).
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
other: not classified as toxic
Remarks:
Criteria used for interpretation of results: other: EU GHS
Conclusions:
The dermal LD50 in rabbits is >2,000 mg/kg BW.
Executive summary:

None