Registration Dossier
Registration Dossier
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EC number: 204-465-2 | CAS number: 121-33-5
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: Lack of data, but evaluated by EFSA.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- An evaluation of food flavoring ingredients using an in vivo reproductive and developmental toxicity screening test
- Author:
- Vollmuth TA, Bennett MB, Hoberman Am and Christian MS
- Year:
- 1 990
- Bibliographic source:
- Teratology, 41(5), 597-598
- Reference Type:
- grey literature
- Title:
- Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission related to:|Flavouring Group Evaluation 20: Benzyl alcohols, benzaldehydes, a related acetal. . .
- Author:
- The EFSA Journal (2005), 296, 1-117.
- Year:
- 2 005
- Bibliographic source:
- The EFSA Journal (2005), 296, 1-117.
Materials and methods
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Vanillin
- EC Number:
- 204-465-2
- EC Name:
- Vanillin
- Cas Number:
- 121-33-5
- Molecular formula:
- C8H8O3
- IUPAC Name:
- 1-butoxypropan-2-ol
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- 1 week before mating until 4 days post parturition
- Frequency of treatment:
- no data
- Duration of test:
- no data
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 150 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- No. of animals per sex per dose:
- 10 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no data
Examinations
- Maternal examinations:
- clinical signs, body weight and feed consumption were recorded throughout the study. Mating performance, fertility, duration of gestation/
parturition, maternal behavior, litter sizes, dystocia, number of implantation sites, and gross lesions at necropsy were also examined. - Ovaries and uterine content:
- no data
- Fetal examinations:
- viability, sex, external morphology, and body weight at birth and on day 4 postpartum.
- Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Toxic signs included death, clinical observations and changes in body weight and feed consumption observed at the highest tested dose.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- There is no effect on pups.
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day
- Basis for effect level:
- other: Teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Vanillin was considered to have no teratogen effects.
- Executive summary:
10 female rats per group were exposed one week before mating until 4 days post partum to 0, 125, 250, 500 mg/kg bw/day of Vanillin. Maternal toxicity had been reported with only few details: death, clinical signs and change in body weight and feed consumption. The NOAEL maternal was consider to be 250 mg/kg bw. No effect on pups were reported and the NOEL for teratogenicity was the highest dose tested 500 mg/kg bw.
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