Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

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)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Lot/batch No.: 110825
Expiration date: August 25, 2014
Purity: 100%

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Test animals: Crl:WI (Charles River, Germany)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 * 3 rats
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no
Clinical signs:
0.5 - 4 hrs after dosing piloerection was noted in all 6 rats. In addition, all 6 rats showed a hunched posture 2 hrs after dosing. 6 hrs after dosing and from days 1-14 all rats were free of any abnormalities.
Body weight:
No adverse effects observed
Gross pathology:
No adverse effects observed

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The oral LD50 is > 2000 mg/kg bw
Executive summary:

The acute oral toxicity of the test item was examined in female Wistar rats in a study according to OECD Guideline 423 with GLP compliance. Apart from piloerection and hunched posture seen 0.5 - 4 hrs after dosing no other adverse effects were reported. The oral LD50 was > 2000 mg/kg bw.