Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06.07.2010 - 27.07.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2010

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)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg b.w. and 300 mg/kg b.w.
No. of animals per sex per dose:
2000 mg/kg: 3 females
300 mg/kg: 6 femals
Control animals:
no
Details on study design:
The test item was administered in a first step to a group of 3 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight and in a second step to a group of 6 female Spague Dawley rats at the single dose of 300 mg/kg body weight

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
It was noted the death of 3 rats treated at 2000 mg /kg b.w. at 3 hours (2/3) and at 23 hours 50 minutes post-dose (1/3).
No mortality occurred in the animals treated at 300 mg/kg b.w.
Clinical signs:
The mortalities were preceded by a decrease in spontanous activity (2/3), in Preyer's reflex (2/3), in body temperature (2/3) and in muscle ton (2/3), a bradypnea (1/3), a mydriasis (2/3), tremors (1/3), a partial ptosis (1/3) and an increases lachrymation (1/3).
No clinical signs related to the administration of the test item at 300 mg/kg b.w. were observed. Indeed, only a decreas in spontaneous activity was noted in one animal (1/6) at 3 hours post-dose. The animal recovered a normal behaviour at 24 hours post-dose.
Body weight:
A decrease was noted on the body weight of the animal that died at 23 hours 50 minutes post-dose: -7% compared to day 0.
Treatment at 300 mg/kg b.w.: The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
Treatment at 2000 mg/kg b.w.: The macroscopical examination of the dead animals revealed a thinning of the forestomach (3/3), associated with a white coloration (2/3), red spots on the corpus (2/3) and a white thinning of the corpus (1/3).
Treatment at 300 mg/kg b.w.:: The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
in conclusion, the LD50 of the test item is higher than 300 mg/kg body weight and lower than 2000 mg/kg body weight by oral route in the rat.
In accordance with the OECD guideline No 423, the LD50 cut off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.