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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Not mentioned
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across study hence maximum reliability rating of 2 assigned according to ECHA guidance, although study was well documented, meets generally accepted scientific principles, acceptable for assessment; compliant with GLP.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Suspensions of bacterial cells are exposed to the test substance by the plate incorporation method in the presence and in the absence of an exogenous metabolic activation system. In this method, the suspensions are mixed with an overlay agar and plated immediately onto the minimal medium and incubated for two days at 37˚C, The results are interpreted by counting the revertant colonies and comparing to the number of spontaneous revertant colonies on solvent-control plates.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
68603-42-9
Cas Number:
68603-42-9
IUPAC Name:
68603-42-9
Constituent 2
Reference substance name:
Cocamide DEA
IUPAC Name:
Cocamide DEA
Constituent 3
Reference substance name:
Coconut oil acid diethanolamine condensate
IUPAC Name:
Coconut oil acid diethanolamine condensate
Details on test material:
- Name of test material (as cited in study report): Coconut oil acid diethanolamine condensate obtained from radian corporation (Austin, TX).

Method

Target gene:
Not applicable
Species / strain
Species / strain / cell type:
other: S. typhimurium TA97, TA98, TA100 and TA1535
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver).
Test concentrations with justification for top dose:
-Without metabolic activation: 0.0, 0.1, 0.3, 1.0, 3.3 and 6.7 µg/plate
- With metabolic activation: 0.0, 3.3, 10, 33, 100 and 200 µg/plate
Vehicle / solvent:
Ethanol
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
(solvent control)
Negative solvent / vehicle controls:
yes
Remarks:
(ethanol)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
in the absence of metabolic activation

Migrated to IUCLID6: (for strains TA100 and TA1535)
Untreated negative controls:
yes
Remarks:
(solvent control)
Negative solvent / vehicle controls:
yes
Remarks:
(ethanol)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
in the absence of metabolic activation

Migrated to IUCLID6: (for strain TA97)
Untreated negative controls:
yes
Remarks:
(solvent control)
Negative solvent / vehicle controls:
yes
Remarks:
(ethanol)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 4-nitro-o- phenylenediamine (for strain TA98)
Remarks:
in the absence of metabolic activation
Untreated negative controls:
yes
Remarks:
(solvent control)
Negative solvent / vehicle controls:
yes
Remarks:
(ethanol)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (all strains)
Remarks:
in the presence of metabolic activation
Details on test system and experimental conditions:
- Test medium: Top agar supplemented with L-histidine and d-biotin
- Method of application: In agar (plate incorporation)
- Duration of incubation: 2 d at 37 °C
- Number of replicates: Three
Evaluation criteria:
- Positive response: Reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination.
- Equivocal response: An increase in revertants that are not dose related, is not reproducible, or is not of sufficient magnitude to support a determination of m utagenicity.
- Negative response: When no increase in revertant colonies is observed following chemical treatment.
- There is no minimum percentage or fold increase required for a chemical to be judged positive or weakly positive.
Statistics:
Not reported.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: S. typhimurium TA97, TA98, TA100 and TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(at 6.7 µg/plate without metabolic activation in the strain TA 1535; at ≥100 and 200 µg/plate with metabolic activation in the strains TA 97 and TA 100 respectively)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
None
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

For details on results, please refer to the table under the 'Attached background material'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative with metabolic activation

Under the test conditions, the read across test substance was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, or TA1535, with or without S9 metabolic activation.
Executive summary:

A study was conducted by NTP to determine the mutagenic potential of the read across test substance, 'amides, C8 -18 (even-numbered) and C18 -unsatd., N, N-bis(hydroxyethyl)' (in the form of coconut oil acid diethanolamine condensate) in Salmonella typhimurium.

Salmonella typhimurium strains TA97, TA98, TA100 and TA1535 were treated with the test substance using the Ames plate incorporation method at up to eight dose levels for each bacterial strain, in triplicate, both with and without the addition of S9 mix (i.e., Aroclor induced rat and hamster liver homogenate metabolising system). The dose range was 0.1 to 6.7 µg/plate in the absence of S9 mix and from 3.3 to 200 µg/plate in the presence of S9 mix.

 

Cytotoxicity was observed at 6.7 µg/plate without metabolic activation in the strain TA 1535 and at ≥100 and 200 µg/plate with metabolic activation in the strains TA 97 and 100 respectively. No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test substance, either with or without metabolic activation.The vehicle (ethanol) control or the negative control plates produced counts of revertant colonies within the normal range. All the positive control chemicals used in the test produced marked increases in the frequency of revertant colonies, both with and without the S9 -mix.

 

Under the test conditions, the read across test substance was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, or TA1535, with or without S9 metabolic activation.