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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1960
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
The study, Kieckebusch et al. 1960, is referenced in RAC opinion (2012)

Data source

Referenceopen allclose all

Reference Type:
other: RAC oppinion
Title:
Unnamed
Year:
2012
Report date:
2012
Reference Type:
publication
Title:
Die Verträglichkeit der Benzoesäure im chronischen Fütterungsversuch
Author:
Kieckebusch, W., Lang, K.
Year:
1960
Bibliographic source:
Kieckebusch, W., Lang, K., Arzneim. Forsch. 10:1001- 1003 (1960), German

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study, Kieckebusch et al. 1960, is referenced in RAC opinion (2012)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid
EC Number:
200-618-2
EC Name:
Benzoic acid
Cas Number:
65-85-0
Molecular formula:
C7H6O2
IUPAC Name:
benzoic acid
Test material form:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Details on oral exposure:
Not available
Duration of treatment / exposure:
3. generations
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
250 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
No. of animals per sex per dose:
20

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
clinical signs
mortality

Target system / organ toxicity

Key result
Critical effects observed:
no

Any other information on results incl. tables

In summary, it may be concluded that a dose of 500 mg/kg bw/d, as identified as

safe in rodents for subchronic exposure, neither affected survival nor produced clinical

signs of benzoic acid poisoning when exposure time was extended. However, it was indicated in the RAC-background document that the

available chronic toxicity data is not suitable to establish a NOAEL for target organ (liver, kidneys, brain) toxicity.

Applicant's summary and conclusion

Conclusions:
The NOAEL of benzoic acid in the study was 500 mg/kg/day
Executive summary:

Repeated dose exposure to benzoic acid was investigated in male and female rats. The rats were exposed during 16 weeks to 0, 250 or 500 mg/kg/day benzoic acid through feeding. Gross and histopathology was performed after subchronic exposure and body weight was reported for an initial 12/8 wks (M/F) only. The top dose of 10,000 ppm, corresponding to approx. 500 mg/kg bw/d, neither reduced lifetime survival nor produced overt clinical symptoms of benzoic acid poisoning.