Reaction mass of pentadecylamine and tridecylamine and 2-Methyldodecylamine and 2-Methyltetradecylamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated 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:

other: Comparable to guideline study, part of NTP/USA

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

preincubation assay, two sources of liver microsomes (from rat and hamster)

Principles of method if other than guideline:

acc. to Haworth et al. (1983): Environ. Mutagen. 5, Suppl. 1, 3-142

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecylamine

EC Number:

205-596-8

EC Name:

Hexadecylamine

Cas Number:

143-27-1

Molecular formula:

C16H35N

IUPAC Name:

hexadecan-1-amine

Details on test material:

- Name of test material (as cited in study report): Hexadecylamine (No. 156 in publication)
- Substance type: organic
- Physical state: solid, waxy
- Analytical purity: 90 %
- Impurities (identity and concentrations): no data

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 100, TA 98 and TA 97

Metabolic activation:

with and without

Metabolic activation system:

Metabolic activation systems were derived from Arochlor-induced livers of male SD rats and male Syrian hamsters.

Test concentrations with justification for top dose:

0.3, 1.0, 3.0, 10.0, 33.0, and 100 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Remarks:

corresponds to vehicle control

Negative solvent / vehicle controls:

yes

Remarks:

+ DMSO

Positive controls:

yes

Positive control substance:

other: -S9: Sodium azide (TA1535, TA100); 9-aminoacridine (TA97); 4-nitro-o-phenylenediamine (TA98) // +S9: 2-aminoanthracene (all strains).

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation, agar plate

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days at 37 °C


NUMBER OF REPLICATIONS: 3


DETERMINATION OF CYTOTOXICITY
- relative total growth (background lawn)

Evaluation criteria:

Mutagenic (+) or weakly mutagenic (+w) if a reproducible, dose-related increase in revertants over the corresponding solvent controls in replicate trials was seen.
Questionable (?) if a reproducible increase in revertants did not meet the criteria of either "+" or "+w", or if single doses produced an increase in repeat trials.

Results and discussion

Test results

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 33 µg/plate -S9 (see Appendix 2, p. 95)

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA1535, TA100, TA 98, TA 97 (preincubation assay)

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative