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Toxicological information

Developmental toxicity / teratogenicity

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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:
1990
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:
2005
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
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals 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 / concentrations
Remarks:
Doses / Concentrations:
0, 125, 250, 500 mg/kg bw/day
Basis:
no data
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:
Maternal toxic effects:yes

Details on maternal toxic effects:
Toxic signs included death, clinical observations and changes in body weight and feed consumption

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:
Embryotoxic / teratogenic effects:no data

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.