Registration Dossier

Administrative data

Description of key information

Information given in the EU risk assessment report of the substance (2009), p. 67-68:
4.1.2.8 Carcinogenicity
4.1.2.8.1 Studies in animals
In vivo studies
No data available.
4.1.2.8.2 Studies in humans
No data available.
4.1.2.8.3 Summary of carcinogenicity
At present, the carcinogenic potential of 4-tert-butylbenzoic acid has not been examined in
human populations and no animal studies have been conducted. No conclusion can be drawn
on the carcinogenic potential of the substance. However, positive data from in vitro
micronucleus testing may give concern on genotoxic properties of 4-tert-butylbenzoic acid.
If further testing will be required, their results have to be taken into considerations.
The sodium salt of benzoic acid did not produce increases in tumor incidences in
carcinogenicity studies on mice (Toth, 1984) and rats (Sodemoto & Enomoto, 1980; study
with restricted validity because of high mortality rates due to infectious pneumonia).

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: data contained in EU risk assessment report of the substance - credibility is assumed. Reference to origin (Toth B; Sodemoto Y and Enomoto M). Read-across applies.
GLP compliance:
not specified
Species:
other: mouse and rat

"4.1.2.8.3 Summary of carcinogenicity

... The sodium salt of benzoic acid did not produce increases in tumor incidences in carcinogenicity studies on mice (Toth, 1984) and rats (Sodemoto & Enomoto, 1980; study with restricted validity because of high mortality rates due to infectious pneumonia)."

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Sodemoto & Enomoto, 1980; study with restricted validity because of high mortality rates due to infectious pneumonia.

Additional information

No valid data is available to evaluate the carcinogenicity of 4-tert-butylbenzoic acid. The EU report points out the limited reliability of two studies performed using sodium benzoate as test substance (test animals were not in a healthy status). No increase in tumour incidences were found in these studies. In addition to deficiencies concerning the test animals the read-across approach applies.


Justification for selection of carcinogenicity via oral route endpoint:
Only information according to European Union Risk Assessment Report (July 2009, FINAL APPROVED VERSION) on carcinogenicity of a substance similar to PTBBA (sodium salt of benzoic acid).

Justification for classification or non-classification

A classification in respect of carcinogenicity is not possible based on the available data.