Registration Dossier
Registration Dossier
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EC number: 295-786-7 | CAS number: 92128-87-5
Toxicity to reproduction
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:
- 1 974
- 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
- 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
Constituent 1
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.
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