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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
SPF-bred Wistar rats of the strain Clr:(WI)BR
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: about 10 weeks
- Fasting period before treatment: overnight (maximal 20 h)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
Clinical signs as lethargy, hunched posture, laboured respiration, rales, piloerection, uncoordinated movements, and/or chromodacryorrhea were noted among the animals between days 1 and 7.
Body weight:
no effects on weight gain
Gross pathology:
no abnormal findings
Other findings:
none

Any other information on results incl. tables

Dose (mg/kg bw) Toxicological results  Onset and duration of signs  Onset of mortality
2000 0 / 3 / 3 --- --- 
2000 0 / 3 / 3 --- --- 

Toxicological results:

number of dead animals / number of animals with clinical signs after treatment / number of animals treated

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of the test item was evaluated in a GLP-compliant study on male and female Wistar rats according to OECD TG 423. The oral dose of 2000 mg/kg bw was tolerated without mortalities, effects on weight gain or gross pathological findings. Clinical signs as lethargy, laboured respiration, piloerection, and/or chromodacryorrhea were noted among the animals between days 1 and 7. The LD50 was determined with > 2000 mg/kg bw.