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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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

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