Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.