Lecithins, hydrogenated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25/05/1989-08/06/1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February the 24th, 1987

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lecithins, hydrogenated

EC Number:

295-786-7

EC Name:

Lecithins, hydrogenated

Cas Number:

92128-87-5

Molecular formula:

not applicable - UVCB substance

IUPAC Name:

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

Species:

rat

Strain:

Sprague-Dawley

Remarks:

OFA

Sex:

male/female

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

Vehicle:

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).

Doses:

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.

Statistics:

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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

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.