3-chloroaniline

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)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Salmonella mutagenicity tests. III. Results from the testing of 225 chemicals

Author:

ZEIGER,E, ANDERSON,B, HAWORTH,S, LAWLOR,T, MORTELMANS,K AND SPECK,W

Year:

1987

Bibliographic source:

Environ. Mutagen. Vol. 9 (Suppl 9) (1987) 1-109

Reference 2

Reference Type:

other: Authoritative data base

Title:

NTP Study ID:309708

Author:

NTP

Year:

2012

Bibliographic source:

NTP (National Toxicological Program)by Agency for Toxic Substances and Disease Registry; Division of Toxicology/Toxicology Information Branch, 1600 Clifton Road NE, E-29, Atlanta, Georgia 30333

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium (or E. coli) plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen*. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine or tryptophan appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine- or tryptophan- manufacturing gene. The number of colonies is usually counted after 2 days.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-chloroaniline

EC Number:

203-581-0

EC Name:

3-chloroaniline

Cas Number:

108-42-9

Molecular formula:

C6H6ClN

IUPAC Name:

3-chloroaniline

Details on test material:

- Name of test material (as cited in study report): 3-chloroaniline
- Substance type: Organic
- Physical state: solid

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

not specified

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 1537

Additional strain / cell type characteristics:

not specified

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 97

Additional strain / cell type characteristics:

not specified

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

10% & 30% RLI = induced male Sprague Dawley rat liver S9 and 10% & 30% HLI = induced male Syrian hamster liver S9

Test concentrations with justification for top dose:

33 - 2000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Dimethyl Sulfoxide (DMSO)

Controls

Controls 1

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

For strains tested with S9

Controls 2

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

For strains TA100 and TA1535 tested in the absence of S9

Controls 3

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

For strains TA97 and TA1537 tested in the absence of S9

Controls 4

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine

Remarks:

For strain TA98 tested in the absence of S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 3

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 4

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 5

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Strain: TA100

Dose	No Activation  (Negative)		No Activation  (Negative)		30% RLI  (Negative)		30% HLI  (Negative)		10% RLI  (Negative)		10% HLI  (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM
0	118	11.9	98	4.4	120	5.5	121	2.4	112	2.2	94	4.2
33	126	8.8	94	2.3	139	5.2	110	3.5	104	7.2	101	3.8
100	123	8.4	95	3.8	139	10	120	9.5	101	2.3	103	9.4
333	125	9.4	98	6.7	127	3.2	130	4.8	107	2.3	97	7.1
1000	111	4.8	61	7.9	116	7.2	122	9	103	3.8	89	3.3
1500			48	21.2							12	10
2000	64	3.5			74	9.7	100	9
Positive Control	476	8	310	6	560	58	728	9	570	13.7	409	10.7

Strain: TA1535

Dose	No Activation  (Negative)		No Activation  (Negative)		30% RLI  (Negative)		30% HLI  (Negative)		10% RLI  (Negative)		10% HLI  (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM
0	26	4.2	20	3	13	.9	13	1.9	10	1	10	0
33	18	1.9	15	3.2	9	2	11	1.7	10	1.8	12	1.5
100	29	2.5	16	.9	13	1.8	9	1.5	10	1.8	8	2
333	27	3.2	14	2	8	.9	9	.7	8	.7	13	2.3
1000	23	4.7	12	1	7	1.7	13	.9	8	1.8	10	1.2
1500			15	5							4	1
2000							12	2.5
Positive Control	291	5.8	220	12	143	.3	228	53.1	145	9.8	59	2.8

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In an Ames test , 3-chloroaniline, in dimethyl sulfoxide from doses 33 - 2000 µg/plate was not mutagenic in Salmonella typhimurium strains TA100 , TA 1535, TA1537 , TA 97 and TA 98 with and without addition of S9 liver microsome fractions from Aroclor induced rats.The same has been obtained for hamsters as well.

Executive summary:

In an Ames test , 3-chloroaniline, in dimethyl sulfoxide from doses 33 - 2000 µg/plate was not mutagenic in Salmonella typhimurium strains TA100 , TA 1535, TA1537 , TA 97 and TA 98 with and without addition of S9 liver microsome fractions from Aroclor induced rats.The same has been obtained for hamsters as well.