C16-18 (evennumbered), C18 unsaturated alkylamine ethoxylated

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

October 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No info on composition. Basic data given, according to guidelines/standards; incomplete reporting

Justification for type of information:

Data has been read across from a structurally similar substance in a category approach. See further discussion in the read across justification attached.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Remarks:

pre-GLP

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol

EC Number:

620-540-6

Cas Number:

1218787-32-6

Molecular formula:

No molecular formula

IUPAC Name:

2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol

Test material form:

liquid

Details on test material:

- Chemical name: 2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol
- EC number: 620-540-6

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.

Method

Target gene:

Point mutations which involve substitution, addition or deletion of one or a few DNA base pairs

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

no info

Test concentrations with justification for top dose:

0, 0.2, 2, 20, 100 and 500 ug/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not indicated but should be solubility

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

other: 2-acetylaminofluorene (TA98, TA1538), 2-anthramine (TA100, TA1535), 8-aminoquinoline (TA1537)

Remarks:

with metabolic activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

other: 2-nitrofluorone (TA98 and TA1538), methylnitrosoguanidine (TA100, TA1535), quinacrine mustard (TA1537)

Remarks:

without metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: no info

DURATION
- Preincubation period: no info
- Exposure duration: no info (date run was 4 Oct 1978; date read was 6 Oct 1978)

NUMBER OF REPLICATIONS:
3 plates per concentration and strain

DETERMINATION OF CYTOTOXICITY
- Method: observation of the bacterial background lawn for zones of inhibition

Evaluation criteria:

Two times or more the number of spontaneous revertant colonies was considered a positive response.

Statistics:

Not needed.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Slight toxicity was seen at 500 and 100 ug dose levels in both activated and non-activated systems and at 20 ug in the non-
activated systen using test strains TA98, TA100, TA1535 and TA1537. No toxicity was seen at all levels using test strain TA1538.

CONTROL COUMPOUNDS:
The responses of teh control compounds were within the limits set for the test, indicating reliability.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test compound is not genotoxic in vitro in the Salmonella assay using test strains TA98, TA100, TA1535, TA1537, and TA1538. Test strains E. coli WP2 or TA102 were not used.

Executive summary:

Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 were treated with the test compound using the Ames test at 5 dose levels, in triplicate, both with and without metabolic activation. The dose range was determined in a prelimary toxicity assay and was 0.2 to 500 µg/plate. Levels of 20, 100 and 500 µg induced slight toxicity and were also used in the main test. The test was not repeated. The solvent DMSO control plates gave counts of revertant colonies within the normal range. All positive control chemicals produced marked increases in the number of revertant colonies, both with and without metabolic activation. The test compound caused no significant increase in the number of revertant colonies for any of the bacterial strains with or without metabolic activation. The test compound was found to be non-mutagenic under the conditions of this test.