Copper chloride

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: GLP guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Reference 2

Reference Type:

publication

Title:

Copper Monochloride CAS No: 7758-89-6, Final 10/2006

Author:

OECD SIDS

Year:

2006

Bibliographic source:

INCHEM 2009

Report date:

2006

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:

Copper chloride

EC Number:

231-842-9

EC Name:

Copper chloride

Cas Number:

7758-89-6

Molecular formula:

Cl Cu

IUPAC Name:

λ¹-copper(1+) chloride

Details on test material:

- Name of test material (as cited in study report): Copper monochloride (CuCl)
- Analytical purity: 97%
- Lot/batch No.: Sigma-Aldrich corporation, Lot No. 17119BO

Method

Target gene:

his, trp

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium (strains TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli (strain WP2 uvrA)

Metabolic activation:

with and without

Metabolic activation system:

- Species and cell type: Rat (Sprague Dawley strain), male, liver - Quantity: 5 % S9 mix induced with Aroclor 1254

Test concentrations with justification for top dose:

3.7, 11.1, 33.3, 100, 300, 1000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: sterile distilled water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

sterile distilled water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-Nitrofluorene, Sodium azide, 9-Aminoacridine, 4-Nitroquinoline and 2-Aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
- no data

DURATION
- no data

NUMBER OF REPLICATIONS:
- Number of replicated: one
- Frequency of Dosing: 3 plates/dose

NUMBER OF CELLS EVALUATED:
- no data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:

OTHER:
Description of follow up repeat study: Dose range finding experiment was carried out using dose levels with 5-fold intervals of 1.6, 8, 40, 200, 1000
and 5000 μg/plate both in the absence and in the presence of metabolic activation system.

Evaluation criteria:

Criteria for evaluating results: The number of revertant colonies increased significantly in at least one strain at one or more concentrations or the data
set showing a dose related correlation.

Statistics:

Dunnett’s test

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: With metabolic activation: at above 300 µg/plate (TA 98, TA 100 and TA 1537, E. coli WP2 uvrA); Without metabolic activation: at 1,000 g/plate (TA 98, TA 100 and TA 1537)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

High statistical significance was only observed in positive control groups.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

CL-Freetext:
No mutation in the Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) and Escherichia coli (strain WP2 uvrA) occurred with copper monochloride.