2-bromoethylammonium bromide

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for Ethanamine, 2-bromo-, hydrobromide (1:1) (IUPAC name: 2-bromoethanaminium bromide). The study assumed the use of Salmonella typhimurium strain TA100 with S9 metabolic activation system. Ethanamine, 2-bromo-, hydrobromide (1:1) failed to induce mutation in Salmonella typhimurium strain TA100 in the presence of S9 metabolic activation system and hence the chemical is predicted to not classify as a gene mutant in vitro.

Based on the predicted result it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.

Link to relevant study records

Reference

Endpoint:

genetic toxicity in vitro, other

Remarks:

gene mutation study in yeast

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Reverse mutation was studied for the 2-Bromoethaneamine hydrobromide using yeast Schizosaccharomyces pombe

GLP compliance:

not specified

Type of assay:

other: Schizosaccharomyces pombe gene mutation assay

Specific details on test material used for the study:

- Name of test material: 2-Bromoethaneamine hydrobromide
- Molecular formula: C2H6BrNBrH
- Molecular weight: 204.892 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Target gene:

his52, his7, met4, ade6 and ade7

Species / strain / cell type:

yeast, other: Schizosaccharomyces pombe strain Arg 1

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

without

Metabolic activation system:

Exogeneous metabolic activation system- S9 and S100

Test concentrations with justification for top dose:

No data

Vehicle / solvent:

No data

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

No data

Rationale for test conditions:

No data

Evaluation criteria:

The yeast cells were observed for reversion of mutation

Statistics:

No data

Species / strain:

yeast, other: Schizosaccharomyces pombe strain Arg 1

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

Table: Chemicals Tested for Mutagenicity on Stationary Phase Cells of Schizosaccharomyces pombe

Chemical	Strain	Metabolic activation	Genetic end point	Genetic activity
2-Bromoethaneamine hydrobromide	Arg 1	-	Reverse mutation	+

 

Conclusions:

2-Bromoethaneamine hydrobromide induced reversion of mutation in yeast Schizosaccharomyces pombe and hence the chemical is likely to be mutagenic to yeast cells.

Executive summary:

Reverse mutation was studied for the 2-Bromoethaneamine hydrobromide using yeast Schizosaccharomyces pombe strain Arg 1. The study was performed without exogeneous metabolic activation system at either of the his52, his7, met4, ade6 and ade7 locus. All these systems allow the evaluation of back mutation induction at the original mutant site. 2-Bromoethaneamine hydrobromide induced reversion of mutation in yeast Schizosaccharomyces pombe without exogeneous metabolic activation system and hence the chemical is likely to be mutagenic to yeast cells.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Gene mutation in vitro:

Prediction model based estimation for the target chemical and variuos peer reviewed publications for the target and read across chemical were and are summarized below to determine the mutagenic nature of Ethanamine, 2-bromo-, hydrobromide (1:1) (IUPAC name: 2-bromoethanaminium bromide):

Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for Ethanamine, 2-bromo-, hydrobromide (1:1) (IUPAC name: 2-bromoethanaminium bromide). The study assumed the use of Salmonella typhimurium strain TA100 with S9 metabolic activation system and strain TA1535 without S9 metabolic activation system. Ethanamine, 2-bromo-, hydrobromide (1:1) failed to induce mutation in Salmonella typhimurium strain TA100 in the presence of S9 metabolic activation system and strain TA 1535 in the absence of S9 metabolic activation system and hence the chemical is predicted to not classify as a gene mutant in vitro.

Another study for the target chemical was conducted by Lopreino et al (Mutation Research, 1983) on yeast. Reverse mutation was studied for the 2-Bromoethaneamine hydrobromide using yeast Schizosaccharomyces pombe strain Arg 1. The study was performed without exogeneous metabolic activation system at either of thehis52, his7, met4, ade6 and ade7locus. All these systems allow the evaluation of back mutation induction at the original mutant site. 2-Bromoethaneamine hydrobromide induced reversion of mutation in yeast Schizosaccharomyces pombe without exogeneous metabolic activation system and hence the chemical is likely to be mutagenic to yeast cells.

Gene mutation study for structurally and fuctionally similar read across chemical (RA CAS no 1119 -48 -8) was also reviewed. This study was given by Wellis et al ( Journal Of Applied Toxicology, 1988). The study was performed to determine the mutagenic nature of 4-(Methylamino)butanoic acid. Plate incorporation assay was performed at dose levels of 0.01 – 316µmol/plate. Concurrent positive and negative controls were incorporated in the study. All assay procedures were performed under yellow light to avoid photodynamic effects. Revertant colonies were counted manually or with a Biotran II automated colony counter. 4-(Methylamino)butanoic acid failed to induce gene mutation in Salmonella typhimurium strain TA100, TA102, TA104, TA97, TA98, TA2638, UTH8413 and UTH8414 both in the presence and absence of S9 metabolic activation system nad hence the chemical is not likely to classify as a gene mutant in vitro.

In another study for structurally and functionally similar read across (RA CAS no 56 -40 -6), Gene mutation toxicity study was performed by Haworth et al ( Environmental Mutagenesis, 1983) to determine the mutagenic nature of the test compound glycine (IUPAC name: Aminoacetic acid). The study was performed by the preincubation protocol usingSalmonellatyphimurium strains TA1535, TA1537, TA98, and TA100 both in the presence and absence of S9 metabolic activation system. Preincubation was carried at 37°C for 20 mins followed by exposure period of 48 hrs at dose levels of 0, 10, 33, 100, 333 or 1000µg/plate (in lab 1) and 0, 100, 333, 1000, 3333 or 10000µg/plate (in lab 2). A dose related increase in the number of revertants was noted whether it be twofold over background or not. The test compound Glycine failed to induce mutation in the Salmonella typhimurium strains TA1535, TA1537, TA98, and TA100 both in the presence and absence of S9 metabolic activation system and hence the chemical is not likely to classify as a gene mutant in vitro.

As one of the study performed is on yeast, Saccharomyces pombe and positive results have been noted in the absence of metabolic activation system and no results were observed using metabolic activation system which is one of the important criteria to evaluate gene mutation. No other studies reflecting the positive nature of the test chemical were found. Hence, based on the information observed for the test chemical and its various read across, it is summarized that Ethanamine, 2-bromo-, hydrobromide (1:1) (IUPAC name: 2-bromoethanaminium bromide) is not likely to exhibit genetic toxicity. Thus, the chemical is not classified as a genetic toxicant as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

As one of the study performed is on yeast, Saccharomyces pombe and positive results have been noted in the absence of metabolic activation system and no results were observed using metabolic activation system which is one of the important criteria to evaluate gene mutation. No other studies reflecting the positive nature of the test chemical were found. Hence, based on the information observed for the test chemical and its various read across, it is summarized that Ethanamine, 2-bromo-, hydrobromide (1:1) (IUPAC name: 2-bromoethanaminium bromide) is not likely to exhibit genetic toxicity. Thus, the chemical is not classified as a genetic toxicant as per the criteria mentioned in CLP regulation.