Lecithins, hydrogenated

Endpoint summary

Description of key information

Acute toxicity via oral route:

An OECD 401 test was performed on hydrogentated lecithins.

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.

Acute toxicity via inhalation route: read across on acetylated lecithins

Several attempts were made to generate a respirable 2-5 mg/L atmosphere of the test substance. Due to the high viscosity of the test substance, a respirable atmosphere could not be generated. To facilitate test substance atmosphere generation, the test substance was diluted 50:50 (v/v) with corn oil. Chamber trials demonstrated a respirable atmosphere around 2.0 mg/L could be generated with test substance:corn oil 50:50 (v/v).

Two groups of 5 male and 5 female Crl:CD(SD) rats were exposed nose-only for a single 4-hour period to either the vehicle corn oil or a 50:50 (v/v) mixture of test substance:corn oil in air. Animals were weighed and observed for clinical signs of toxicity during a 14-day recovery period. Rats were exposed to an aerosol concentration of 2.5 ± 1.2 mg/L corn oil (mean ± standard deviation; vehicle control).  

All rats exposed to 2.5 mg/L corn oil (vehicle control) survived the exposure and the subsequent 14-day recovery period. Animals demonstrated no loss in body weight, 1, 7 or 14 days post exposure and no clinical signs of toxicity were observed. Gross pathological examination revealed no evidence of organ-specific toxicity in any of the rats 14 days following the 4-hour exposure to 2.5 mg/L corn oil. All rats exposed to 2.9 mg/L test substance:corn oil 50:50 (v/v) survived the exposure and the subsequent 14-day recovery period. Animals demonstrated no loss in body weight 1, 7 or 14 days post exposure and no clinical signs of toxicity were observed.

Gross pathological examination revealed no evidence of organ-specific toxicity in any of the rats 14 days following the 2.9 mg/L test substance:corn oil 50:50 (v/v). Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC₅₀) for the test substance in male and female rats was greater than 0.89 mg/L, the maximum practically attainable atmospheric aerosol concentration.

Acute toxicity via dermal route:

No study performed since the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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.

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.

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

Preliminary study:

No sign evidencing any toxicity at the level of the central nervous system or neuro-vegetative system was noted.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

please see read across justification section 13.2

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.89 other: mg/L (air) (the maximum practically attainable exposure concentration)

Based on:

test mat.

Exp. duration:

4 h

Interpretation of results:

study cannot be used for classification

Executive summary:

By analogy with data on lecithins, acetylated (EC 293-316-5) the target substance is considered to have an inhalation LC50 > 0.89 mg/L (air) (the maximum practically attainable exposure concentration).

Based on the rat acute oral LD₅₀ value of >2000 mg/kg and the 4-hour LC₅₀in rats of >0.89 mg/L (the maximum practically attainable atmospheric aerosol concentration), this substance is not classified for acute toxicity via the oral, dermal (according to the proposed waiving in IUCLID: the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure), or inhalation routes under REACH regulations and guidance.  

Please see read across justification section 13.2 for more information.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

890 mg/m³

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available