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Administrative data

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

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
February the 24th, 1987
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Reference substance name:
Lecithins, hydrogenated
EC Number:
EC Name:
Lecithins, hydrogenated
Cas Number:
Molecular formula:
not applicable - UVCB substance
Lecithins, hydrogenated
Specific details on test material used for the study:
Container : transparent glass flasks
label : 89.627
Colour : white
pH : 6,88
stored at room temperature for three years at most.

The product was administered undiluted.

Test animals

Details on test animals or test system and environmental conditions:
- Origin : rats originated from IFFA CREDO (69210 L'ARBRESLE, FRANCE).
- Age at the beginning of the study : 2 months old
- Weight at the beginning of the study : Male 194.4 +/- 11.5 g / Female : 170,8 ± 5,1 g
- Individually identified by picric acid mark.
- Acclimatation period of 7 days

Housing :
The animaIs were housed 5 by 5 of same sex in makrolon boxes (46,5 x 31 x 19 cm) whose floor was covered with soft wood sawdust (UAR 96360 VILLEMOISON) .
The stainless steel wire cover was fitted with a feeding-device and a 500 ml feeding-bottle .
Boxes were kept in an air conditioned room with 12 hours artificial and natural lighting (air change : 14 cycles per hour , temperature : 22°C ± 4°c, relative humidity of 56 ± 12)

Water and Food :
AnimaIs received tap water and food (UAR A04c) ad libitum.

The animaIs were placed on a hydric diet on the day before the trial, i.e. 16 hours before treatment.

Administration / exposure

Route of administration:
oral: gavage
not specified
Details on oral exposure:
The product to be monitored was administered in a single dose, by gastric force-feeding, using a syringe graduated in 100th of a millilitre, fitted with a oesophageal probe (L = 7,5cm).
1 dose (limit trial only), 2g/kg (1,63ml/kg of the preparation was therefore administered)
No. of animals per sex per dose:
5 male rats and 5 female rats
Control animals:
not specified
Details on study design:
Clinical examination :
- During the 3 hours following product administration, the animals were quasi continuously observed in order to note the clinical signs of toxicity.
- During the following 14 days, a daily observation was made.
- The symptoms were recorded for each sex on an observation form.
- A mortality check was made at least twice a day.

Weight growth :
- All the animals were individually weighed on D-3, DO just before the product application and on D4, D7 and D14.

Necropsic examinations :
- On D14, the animais were sacrificed by cutting the femoral artery after the animais have been anaesthetized.
- A systematic examination of the main vital organs was performed.
- Observations were recorded on a necropsic form by sex.
Not specified

Results and discussion

Preliminary study:
No sign evidencing any toxicity at the level of the central nervous system or neuro-vegetative system was noted.
Effect levels
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No deaths were recorded.
Body weight:
The weight increase of the male and female animaIs was normal, and comparable to that of animaIs from this strain.
Other findings:
No sign evidencing any toxicity at the level of the central nervous system or neuro-vegetative system was noted.
The autopsies lesion performed at the end of the trial failed to reveal any level of the organs examined

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Under the experimental conditions employed, the test substance, administered orally at a dose rate 2g/kg, failed to lead to any mortality.

The autopsy of the animals at the end of the trial failed to evidence any macroscopic lesions that could be related to a tox effect of the product.

The minimal lethal dose of the product is therefore : greater than 2g / kg in the Sprague Dawley rat, when administered in a single, oral dose.