Reaction mass of Copper,di-µ-iodotris[triphenylphosphine]di- and iodobis(triphenylphosphino)copper

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

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 471 (Ames-Test)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Iodo-tris(triphenylphosphine)copper(I)

EC Number:

454-330-9

EC Name:

Iodo-tris(triphenylphosphine)copper(I)

Cas Number:

15709-82-7

Molecular formula:

Hill formula: C54H45CuIP3 CAS formula: C54H45CuIP3

IUPAC Name:

Iodo-tris(triphenylphosphine)copper(I)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 219001
- Expiration date of the lot/batch: January 01 , 2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry, room temperature, closed container

Method

Species / strain

Species / strain / cell type:

bacteria, other: sat TA 97a, 98, 100, 102, 1535

Metabolic activation:

with and without

Metabolic activation system:

S9-Mix (rat, PB/NF induced)

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 2 ... 200 µg/plate
Concentration range in the main test (without metabolic activation): 2 ... 200 µg/plate

Vehicle / solvent:

Solvent: demineralised water

Details on test system and experimental conditions:

Specification

species: Salmonella typhimurium L T2
strains: TA 97a, TA 98, TA 100 and TA 102, TA 1535
mutations: T A97a: his06610, TA 98: hisD3052 TA 100 and TA 1535 hisG46, TA102: hisG428, TA97, TA98 and TA100 contain uvrB; TA97, TA98, TA100 and TA102 contain pKM 101 and rfa.

Origin and Culture

Salmonella typhimurium (all strains used) were obtained from Prof. Ames and stored as stock cultures at - 80°C.
Date of arrival: June. 23rd 2001 (TA 100), Jan. 29th 2001 (TA1535) and Feb. 25th, 2002 (TA 97a, 98, 102).

Results and discussion

Test results

Species / strain:

other: sat TA 97a, 98, 100, 102, 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

in 1st and 2nd experiment

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

in 1st and 2nd experiment

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Executive summary:

RESULTS

In both experiments, the test item didn't show mutagenic effects towards Salmonella typhimurium. A concentration-based relationship could consequently not be observed, either. The test item didn't show any signs of cytotoxicity. The test item is considered as "not mutagenic under the test conditions".

DISCUSSION

The test item is considered not mutagenic. No toxic effects could be determined.

The confirmation tests of the genotype didn't show any irregularities.

In the first experiment, the titre of two strains was lower than the demanded value. As the spontaneous revertants lay within the normal range, this was stated as uncritical. The positive controls didn't evoke as many mutations as given by Prof. Ames, but the revertants were definitely increased in comparison with the negative controls, as well as showing mutagenic potential of the diagnostic mutagenes. The number of spontaneous revertants lay lower than given in the literature by Prof. Ames; however, compared with the historical values of LAUS GmbH, they were

within the normal range. For these reasons, the result of the test is considered valid.

As the test item is poorly soluble in water and other solvents, no analytical method could be developed. Therefore the content of the test item in the test solution could not be determined and the treatments tested were given as nominal concentrations.