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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:
15 Mar - 05 Apr 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2004
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
adopted in 2002
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
HsdCpb:Wu
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2% Cremophor EL
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females per step
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: cut-off value
Mortality:
No mortality occurred during the study period.
Clinical signs:
Clinical signs were observed in all animals and comprised decreased motility in 6/6 rats, uncoordinated gait in 6/6 rats, piloerection in 5/6 rats, abdominal position in 5/6 rats, labored breathing in 1/6 rats and increased water intake in 6/6 rats. All effects were fully reversible until study Days 8 (first dosing step) and 9 (second dosing step).
Body weight:
All animals gained weight as expected.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
Oral administration of 2000 mg/kg bw test substance did not induce mortality in female rats. Clinical signs of toxicity were observed in all animals and comprised decreased motility, uncoordinated gait, piloerection, abdominal position, labored breathing and increased water intake. There was no impairment of body weight development and no gross and histopahtological abnormalities. The LD50 value was > 2000 mg/kg bw. No classification is required according to CLP/EU GHS criteria.