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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 1997/02/13 to 1997/02/27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No deviation occured in this study. This tudy was conduced according to OECD 401 guideline in compliance with Good Laboratory Practices.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Substance tested for the read-across
Identification: Montanov 14, batch 1292MP
Appearence: white flakes
Laboratory reference: 07-0283
Storage: at room temperature, away from the light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Test system:
- Supplier: IFFA-CREDO (69210 - L'ARBRESLE, FRANCE)
- Age, weight: about 6 weeks, weight between 186 g and 209g (males) and 165 g and 173g (females)
- Acclimatization: at least 5 days
- Housing, diet: 5 animals by sex in polypropylene cages (310*465*190) in accordance with the requirements of the 86/609/EEC guideline. Complete pelleted rat maintenance diet UAR A04-10 (91360 - Epinay sur Orge, France)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
Animals have been fasted prior to substance administration by withholding food overnight. They receive by gavage, according to the bodyweight, the product diluted in distilled water (Meram batch 62417), previously heated at 80°C, at the single dose of 2000mg/kg under a constant volume of 10 mL/kg. The preparation is kept up under magnetic stirring till obtaining a homogeneous mixture, to ambient temperature.
Doses:
2000mg /kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observations:
The animals are observed daily for 14 days after the treatment
- Clinical examinations
A clinical observation is carried out at least once a day in order to evaluate the general appearence, the behaviour and vegetative functions of the animals. An individual clinical observation is realized one hour after treatment. The continous observations during the five following hours are renewed each following day.
Body weight are taken just prior the test material administration (D1) and again on days 4, 8 and 15.
- Macroscopic examinations
At terminaison of the 14 days observation days, the rats are sacrified after barbituric anaesthesia, then autopsied. All abnormalities are recoded.
No tissue is saved.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The test item does not cause any death.
Clinical signs:
The test item has no significant toxic effect on the animals' behaviour or vegetative functions.
Body weight:
the test item does not modify their weight growth.
Gross pathology:
The test item does not cause any gross lesion visible at autopsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under hte experimental conditions adopted, oral LD0 of the test preparation is higher than 2000mg/kg in the rat.
Executive summary:

Study Objective

To estimate the potential for toxicity and lethality of a single dose level of a test substance in the rat.

Regulatory compliance

This tudy was conduced according to OECD 401 guideline in compliance with Good Laboratory Practices.

Experimental procedure

The test item was administred to 10 albnino rat, Sprague Dawley OFA (5 males and 5 females) at the dose of 2000mg/kg body weight.

Animals have been fasted prior to substance administration by withholding food overnight. They receive by gavage, according to the bodyweight, the product diluted in distilled water (Meram batch 62417), previously heated at 80°C, at the single dose of 2000mg/kg under a constant volume of 10 mL/kg. The preparation is kept up under magnetic stirring till obtaining a homogeneous mixture, to ambient temperature.

Observation

The test item does not cause any death.

The test item has no significant toxic effect on the animals' behaviour or vegetative functions.

the test item does not modify their weight growth.

The test item does not cause any gross lesion visible at autopsy.

Conclusion

Under the experimental conditions adopted, oral LD0 of the test preparation is higher than 2000 mg/kg in the rat.

According to 67/548/EEC directive, the test preparation is unclassified if swallowed.