Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The substance chlorocresol is not genotoxic

Link to relevant study records
Reference
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)
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Publication
GLP compliance:
not specified
Type of assay:
other: Salmonella/mammalian microsome test
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S 9 microsome fraction from Aroclor 1254 induced male Wistar rat liver
Test concentrations with justification for top dose:
1.28, 6.4, 32, 160, or 800 ug
Vehicle / solvent:
DMSO
Untreated negative controls:
yes
Remarks:
DMSO
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Sodium azide
Remarks:
strains TA 1535 and TA 100 without S9
Untreated negative controls:
yes
Remarks:
DMSO
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
strains TA 1537 and TA 98 without S9
Untreated negative controls:
yes
Remarks:
DMSO
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-antramine
Remarks:
For all strains with S9
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: no data
Conclusions:
Interpretation of results (migrated information):
negative

4-chloro-3-methylphenol at doses 1.28, 6.4, 32, 160 and 800 ug per plate did not show mutagenic potential in Salmonella tester strain TA 1585, TA 100, TA 1537, and TA 98 with and without S9.
Executive summary:

4-chloro-3-methylphenol at doses 1.28, 6.4, 32, 160 and 800 ug per plate did not show mutagenic potential in Salmonella tester strain TA 1585, TA 100, TA 1537, and TA 98 with and without S9.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Based on studies of target substance CAS NO 59-50-7 reviewed for genetic toxicity from reliable sources having Klimisch rating 2 and 4 considering weight of evidence approach.

 

The summary of the results are presented below

 

Sr. No

End point

Effect

Species

 

Remarks

1

Salmonella/mammalian microsome test

negative with and without S9 metabolic activation

 

TA 1585, TA 100, TA 1537, and TA

Data is from publication for Target chemical

2

Bacterial reverse mutation assay (e.g. Ames test)

 

negative without metabolic activation

 TA 97, TA 100, TA 102, and TA 98

 

Data is from publication for Target chemical

3

 HGPRT assay

negative with without metabolic activation

 Chinese hamster ovary

 

 

Data is from study report for Target chemical

4

bacterial reverse mutation assay (e.g. Ames test)

negative without metabolic activation

TA 1535, TA 1537, TA 100 and TA 98

 

Data is from study report for Target chemical

 

Based on the results summarized in above table for the target chemical CAS NO 59-50-7, it can be concluded that the substance chlorocresol is non-genotoxic.Thus chlorocresol is considered to be non-genetic toxic substance.

Justification for selection of genetic toxicity endpoint

4-chloro-3-methylphenol at doses 1.28, 6.4, 32, 160 and 800 ug per plate did not show mutagenic potential in Salmonella tester strain TA 1585, TA 100, TA 1537, and TA 98 with and without S9.

Justification for classification or non-classification

Chlorocresol can not be classified for genetic toxicity since, it failed to induce a mutagenic response.