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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
source of read across approach
Adequacy of study:
key study
Study period:
From January 17th to February 05, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report Date:
2002

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:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Remarks:
distilled water
Doses:
Single oral administration of 2000 mg/kg bw
No. of animals per sex per dose:
3 females
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily; clinical signs and bodyweight development were monitored during the study.
- Necropsy of survivors performed: yes; all animals were subjected to gross necropsy.

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 systemic toxicity were noted during the study.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Other findings:
No abnormalities were noted at necropsy.

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
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 No. 423 and EU Commission Directive 96/54/EEC Method B1 tris Acute Oral Toxicity. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. The treatment 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 dispersion in distilled water. No deaths ocurred; no signs of systemic toxicity were noted during the study. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.

Conclusion

LD50 (males and female) > 2000 mg/kg