1,4-dichlorobenzene

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:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,4-dichlorobenzene

EC Number:

203-400-5

EC Name:

1,4-dichlorobenzene

Cas Number:

106-46-7

Molecular formula:

C6H4Cl2

IUPAC Name:

1,4-dichlorobenzene

Test material form:

other: solid

Details on test material:

IUCLID4 Test substance: other TS: purity > 99 %; solvent: DMSO

Method

Target gene:

Ames assay: detection of base pair substitutions and frameshift mutations

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538

Additional strain / cell type characteristics:

other: S. typhimuriumTA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Metabolic activation system:

liver S9-mix from male Sprague-Dawley rats pretreated with i.p. injection of Aroclor in olive oil

Test concentrations with justification for top dose:

37, 111, 333, 1000, 3000 µg/plate in DMSO

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

other: 2-aminoanthracen, adriamycin

Details on test system and experimental conditions:

IUCLID4 Type: Ames test, Ames plate incorporation assay with and without metabolic activation, with 5 strains, investigations carried out in triplicate, positive and negative (solvent) control

Evaluation criteria:

positive
if at least one strain shows for 2 concentrationsa significant increase (p<5 %, reproducible ) over the respective negative (solvent) control or
if a positive dose effect relationship including 3 concentrations of factor 3 is shown

Statistics:

student t-test

Results and discussion

Test results

Species / strain:

S. typhimurium, other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Bacteria strain	metabol.	positive control	concentration
TA 98	without/with	Adiamycin/Aflatoxin B1	3 µg/plate / 1 µg/plate
TA 100	without/with	Adiamycin/Aflatoxin B1	3 µg/plate / 1 µg/plate
TA 1535	without/with	Sodium azide/2 -Aminoanthracene	3 µg/plate / 1µg/plate
TA 1537	without/with	2 -Nitrofluorene /2 -Aminoanthracene	3 µg/plate / 1 µg/plate
TA 1538	without/with	2 -Nitrofluorene/Aflatoxin B1	3 µg/plate / 1 µg/plate

Negative controls reacted negative.

Positive controls reacted positive.

Applicant's summary and conclusion

Executive summary:

1,4 -dichlorobenzene was investigated in accordance with OECD guidelines and under GLP conditions with regard to a possible mutagenic action on Salmonella typhimurium. The investigations were carried out as an Ames Plate Incorporation Assay with the strains Salmonella thyphimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in two independent tests per strain. The experiments comprised testing of the substance at five concentrations both without and with metabolic activation as well as positive and negative controls. All investigations were carried out in triplicate.

1,4 -dichlorobenzene did not prove to be mutagenic in the Ames test for the strains of Salmonella typhimurium tested.