Lecithins, hydrogenated

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Re-evaluation of Lecithins (E 322) as a food additive

Author:

EFSA

Year:

2017

Bibliographic source:

EFSA Journal 2017;15(4):4742

Reference 2

Reference Type:

publication

Title:

Short-term toxicity study of emulsifier YN in rats.

Author:

Gaunt et Al.

Year:

1967

Bibliographic source:

Food and Cosmetics Toxicology, 5, 623–629.

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The guideline is not specified, but this is a litterature review by a reliable source, which is therefore considered as relevant. Indeed, this test is mentioned in the EFSA (European Food Safety Autority) re-evaluation of Lecithins (E322) as a food additive report.
Groups of 15 male and 15 female rats(Weanling SPF rats of the Carworth Farm E strain) were fed diets containing 0.0% (control) or 6.0% soya bean lecithins, equivalent to 4,860 mg/kg bw per day for males and 5,460 mg/kg bw per day for females, respectively in a 90-day study. Body weight and food consumption were recorded weekly. Haematological investigations were made during week 6 with blood collected from the tail veins of 10 animals of each sex from the control, 6% test item and 6% lecithin groups, and terminally on all animals using blood collected from the dorsal aorta.

GLP compliance:

not specified

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:

The soya bean lecithin was used for comparison in this study.

Test animals

Species:

rat

Strain:

other: Weanling SPF rats of the Carworth Farm E strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

15 males and 15 females

Administration / exposure

Route of administration:

oral: feed

Duration of treatment / exposure:

90 days

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

4 860 mg/kg bw/day (nominal)

Remarks:

in males

Doses / concentrations 2

Dose / conc.:

5 460 mg/kg bw/day (nominal)

Remarks:

in females

No. of animals per sex per dose:

15

Control animals:

yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:

Haematological investigations were made during week 6 with blood collected from the tail veins of 10 animals of each sex from the control, and lecithin groups, and terminally on all animals using blood collected from the dorsal aorta.

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Description (incidence and severity):

No significant differences of relative organ weight were noted.

Haematological findings:

effects observed, non-treatment-related

Description (incidence and severity):

There was slight anaemia in females receiving 5460 mg/kg bw lecithin for 6 weeks but this effect was absent terminally. The osmotic fragility of the erythrocytes of rats on the lecithin diet was comparable with that of the controls.
There was no deviation from normality in respect of the terminal serum chemistry tests conducted at 6 or 13 weeks

Urinalysis findings:

no effects observed

Description (incidence and severity):

There was no deviation from normality in respect of the renal function tests conducted at 6 or 13 weeks.

Histopathological findings: non-neoplastic:

no effects observed

Description (incidence and severity):

At necroscopy, no gross changes were seen.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

> 5 460 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

female

Basis for effect level:

haematology

2

Dose descriptor:

NOAEL

Effect level:

> 4 860 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male

Basis for effect level:

haematology

Target system / organ toxicity

Critical effects observed:

no

Applicant's summary and conclusion

Executive summary:

The NOAEL of the test substance was 4860mg/kg bw in male rats and 5460mg/kg bw in female rats. The substance is therefore of a low toxicity.