Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
FROM 1997-11-27 TO 1997-12-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

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:
- appearence: whitye solid
- Quantity received: 100g in a plastic jar
- Received: 1997-11-10
- Laboratory reference: 97-3691
- Homgeneity test: not required for less than 28 days studies
- Storage: at rrom temperature, away from the light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Supplier: IFFA-CREDO (69210 - L'arbresle, France)
Age, weight: about 6 weeks, weight between 201 g and 207 g (males and 173 g and 175 g (females) at the beginning of the study
Acclimatization: at least 5 days
Housing, diet: 5 animals by sex in polypropylene cages. Complete pelleted rat maintenance diet UAR A04-10 (91360-Epinay sur Orge, France)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Animals have been fsted before prior to substance administration by withholding food overnight. They received by gavage, according to the bodyweight, the product diluted with CMC (carboxymethyl cellulose) at 0.5 % (cooper batch F16539) and homogenised with mortar, at the single dose of 2000 mg/kg under a constant volume of 10 mL/kg. The administrated preparation was kept up under magnetic stirring during the treaments.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
14 days after the exposure, rats were sacrified after barbituric anaesthesia, then autopsied. all abnormailities were recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: >= 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: >= 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No mortality occured
No alteration
Body weight:
individual growth weight normal and regular
Gross pathology:
Effects on organs:
did not show any visible organic or tissular lesions

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the 67/548/EEC directive, the test substance is unclassified among the substances dangerous if swallowed
Executive summary:

The aim of this study was to assess the toxicity of the test item UG after a single oral exoposure of 2 000mg/kg body weight.


The rats were observed up to 14 days after the oral dose.


No mortality occured, no clinical sign was observed, individual growth weight of the rats remain normal and regular.

Effects on organs: did not show any visible organic or tissular lesions


Lethal Dose 0% (LD0) of the test substance is higher than 2000 mg/kg body weight.

According to the 67/548/EEC directive, the test substance is unclassified among the substances dangerous if swallowed