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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:
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:
reference to same study
Reason / purpose:
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 type:
standard acute method
Limit test:
yes

Test material

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

An analytical report submitted with the sample 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:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
The animals were at least 9 weeks old and weighed 2.6 +/- 0.3 kg. They were acclimated for 7 days before use. Twenty four hours before the test, each animal was examined. Only animals with no skin injury were used. The animals were given food and tap water ad libitum.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The abdomens of all 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, 4,4 - 5.7 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.
Duration of exposure:
24 hours
Doses:
single 2000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
The test was conducted on ten rabbits (5 males and 5 females) weighing 2.6 - 2.03 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 were
placed 2-3 cm apart over the area of exposure. Each animal was treated with 2000 mg of P-1357 per kg of body weight. The 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 their individual cages. After 24 hours of dermal exposure the bindings and patches w ere 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. t the end of 14 days, the surviving animals were weighed, sacrificed and examined for gross pathology.


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.
The 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:
None

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None of the animals died.
Clinical signs:
None of the animals exhibited signs of toxicity.The treated skin sites did not exhibit any erythema or edema after 24 hours of treatment.
Body weight:
Body weight gains were normal.
Gross pathology:
Gross necropsies of the animals were normal.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category V
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
The LD50 in rabbits is >2000 mg/kg and not classified as toxic.
Executive summary:

None