Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
yellow liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Source: DEPRE or IFFA CREDO
weight: about 250 g at the time of the trial
Acclimatation: at least 7 days in the animal selter of the laboratory were the trial is carried out
Housing: the animal are kept in individual polystyrene cages of standardized dimensions with perforated floor. These cages are places in a temperature controlled animal shelter where the temperature is 22°C+-3°C and the relative humidity is maintained between 30 and 75%
the air is filtered and evacuated.
Food: aliment A04, UAR - VILLEMOISSON - 91360 EPINAY SUR ORGE
Water: tap water provided ad libitum in sterilizable makrolon bottles equiped with stainless steel pipettes.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test item was administrated with the syringe and the gastro-esophageal probe at the chosen dose of 2 g/kg body weight, according to study report.
Doses:
2 g/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
The animals were observed regularly on the day of administration (immediately, within 15 minutes after gavage and 6h after administration) and then at least once a day for 14 days.
The various parameters observed were: Apathy, Excitation, Palpebral ptosis, sleeping, comas, tembling, convulsions, refusal of food or drink, modification of volume or appearance of feces or urines, mouth, anal ou nasal bleeding and mortality.
Animals were weighed on D0, D7 and D14.
Statistics:
none

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not classifÌed based on a LD50 higher than 2000 mg/kg bw and no toxic effects observed at that dose level.
Executive summary:

The test item was administered to a group of 5 males and 5 females Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 401.

No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight.

In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.