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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP, non-guideline study, published data, some restrictions (e.g. no details on substance purity), acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Genotoxicity of organic chemicals frequently found in the air of mobile homes
Author:
Connor TH, Theiss JC, Hanna HA et al
Year:
1985
Bibliographic source:
Toxicol Lett. 25; 33-40.

Materials and methods

Principles of method if other than guideline:
The mutagenicity assay employed was that described by Maron and Ames (1983) using Salmonella typhimurium strains TA100 and TA98, which are DNA-repair deficient, and two additional strains, UTH8414 and UTH8413, developed by Matney (1983) which have full DNA repair capacity.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tetrachloroethlylene- Source: Eastman, KodakNo further details on the test material were reported.

Method

Target gene:
his
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
other: DNA-repair deficient
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
other: DNA-repair deficient
Species / strain / cell type:
other: UTH8414
Additional strain / cell type characteristics:
other: DNA repair capacity
Species / strain / cell type:
other: UTH8413
Additional strain / cell type characteristics:
other: DNA repair capacity
Metabolic activation:
with and without
Metabolic activation system:
S9, liver homogenate from Aroclor-induced male Sprague-Dawley rats and the necessary co-factors
Test concentrations with justification for top dose:
50, 100, 500, 1000, and 2000 μg/plate
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Migrated to IUCLID6: for TA100 without S9
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: cisplatin (for UTH8414 and UTH8413 without S9)
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (for TA98 with S9)
Details on test system and experimental conditions:
The plate incorporation assay was performed.The concentration of S9 was 100 μl/plate. Plates not receiving S9 were prepared with a similar volume (0.5 ml) of sterile buffer.The plates were incubated at 37 ºC for 48 h, at which time the number of colonies per plate was determined. The chemical to be tested was prepared immediately prior to use and diluted in DMSO.The chemical and plates were protected from exposure to light during all procedures, including incubation.
Evaluation criteria:
not reported, see Maron and Ames (1983) and Matney (1983)
Statistics:
not specified

Results and discussion

Test results
Species / strain:
other: TA98, TA100, UTH8413 and UTH8414
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:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion