Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 November 2008 - 11 December 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): OS238132
- Physical state: tan colored solid
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Doses:
1
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
mg/kg bw
Remarks on result:
other: no deaths
Mortality:
No deaths
Clinical signs:
No sings of systemic toxicity
Body weight:
All animals showed expected gains in bodyweight
Gross pathology:
No abnormalities were noted at necropsy

Any other information on results incl. tables

The acute oral median lethal dose (LD50)of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified).
Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat according to OECD Guideline No 420 and Method B1 Acute Toxicity (Oral) of Commission Directive 2004/73/EC. Following a sighting test at adose level of 2000 mg/kg,an additional four fasted female animals were given a single oral dose of test material, as a suspension in dimethy! sulphoxide, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths and no signs of systemic toxicity. All animalsshowed expected gains inbodyweight. No abnormalitieswere noted atnecropsy. The acute oral median lethal dose (LD50)of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified).