Isopropyl benzoate

Genetic toxicity: in vivo

Administrative data

Endpoint:

genetic toxicity in vivo

Remarks:

Type of genotoxicity: other: chromosome damage and dominant lethal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This is a summary of studies reviewed by an authoritative body(Scientific Committee on Food), which accepted the data as scientifically valid.

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guidelines 475 and 478

Principles of method if other than guideline:

summary of OECD 475 and 478 tests

GLP compliance:

not specified

Type of assay:

other:

Test material

Test material information

Constituent 1

Reference substance name:

Sodium benzoate

EC Number:

208-534-8

EC Name:

Sodium benzoate

Cas Number:

532-32-1

IUPAC Name:

sodium benzoate

Constituent 2

Reference substance name:

benzoic acid, sodium salt

IUPAC Name:

benzoic acid, sodium salt

Details on test material:

sodium benzoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Administration / exposure

Route of administration:

oral: gavage

Duration of treatment / exposure:

single or repeated dosing (5 days)

Frequency of treatment:

once daily

Doses / concentrations

Remarks:

Doses / Concentrations:
50, 500 and 5000 mg/kg bw/day
Basis:
nominal conc.

Examinations

Tissues and cell types examined:

bone marrow for the chromosome aberrations assay, and uterine implantation sites in pregnant female rats for the dominant lethal assay.

Results and discussion

Test results

Sex:

not specified

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

This is a summary from the Opinion of the SCF on benzoic acid and its salts: a chromosomal aberration assay was carried out in bone marrow cells of Sprague-Dawley rats exposed by gavage to single or repeated doses for 5 consecutive days of 50, 500 and 5000 mg/kg bw/day sodium benzoate, with negative results. Also, a dominant lethal test using 50, 500 or 5000 mg/kg bw/day as a single or multiple (5 days) doses to male Sprague-Dawley rats was negative.

While some of the in vitro tests have been positive or equivocal (for benzoic acid and its salts), all the results fromin vivostudies have been negative. It is therefore concluded that an in vivo study for clastogenic activity on benzoic acid (previously requested, SCF, 1994) should no longer be required.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
The SCF reveiwed available in vivo data on the genotoxicity of sodium benzoate (and other related substances) and concluded that the substance is not mutagenic in vivo. This study is informative for evaluation of the toxicity of members of the Alkyl Benzoates category, and is adequate for filling the data requirement for the registration of this substance. It is valid for hazard classification and risk assessment.