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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:
1980/06/18-1980/11/24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This non-GLP study was not conducted under OECD 401, however the reported data is similar enough not to warrant restriction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
QA inspected 1980/07/10 and signed off 1980/11/11
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material was stored in the original container in a ventilated metal cabinet (22 °C)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Rats supplied by King Animal Labs were housed 3/cage in suspended stainless steel cages prior to treatment and singly housed thereafter. Animal rooms were maintained at 22 °C, 40% humidity, and a 12 h light cycle. Purina Rodent Chow 5001 and water were available ad libitum except for 18 h prior to dosing. Apparently healthy rats between 60-95 g were selected for the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Dose Volume 15 ml/kg
Doses:
1500, 1825, 2221, 2702, 3288 and 4000 mg/kg
No. of animals per sex per dose:
10/sex
Control animals:
no
Details on study design:
A single dose of the undiluted test material was administered intragastrically to ten fasted (over night) male and female rats at each treatment level. (Thirteen females were inadvertently dosed in Group 3 and seven females were dosed in Group 4.) A control group was not included. The animals were observed for signs of toxicity or behavioral changes daily. Individual weights were recorded on the day of dosing, and at termination. All animals were euthanized at the conclusion of the observation period. Gross autopsies were performed on all animals after 14 days.


Statistics:
Estimation of LD50 by means of logarithmic-probit according to Miller and Tainter (1944)

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
3.1 other: g/kg
95% CL:
2.6 - 3.8
Sex:
male
Dose descriptor:
LD50
Effect level:
3.2 other: g/kg
95% CL:
3.6 - 4
Mortality:
Deaths occurred in all groups greater than 1825 mg/kg within 93 hours of dosing.


Clinical signs:
Signs of toxicity included hypokinesia at all dose levels, ataxia at doses above 1825 mg/kg and diarrhea in almost all animals in all dose groups.

Body weight:
All surviving animals gained weight.

Gross pathology:
Necropsy findings in animals that died on test were limited to findings suggestive of post mortem changes. No treatment related necropsy findings were observed. Surviving animals had no remarkable necropsy findings.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test article, when administered as received in corn oil to male and female Sprague-Dawley rats, had an acute oral LD50 of 3.2 (2.6-4.0) g/kg (males); 3.1 (2.6-3.8) g/kg (females).
Executive summary:

In an acute oral toxicity study, male and female Sprague Dawley rats were exposed to test substance at doses of 1500, 1825, 2221, 2702, 3288 and 4000 mg/kg. The oral LD50 is 3200 mg/kg in male and 3100 mg/kg in female rats. Sublethal effects of hypokinesia and diarrhea were observed in all groups. Necropsy observations were unremarkable. Based on the results of this study, the test substance would be classified as Category 5 in accordance with the classification system of GHS. This toxicity study is classified as acceptable and satisfies the guideline requirement for acute oral toxicity in rats.