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Registration Dossier
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EC number: 295-786-7 | CAS number: 92128-87-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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
- 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
- Specific details on test material used for the study:
- The soya bean lecithin was used for comparison in this study.
- 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
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 90 days
- Dose / conc.:
- 4 860 mg/kg bw/day (nominal)
- Remarks:
- in males
- 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
- 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.
- 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.
- Dose descriptor:
- NOAEL
- Effect level:
- > 5 460 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- haematology
- Dose descriptor:
- NOAEL
- Effect level:
- > 4 860 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- haematology
- Critical effects observed:
- no
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 4 860 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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