Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP Study, but sufficiently documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 11 000 mg/kg bw
Sex:
male
Dose descriptor:
LDLo
Effect level:
ca. 11 000 mg/kg bw

Any other information on results incl. tables

The test item was administered as a single oral dose by intragastric intubation to male rats at doses of 670, 2300, 3400, 5000, 7500, or 11,000 mg/kg. Following dosing, the rats were weighed and observed for mortality and clinical signs of toxicity over a 14-day observation period. No deaths occurred. The rats dosed at 670, 2300, 3400, or 7500 mg/kg exhibited no clinical

signs of toxicity or body weight loss during the study. The rat dosed at 5000 mg/kg exhibited lung noise on the day of dosing and yellow-stained perineum up to 4 days after dosing. Low posture, brown oral discharge, partially closed eyes, lethargy, lung noise, and yellow-stained perineum were observed by 4 days after dosing in the rat dosed at 11,000 mg/kg. Body weight

loss of approximately 15 or 21% of initial weight occurred by 3 or 4 days after dosing in the rats

dosed at 5000 or 11,000 mg/kg.

Under the conditions of this study, the oral ALD for the test item was greater than 11,000 mg/kg of

body weight. This substance is considered to be very low in toxicity (ALD greater than

5000 mg/kg) when administered as a single oral dose to male rats.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU