Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: original data not available

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1972

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
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:
purity not given

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
day 6-15 of gestation
Frequency of treatment:
once daily
Doses / concentrations
Remarks:
Doses / Concentrations:
1.75; 8; 38 or 175 mg/kg/d
Basis:

Control animals:
yes, concurrent no treatment

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
>= 175 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
>= 175 mg/kg bw/day
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 effect on nidation or on maternal or fetal survival; the number of abnormalities of soft and skeletal tissues did not differ from number in controls; maternal toxicity was not reported at any dose applied.

Applicant's summary and conclusion