Registration Dossier
Registration Dossier
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EC number: 203-118-2 | CAS number: 103-50-4
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Maximum reliability for read across-studies Critical study in OECD risk assessment, 2004.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- No information
- Author:
- Onodera H et.al.
- Year:
- 1 978
- Bibliographic source:
- Eisei Shikenjo Hokoku 96: 47-55
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report for 13th SIAM (Bern, 7th – 9th November 2001) on Benzoates: Benzoic acid, Sodium benzoate, Potassium benzoate, Benzyl alcohol, CAS Nos. 65-85-0, 532-32-1, 582-25-2, and 100-51-6
- Author:
- OECD
- Year:
- 2 004
- Bibliographic source:
- http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?key=9d081a2b-4582-464a-99d7-27749e8b324a&idx=0
Materials and methods
- Principles of method if other than guideline:
- Study with pregnant Wistar rats, dosed with 700, 1400, 2800, 5600 mg/kg sodium benzoate in the diet during the entire gestation; examinations included body weight, food consumption, number of life and dead fetuses, visceral and skeletal investigations of fetuses.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium benzoate
- EC Number:
- 208-534-8
- EC Name:
- Sodium benzoate
- Cas Number:
- 532-32-1
- Molecular formula:
- C7H6O2.Na
- IUPAC Name:
- sodium benzoate
- Details on test material:
- sodium benzoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- during entire gestation period
- Frequency of treatment:
- continuously in diet
- Control animals:
- yes
- Details on study design:
- Study with pregnant Wistar rats, dosed with 700, 1400, 2800, 5600 mg/kg sodium benzoate in the diet during the entire gestation; examinations included body weight, food consumption, number of life and dead fetuses, visceral and skeletal investigations of fetuses.
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 400 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 400 mg/kg bw/day (nominal)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No statistical difference in organ and bone abnormalities of fetuses between experimental groups and controls; growth of treated offsprings was similar to controls in rats dosed with 1400 mg/kg/day; reduced food intake and decreased body weight of the pregnant rats especially in the 5600 mg/kg group; 100% perinatal death rate; organ abnormalities of fetuses involved eye, brain and kidneys, in addition abnormalities of the skeletal system were found in rats dosed with >2800 mg/kg/day. The authors concluded that the effects on the dams and fetuses at the 2800 and 5600 levels were due to reduced maternal feed intake in these groups, leading to malnutrition.
Applicant's summary and conclusion
- Executive summary:
Cited from OECD 2004: "A study using pregnant Wistar rats, dosed with 700, 1400, 2800, 5600 mg/kg sodium benzoate in the diet during the entire gestation showed no statistical difference in organ and bone abnormalities of fetuses between experimental groups and controls; growth of treated offsprings was similar to controls in rats dosed with 1400 mg/kg/day; reduced food intake and decreased body weight of the pregnant rats especially in the 5600 mg/kg group; 100% perinatal death rate; organ abnormalities of fetuses involved eye, brain and kidneys, in addition abnormalities of the skeletal system were found in rats dosed with >2800 mg/kg/day. The authors concluded that the effects on the dams and fetuses at the 2800 and 5600 levels were due to reduced maternal feed intake in these groups, leading to malnutrition, NOAEL Maternal toxicity: 1400 mg/kg bw, NOAEL Teratogenicity: 1400 mg/kg bw."
(Onodera et al. 1978, OECD 2004)
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