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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
Teratological test results in three species of animals (mice, rat and rabbits)
Author:
FDA (food and drug administration)
Year:
1974
Bibliographic source:
FDA

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:furthermore, the mentioned study is from FDA.
In a mice study, groups of 21–23 pregnant albino CD-1 mice were dosed via gavage with 0, 16, 74.3, 345 or 1,600 mg/kg bw per day lecithin in corn oil (dose volume 10 mL/kg bw) from gestational day (GD) 6 to 15 (FDA, 1974). Body weights were recorded on GD 0, 6, 11 and 15, and at necropsy
on GD 17.
GLP compliance:
not specified

Test material

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

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
groups of 21–23 pregnant albino CD-1

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
Mice were treated from gestationalday (GD) 6 to 15.
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Dose / conc.:
16 mg/kg bw/day
Dose / conc.:
74.3 mg/kg bw/day
Dose / conc.:
345 mg/kg bw/day
Dose / conc.:
1 600 mg/kg bw/day
Control animals:
yes, concurrent vehicle

Examinations

Parental animals: Observations and examinations:
Body weights
were recorded at regular intervals during gestation and all animals were observed daily for appearance
and behaviour.
Litter observations:
All dams were subjected to caesarean section, and the numbers of implantation sites,
resorption sites, live and dead fetuses, and body weight of live fetuses were recorded. All fetuses were
examined grossly for external abnormalities, one-third underwent detailed visceral examinations and
two-thirds were stained and examined for skeletal defects.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
>= 1 600 mg/kg bw/day
Based on:
not specified
Sex:
female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
organ weights and organ / body weight ratios

Target system / organ toxicity (P0)

Critical effects observed:
no

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings:
no effects observed

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
ca. 1 600 mg/kg bw/day
Sex:
male/female
Basis for effect level:
viability
clinical signs
body weight and weight gain
organ weights and organ / body weight ratios

Target system / organ toxicity (F1)

Critical effects observed:
no

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Executive summary:

In a mice developmental study, no adverse effects were noted at doses of up to 1,600 mg/kg bw per day.