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Toxicological information

Genetic toxicity: in vitro

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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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.