Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material was administered as a 10% suspension in 0.5% aqueous guar gum

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Rats were housed individually in suspended, stainless steel mesh cages; food & water were available ad lib.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: guar gum, 0.5% in water
Details on oral exposure:
single oral gavage following overnight fast
Doses:
400, 800, 1600, 3200 mg/kg
No. of animals per sex per dose:
4
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 903 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
2 263 mg/kg bw
Based on:
test mat.
Mortality:
4 of 4 male and 4 of 4 female rats died within 24 hours of exposure at 3200 mg/kg; 1 of 4 male and 0 of 4 female rats died within 24 hours of treatment with 1600 mg/kg.
Clinical signs:
Slight to severe weakness, prostration, ataxia, cyanosis, labored breathing, dark eyes and anorexia. All rats treated with either 400 or 800 mg/kg dose level were clinically normal by 2 days after dosing. With the exception of slight weakness and anorexia noted on days 1 and 2, the surviving rats at the 1600 mg/kg dosing level appeared normal on the following day after dosing.
Body weight:
All rats which survived to termination of the study gained weight during both weeks of the study.
Gross pathology:
necropsy was not performed

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: other:
Conclusions:
Based on the oral LD50 calculated from the combined mortality data, the test material was
classified as slightly toxic according to the criteria set forth by Hodge and Sterner (1949) and
requires no toxicity classification as defined in the 18th Adaptation on the EC Classification,
Packaging, and Labelling of Dangerous Substances.
Executive summary:

An acute oral toxicity study was conducted with groups of four male and four female rats administered the test material by gavage. Each animal received a single oral dose of 400, 800, 1600, or 3200 mg/kg of the test material administered as a 10% suspension in a guar gum vehicle. All animals at the 3200 mg/kg dose level and a single male at the 1600 mg/kg dose level died after exposure to the test material. Abnormal clinical signs evident during the study included slight to severe weakness, prostration, ataxia, cyanosis, labored breathing, dark eyes, and anorexia. The abnormal clinical signs were either transient or noted prior to death. All animals at the 400 and 800 mg/kg dose levels were clinically normal by 2 days after dosing. With the exception of slight weakness and anorexia noted on Days 1 and 2, the surviving animals at the 1600 mg/kg appeared clinically normal on the day following dosing. All animals which survived to termination of the study gained weight during both weeks of the study. The cause of death for rats which died after exposure to the test material was not determined. Animals which died following administration of the test material died within 24 hours of dosing and were not necropsied. The acute oral LD50 for this test material was calculated to be 1903 mg/kg for male rats and 2263 mg/kg for female rats. The acute oral LD50, calculated by combining the male and female mortality data, was 2075 mg/kg. Based on the oral LD50 calculated from the combined mortality data, the test material was classified as slightly toxic according to the criteria set forth by Hodge and Sterner (1949) and requires no toxicity classification as defined in the 18th Adaptation on the EC Classification, Packaging, and Labelling of Dangerous Substances.