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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
read-across based on grouping of substances (category approach)
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:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See 2018_Read-across-Justification_V1 in attached justification

1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See 2018_Read-across-Justification_V1 in attached justification

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See 2018_Read-across-Justification_V1 in attached justification

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dimethyloctadecylamine N-oxide
EC Number:
219-919-5
EC Name:
N,N-dimethyloctadecylamine N-oxide
Cas Number:
2571-88-2
Molecular formula:
C20H43NO
IUPAC Name:
N,N-dimethyloctadecanamine oxide

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: Based on other substance (read-across)

Applicant's summary and conclusion

Conclusions:
As indicated in the read-across justification, data from Amine oxide can be used for read-across to N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) mutagenic potential (Ames test).
For the Amine Oxides group, considering all genotoxicity data, the conclusion is that there is not a concern for genotoxicity.
On the basis of this data, there is no evidence of mutagenicity with or without S9 activation for N,N-Dimethyl-1-octadecanamine-N-oxide.
Executive summary:

As indicated in the read-across justification, data from Amine oxide can be used for read-across to N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) mutagenic potential (Ames test).

For the Amine Oxides group, considering all genotoxicity data, the conclusion is that there is not a concern for genotoxicity.

On the basis of this data, there is no evidence of mutagenicity with or without S9 activation for N,N-Dimethyl-1-octadecanamine-N-oxide.