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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
-
EC Number:
423-300-7
EC Name:
-
Cas Number:
128554-52-9
Molecular formula:
Not available
IUPAC Name:
Reaction products of 12-hydroxyoctadecanoic acid and octadecanoic acid and 1,3-phenylenedimethanamine
Test material form:
solid

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S9-homogenate
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 3 ... 333 µg/plate
Concentration range in the main test (without metabolic activation): 3 ... 333 µg/plate
Vehicle / solvent:
Solvent: DMSO
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 333 µg/plate

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
not specified
Remarks:
in migrated NONS file from ECHA
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
not specified
Remarks:
in migrated NONS file from ECHA
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
not specified
Remarks:
in migrated NONS file from ECHA
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 333 µg/plate)
Key result
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
not specified
Remarks:
in migrated NONS file from ECHA
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 333 µg/plate)
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
other:
Remarks:
in migrated NONS file from ECHA
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 333 µg/plate)
Additional information on results:
Observations: None
Remarks on result:
other: No information avaiable

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation