Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation toxicity study was performed by Asim Kumar Debnath et al (Mutation Research, 1992) to determine the mutagenic nature of 3-Bromoquinoline (5332-24-1) using Salmonella typhimurium strains. 3-Bromoquinoline was assessed for its possible mutagenic potential. For this purpose AMES test was performed  in Salmonella typhimurium strains TA 98 and TA 100. The test material was exposed at the concentration of 0, 6.7,10,33,67,100,333,667 and 1000 µg/plate in the presence and absence of S9. No mutagenic effects were observed. Only the data on TA100 with metabolic activation are reported here (Table) as the test substances tested on TA98 with and without S9 activation and on TA100without S9 activation were inactive. Therefore 3-Bromoquinoline was considered to be non mutagenic in presence and absence of S9.Hence the substance cannot be classified as gene mutant in vitro.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of 3-Bromoquinoline in Salmonella typhimurium strains TA 98 and TA 100 by Ames test.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Specific details on test material used for the study:
Details on test material
- Name of test material (as cited in study report):
- Molecular formula: C9H6BrN
- Molecular weight:
- Substance type: 208.057g/mol
- Physical state: Organic
Purity;> 99% using HPLC.
Target gene:
Histidine
Species / strain:
other: TA 98 and TA 100
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 microsomal fraction
Test concentrations with justification for top dose:
0,6.7,10,33,67,100,333,667 and 1000 µg/plate
Vehicle:
Vehicle
- Vehicle(s)/solvent(s) used: DMSO ,50µl
Negative controls:
not specified
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: (+ S9) 2-aminoanthracene ; TA98 and TA100 (-S9) 2-nitrofluorene ; TA98 (-S9)sodium azide;TA 100
Details on test system and conditions:
Details on test system and conditions
METHOD OF APPLICATION: in medium; in agar (plate incorporation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hour

NUMBER OF REPLICATIONS: Triplicates

Other: Plates not counted immediately were stored at 4°C. An automated colony counter was used for counting except when there was interference due to precipitation of test article and then manual counting was used.
Rationale for test conditions:
Not specified
Evaluation criteria:
The revertants/ nmole were calculated by converting dose in Kg to nmole and taking the slope of the linear regression line of the dose-response curve. The logarithms of the slopes (revertants/ nmole) were used as activity parameters
Statistics:
Mean± Standard deviation was observed.
Species / strain:
other: TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: No mutagenic effect were observed.

Sr no

 

Dose

 

Revertants/plate

(mean ±standard

Deviation100 (+ S9)

1

Control

 

 

 

 

DMSO

50µl

153± 3

2

 Test substance name

(µg/plate)

 

 

3 -Bromoquinoline

 

 

 

6.7

152± 17

 

10

160±9

 

33

125±7

 

67

157± 6

 

100

121±15

 

333

133±16

 

667

34±41

 

1000

0±0

 

Conclusions:
3-Bromoquinoline (5332-24-1) was evaluated for its mutagenic potential in Salmonella typhimurium strains TA 98 and TA 100 by Ames test. The test result was considered to be negative with and without S9.
Executive summary:

3-Bromoquinoline was assessed for its possible mutagenic potential. For this purpose AMES test was performed  in Salmonella typhimurium strains TA 98 and TA 100. The test material was exposed at the concentration of 0, 6.7,10,33,67,100,333,667 and 1000 µg/plate in the presence and absence of S9. No mutagenic effects were observed. Only the data on TA100 with metabolic activation are reported here (Table) as the test substances tested on TA98 with and without S9 activation and on TA100without S9 activation were inactive. Therefore 3-Bromoquinoline was considered to be non mutagenic in presence and absence of S9.Hence the substance cannot be classified as gene mutant in vitro.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Genotoxicity In-vitro

Various publications were reviewed to determine the mutagenic nature of 3-Bromoquinoline (5332-24-1). The studies are as mentioned below:

Gene mutation toxicity study was performed by Asim Kumar Debnath et al (Mutation Research, 1992) to determine the mutagenic nature of 3-Bromoquinoline (5332-24-1) using Salmonella typhimurium strains. 3-Bromoquinoline was assessed for its possible mutagenic potential. For this purpose AMES test was performed  in Salmonella typhimurium strains TA 98 and TA 100. The test material was exposed at the concentration of 0, 6.7,10,33,67,100,333,667 and 1000 µg/plate in the presence and absence of S9. No mutagenic effects were observed. Only the data on TA100 with metabolic activation are reported here (Table) as the test substances tested on TA98 with and without S9 activation and on TA100without S9 activation were inactive. Therefore 3-Bromoquinoline was considered to be non mutagenic in presence and absence of S9.Hence the substance cannot be classified as gene mutant in vitro.

In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by Minako Nagao et al. (Mutation Research, 1977) to determine the mutagenic nature 2 Chloroquinoline (612-62-4). The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. In vitro genetic toxicity study was performed to determine the mutagenic nature of 2 chloroquinoline. The study was performed using Salmonella typhimurium strains TA98 and TA100 in the absence and presence of exogenous metabolic activation system. The study was carried out by using Preincubation at 37oC for 20 min. The test chemical was dissolved in DMSO and exposed at a concentration of 0, 4 or 8 µmoles /plate. 2 Chloroquinoline did not induce gene mutation in Salmonella typhimurium strain TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it does not exhibit gene mutation ability in vitro.

In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by Asim Kumar Debnath et al (Mutation Research, 1992) to determine the mutagenic nature of 6-Methylquinoline (91-62-3) using Salmonella typhimurium strains. The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. 6-Methylquinoline was assessed for its possible mutagenic potential. For this purpose AMES test was performed in Salmonella typhimurium strains TA 98 and TA 100. The test material was exposed at the concentration of 0, 3.3,10,33,100 and 333 µg/plate in the presence and absence of S9. No mutagenic effects were observed. Only the data on TA100 with metabolic activation are reported here (Table) as the test substances tested on TA98 with and without S9 activation and on TA100without S9 activation were inactive. Therefore 6-Methylquinoline was considered to be non mutagenic in presence and absence of S9.Hence the substance cannot be classified as gene mutant in vitro.

Based on the data available for the target chemical and applying weight of evidence 3-Bromoquinoline (5332-24-1)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Thus based on the above annotation and CLP criteria for the target chemical . 3-Bromoquinoline (5332-24-1)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.