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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
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:
1981

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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
A certificate of analysis supplied with the report 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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals: The animals were at least 6 weeks old and weighed 199 +/- 15 g. They were acclimated for at least 4 days before use. The animals were given food and water ad libitum (with the exception that food was withdrawn the night before dosing). The animals were randomly allocated to groups of 10/sex.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: The test material was suspended in 1% carboxymethyl cellulose.
Details on oral exposure:
The maximum dosing volume did not exceed 5 ml per animal.
Doses:
0, 290, 360, 450 and 570 mg/kg
No. of animals per sex per dose:
10/sex/dose
Control animals:
yes
Details on study design:
Test conduct: The test material was administered by gavage at doses of 0, 290, 360, 450 and 570 mg/kg to groups of 10 animals per sex. The maximum dosing volume did not exceed 5 ml per animal. The animals were observed at least daily for 14 days. Animals were weighed before dosing and on days 7 and 14. Animals that died during the study and those that were terminated on day 14 were necropsied.


Statistics:
Based on the mortality rate at the different dose levels, the oral LD50 value, 95% confidence limits, slope and standard error were calculated according to the method of Finney (probit analysis, Cambridge Press, 1979) adapted to a BASIC computer program.

Results and discussion

Preliminary study:
None
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
528 mg/kg bw
95% CL:
472 - 669
Sex:
female
Dose descriptor:
LD50
Effect level:
484 mg/kg bw
95% CL:
441 - 534
Sex:
male/female
Dose descriptor:
LD50
Effect level:
506 mg/kg bw
Mortality:
None of the controls or rats exposed to concentrations <= 360 mg/kg died. Three animals/sex died after exposure to 450 mg/kg and 6/10 males and 9/10 females died after exposure to 570 mg/kg. The deaths occurred within 36 hours of treatment. Postmortem examinations of these animals showed distended and hemorrhagic intestines.
Clinical signs:
One female treated with 570 mg/kg exhibited convlusions before death and two others in the group exhibited ataxia.
Body weight:
Weights of males and females treated with 570 mg/kg appeared to be lower than controls on days 7 and 14. Weight gains in this group appeared to be lower than control from days 0-7, but not from days 7-14.
Gross pathology:
Postmortem examinations of early deaths(see mortality section) showed distended and hemorrhagic intestines.

Three, one, five, and one surviving animal(s) exposed to 290, 360, 450 and 570 mg/kg (respectively) had evidence of lung infection at termination. All females and all other males that survived to termination had normal pathology.
Other findings:

The LD50 value (with the 95% confidence interval) and slope of the line for males was 528 (472-669) mg/kg and 11.3 +/- 3.8, respectively. The LD50 value (with the 95% confidence interval) and slope of the line for females was 484 (441 - 534) mg/kg and 18.9 +/- 5.6, respectively. The LD50 value for both males and females was 506 mg/kg.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information not classified as toxic Criteria used for interpretation of results: other: EU GHS
Conclusions:
The LD50 value (with the 95% confidence interval) and slope of the line for males was 528 (472-669) mg/kg and 11.3 +/- 3.8, respectively. The LD50 value (with the 95% confidence interval) and slope of the line for females was 484 (441 - 534) mg/kg and 18.9 +/- 5.6, respectively. The LD50 value for both males and females was 506 mg/kg.
Executive summary:

None