Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19.01.1999-02.02.1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid
Details on test material:
name: SEPIFEEL ONE
batch: 98174300
aspect: white solid
Specific details on test material used for the study:
name: SEPIFEEL ONE
batch: 98174300
aspect: white solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species: Sprague-Dawley albinos
Origin: IFFA CREDO (69592 L’ARBRESLE Cedex, France)
Age: between 5 and 7 weeks old
5 males and 5 females
Acclimatization period: at least 5 days before the beginning of the study
Weight: at -1 day, individual weight was taken and they were all around the average of all animals +/- 20%
Identification: individual with picric acid
Housing: 5 by cage in polypropylen cages of 31*46*19 cm
Cages were placed in a restricted area, with a higher pressure.
Temperature: 22 +/- 2°C
Relativ humidity: 50 +/- 20%
Lighting : 12/12 hours
Feeding:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
animal were weighed the day before the administration.
5 mL/kg were administrated to the rats.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
no unscheduled death occured.
Clinical signs:
nothing to report.
Body weight:
body weight gain normal
Gross pathology:
nothing to report.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not classifled among the substances dangerous if swallowed.
Executive summary:

ASSESSMENT OF THE ACUTE ORAL TOXICITY IN RAT (LIMIT TEST) - OECD GUIDELINE 401 (24/2/1987)

The aim of the study was to assess qualitatively and quantitatively the toxic effects and the delay of appearance afler single oral administration of 2000 mg/kg body weight, of test substance suspended with distilled water, in 10 rats (5 males and 5 females).

The animals were daily observed for at least 14 days after administration and the signs of toxicily (mortality...) were noted. The test substance was classified as dangerous or not dangerous by ingestion in accordance with the EEC 67/548 Directive and its amendements.

LD0 and LD50 are superior to 2000 mg/kg.

The test substance is not classified among the substances dangerous if swallowed.