Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 17th to February 05th, 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

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)
Version / remarks:
adopted 22 March 1996
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:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study:
yes; animals were dosed fasted.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
BP
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Three females and three males
Details on study design:
Clinical signs and bodyweight development were monitored during the study.
All animals were subjected to gross necropsy examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No deaths occurred.
Clinical signs:
No signs of toxicity were noted during the study.
Gross pathology:
No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
LD50 (male and female) > 2000 mg/kg bw
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley Crl:CD (SD) IGS BR rat. The method followed the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996), EU Commission Directive 96/54/EEC Method B1 tris Acute Oral Toxicity (Oral Acute Toxic Class Method).

A group of three fasted females was treated with 2000 mg/kg bodyweight; this was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy examination.

No deaths occurred and signs of toxicity were noted during the study. Individual necropsy did not revealoed any abnormality.

Conclusion

LD50 (male and female) > 2000 mg/kg bw