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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
A representative bacterial gene mutation has been described, although many studies have been performed
The class of substance has been extensively tested and has proved positive in many types of assay, although there has been inconsistency with certain assays.
A classification of Muta 2 has been assigned by industry based on work mainly relating to 2 -nitro-phenol.

Data source

Reference
Reference Type:
review article or handbook
Title:
Concise International Chemical Assessment Document 20
Author:
World Health Organisation
Year:
2000
Bibliographic source:
International Programme on Chemical Safety, Concise International Chemical Assessment Document 20

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Limited information provided in review document
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-nitrophenol
EC Number:
201-857-5
EC Name:
2-nitrophenol
Cas Number:
88-75-5
Molecular formula:
C6H5NO3
IUPAC Name:
2-Nitrophenol
Specific details on test material used for the study:
Not specified in review

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: Strains not reported
Metabolic activation:
with and without
Metabolic activation system:
S-9
Test concentrations with justification for top dose:
1 - 2500 ug/plate
Vehicle / solvent:
Not specified in review

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with
Genotoxicity:
positive
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:
Concluded positive, even thoughonly one strain reported.
Remarks on result:
other: Only results on TA1538 reported in review as positive

Any other information on results incl. tables

Not specified in review

Applicant's summary and conclusion

Conclusions:
A representative bacterial gene mutation has been described, although many studies have been performed
The class of substance has been extensively tested and has proved positive in many types of assay, although there has been inconsistency with certain assays.
A classification of Muta 2 has been assigned by industry based on work mainly relating to 2 -nitro-phenol.
Executive summary:

Although review concluded positive, the data presented is equivocal.

However, phenolic amides are typically considered to be potentially genotoxic, expecially in mammalian cell-lines