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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity Produced by Aqueous Chlorination of Organic Compounds
Author:
W. Howard Rapson, Mark A. Nazar, and Victor V. Butsky
Year:
1980
Bibliographic source:
Bull. Environm. Contam. Toxicol, 24,590-596 (1980)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Similar to OECD 471
Principles of method if other than guideline:
Gene mutation toxicity study was performed to determine the mutagenic nature of the test compound p-Hydroxybenzoic acid using Salmonella typhimurium strain TA100
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-hydroxybenzoic acid
EC Number:
202-804-9
EC Name:
4-hydroxybenzoic acid
Cas Number:
99-96-7
Molecular formula:
C7H6O3
IUPAC Name:
4-Hydroxybenzoic acid
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report):4-Hydroxybenzoic acid
- Substance type:Organic
- Physical state:Solid
Specific details on test material used for the study:
- Name of test material: p-Hydroxybenzoic acid
- IUPAC name: 4-Hydroxybenzoic acid
- Molecular formula: C7H6O3
- Molecular weight (if other than submission substance): 138.1214 g/mol
- Substance type: Organic
- Physical state: No data available
- Purity No data available
- Impurities (identity and concentrations): No data available

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified
Metabolic activation system:
No data
Test concentrations with justification for top dose:
0.1, 1, 10, 100 or 1000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: No data available
- Justification for choice of solvent/vehicle: No data available
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
No data
Rationale for test conditions:
No data
Evaluation criteria:
Increase in the number of dose dependent spontaneous revertants
Statistics:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium TA 100
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data available
Remarks on result:
other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:
p-Hydroxybenzoic acid is not mutagenic in the bacterium Salmonella typhimurium TA 100 and hence is not likely to classify as gene mutant in vitro.
Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of the test compound p-Hydroxybenzoic acid.

 

The study was performed as part of mutagenicity produced by aqueous chlorination of organic compounds at dose level of 0.1, 1, 10, 100 or 1000  µg/plate.

 

p-Hydroxybenzoic acid did not induce reversion of mutant strains without chlorination and henceis not mutagenic in the bacterium Salmonella typhimurium TA 100 and hence is not likely to classify as gene mutant in vitro.