Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-08-22 to 1996-09-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no autopsy at the end of the study but no death, normal clinical examination and weight evolution

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
yes
Remarks:
absence of autopsy at the end of the study
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- form: solid (wax)
- batch number: 908MP
- storage: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
- 5 male rats and 5 non gestating rats about 200 to 250g at the time of the trial
- source of the animals: Janvier Le Genest St Isle 53940 FRANCE
- acclimation: at least 5 days in the animal shelter of the laboratory
- house: individual polystyrene cages, room temperature between 18 and 22°C, relative humidity between 50 and 80°C, filtered and recycled air at 3000 cubic meters/hour, 12/12 hours light/dark cycle.
- food (aliment extralabo M20 Ets Pietrement) and tap water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
paraffin oil
Details on oral exposure:
the single dose was administered with a syringue and the gastro-oesophageal probe.
Doses:
2 g/kg
No. of animals per sex per dose:
5 male rats
5 femal rats
Control animals:
no
Details on study design:
- 18 hours before D0: the animals were maintained on a hydric diet
- D0: the animals were weighed. Administration of the product at 2 g/kg bw. Observation of the animals at T+ 1/4h, T+1h, up to T+6h.
- D1 to D14: daily observation of the animals. Behavioural abnormalities (apathy, excitation, palpebral ptosis), nervous attacks (comas, trembling, convulsions), digestive effects (refusal of food or drink, modification of the volume or appearance of faeces or urina) toxic and corrosif vascular effects (buccal, anal, nasal bleeding), eventual deaths
- D7: weighting of the survivals
- D14: weighting of the survivals

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
absence of clinical side effects
Body weight:
normal weight evolution

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The test substance has an innocuousness by oral route at a dose of 2 g/kg bw according to the protocol defined in the guideline.
Executive summary:

The test substance was administrated in 5 male and 5 female rats at the dose of 2 g/kg bw according to the guideline EEC 884L251 25/04/84.

Mortality, clinical behavioural and weight evolution were recored for 14 days after the single oral administration.

The absence of mortality or other clinical side effects (severe apathy, loss of weight) allows to conclude in the total innocuousness of the tested product at the dose administered. This allows to classify the product as non toxic.