Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Principles of method if other than guideline:
The animals were maintained on appropriate commercial diet and municipal water. Both are available ad libitum except during periods of fasting or manipulation. Dosage levels for the toxicity tests normally differ by a factor of 2 in a geometric series, but may differ by other constant factors if required. The maximum dosage for the peroral and percutaneous tests is 16 ml/kg. Dosages are reduced until significant signs of toxicity are not observed. LD50's and the estimated LD50 slopes are calculated by the moving average method (Thompson, 1947; Weil, 1983) and are based on
a 14-day observation period. Animal weights are recorded at 0 days (before dose), 7 days and 14 days (just prior to sacrifice). At death or sacrifice, each animal is subjected to gross pathologic evaluation.

Peroral Intubation:
Sprague-Dawley albino rats, weighing between 200 and 300 g, receive the test material by stomach intubation with a ball- end stainless steel needle. The sample is injected through the needle by means of a syringe and doses are varied by adjusting the volume of the test material or its dilution.
The rats are fasted overnight before dosing. Five males and five females are included in each level used for LD50 calculations.
GLP compliance:
not specified
Test type:
fixed dose procedure
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:
corn oil
Doses:
25% (w/v) suspension in corn oil. Because of large dose volumes required, doses were divided into 2 portions and administered approximately one hour apart.
Applied doses were 16 g/kg for females and 8 and 16 g/kg for males.
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No animals died in any dose group.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Critieria used; EU
Conclusions:
There were no deaths in male and female rats at 16000 mg/kg.