Isopropylamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study, part of NTP/USA, but incomplete test strain set according to OECD guideline 471

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1987

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 different sources of a microsomal metabolic system; 4 instead of 5 tester strains.

Principles of method if other than guideline:

Ames-Test modified 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:

Isopropylamine

EC Number:

200-860-9

EC Name:

Isopropylamine

Cas Number:

75-31-0

Molecular formula:

C3H9N

IUPAC Name:

propan-2-amine

Test material form:

liquid

Details on test material:

Isopropylamine [CAS No. 75-31-0], purity 99% (Aldrich Chemicals)
(No. 159 in publication)

Method

Species / strain

Species / strain / cell type:

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

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:

0.010, 0.033, 0.100, 0.333, 1.0, 3.333 mg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Test substance well soluble in water

Controls

Untreated negative controls:

no

Remarks:

corresponds to vehicle control

Negative solvent / vehicle controls:

yes

Remarks:

distilled water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: -S9: Sodium azide (TA1535, TA100); 9-aminoacridine (TA1537); 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

Key result

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 3.333 mg/plate (see Report, Appendix 2, p. 79/80)

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

--

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study there was no mutagenicity in bacteria with and without metabolic activation

Executive summary:

The mutagenic activity of the test substance (purity > 99%) was examined in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 in concentrations of 0, 10, 33, 100, 333, 1000, 3333 and 10000 µg/plate, without or with metabolic activation by Aroclor 1254-induced rat and hamster S9 liver extracts.

No cytotoxicty was observed up to the highest concentration.The test item did not produce a mutagenic response in any of the strains tested with or without metabolic activation.