Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From December 20th, 2001 to 29th January, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted testing guidelines. Some details about testing procedures and test conditions are missing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

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 22 March 1996
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
not specified
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Sprague-Dawley Crl:CD (SD) IGS BR rat (SPL Standard Test Method 512.08).
Fasted before treatment.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
The test material was administered orally as a suspension in distilled water.
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
Three fasted females followed by a group of three fasted males.
Details on study design:
Clinical signs and bodyweight development were monitored during the study.
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.
Mortality:
There were no deaths.
Clinical signs:
Red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted.
Gross pathology:
No abnormalities detected.

Any other information on results incl. tables

Individual Bodyweights and weekly Bodyweight changes

Animal Number and Sex Bodyweight (g) at Day Bodyweight Gain (g) During Week
0 7 14 1 2
1-0 Female 218 250 265 32 15
1-1 Female 241 275 302 34 27
1-2 Female 212 230 235 18 5
2-0 Male 239 312 363 73 51
2-1 Male 224 301 350 77 49
2-2 Male 221 291 344 70 53

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 rat > 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. 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 the test material at a dose level of 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 distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. Red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted. Necropsy did not reveal any abnormalities.

Conclusion

LD50 rat > 2000 mg/kg bw