Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
march to june 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study by a laboratory having a GPL certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate on october 1st 2008
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
300 and 2000 mg/kg under a dose-volume of 10 mL/kg.
No. of animals per sex per dose:
Three groups of three female rats each were treated at the dose-level of 300, 2000 and 2000 mg/kg
Control animals:
yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No death or clinical signs were observed during the study.
Clinical signs:
No apparent abnormalities were observed in any animal
Body weight:
A body weight gain was noted between day 1 and day 8 in 3/6 females given 2000 mg/kg (29,27 and 29 g respectively) and between day 8 and day 15 in 1/3 females given 300 mg/kg (6 g). The body weight gain of other animals was not affected by treatment .

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the classification criteria laid down in concil Directive 67//548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, concerning the potential toxicity by oral route, the test item Urethane Resin M2001 should not be classified.