Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes (incl. certificate)
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: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg body weight (bw)
No. of animals per sex per dose:
5 male-, 5 female rats
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Any other information on results incl. tables

There were no mortalities.

Slight to moderate hair loss was noted in all female animals from either Study Day 2 or 3 until Study Day 15. No treatment-related clinical signs of toxicity were observed in male animals.

The mean body weight gain in females was slightly reduced compared to background control data. There was no treatment-related effect on body weight gain in males.

No abnormalities of the thoracic and abdominal viscera were observed.

The acute oral LD50 value of the test substance in both male and female rats was greater than 2000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It was concluded that 1, 1 diphenylethylene (AE C512947 PC11631MC), was of low acute oral toxicity to the rat.