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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Maximum reliability for read across-studies Critical study in OECD risk assessment, 2004: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
No information
Author:
Kimmel CA et.al.
Year:
1971
Bibliographic source:
Teratology 4: 15-24
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:
2004
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:
Pregnant Wistar rats were treated on day 9 of gestation with one dose of benzoic acid in carboxymethylcellulose. Animals were sacrificed on day 20 of gestation and the uterus observed in situ for implantation and resorption sites. Live fetuses were removed, examined for gross malformations, weighed, and prepared for histological examination. Skeletal examination was carried out under low magnification.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
benzoic acid, purity not noted

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Duration of treatment / exposure:
once on gestation day 6
Frequency of treatment:
once
Duration of test:
20 days
Details on study design:
Pregnant Wistar rats were treated on day 9 of gestation with one dose of benzoic acid in carboxymethylcellulose. Animals were sacrificed on day 20 of gestation and the uterus observed in situ for implantation and resorption sites. Live fetuses were removed, examined for gross malformations, weighed, and prepared for histological examination. Skeletal examination was carried out under low magnification.

Group I was dosed with 510 mg/kg. Group II was dosed with 510 mg/kg; then 2 h later: 250 or 500 mg/kg acetylsalicylic acid.

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
510 mg/kg bw/day (actual dose received)
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
510 mg/kg bw/day (actual dose received)
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

Treatment with benzoic acid alone resulted in no dead or resorbed implants and 3 % abnormal survivors, rates comparable to the control animals.

Applicant's summary and conclusion

Executive summary:

Cited from OECD 2004: "Pregnant Wistar rats were treated on day 9 of gestation with one dose of 510 mg/kg benzoic acid in carboxymethylcellulose. Animals were sacrificed on Day 20 of gestation and the uterus observed in situ for implantation and resorption sites. Live fetuses were removed, examined for gross malformations, weighed, and prepared for histopathological examination. Treatment with benzoic acid resulted in no dead or resorbed implants and 3 % abnormal survivors, rates comparable to the control animals. NOAEL Maternal toxicity: 510 mg/kg bw; NOAEL Teratogenicity: 510 mg/kg bw."

(Kimmel et al. 1971, OECD 2004)