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Administrative data

Description of key information

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

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Reference:
Composition 0
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 information:
Composition 1
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.
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.
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.
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

ACUTE TOXICTY BY ORAL ROUTE

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 423 and the EU Method B1 tris. 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 of 2000 mg/kg bw. No deaths occurred and signs of toxicity were noted during the study. Individual necropsy did not revealoed any abnormality.

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

In conclusion, the test substance does not meet the criteria to be classified for oral acute toxicity, according to the CLP Regulation (EC) No 1272/2008.