Dichloro(phenyl)phosphine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Dichloro(phenyl)phosphine is not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation. [BASF, 2013]

Link to relevant study records

Reference

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: Modern OECD guideline study conducted according to GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Target gene:

The rate of induced back mutations of several bacteria mutants from histidine auxotrophy (his-) to histidine prototrophy (his+) is determined.

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

33 μg - 5 000 μg/plate (SPT)
3.3 μg - 1 000 μg/plate (PIT)

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

other: 2-aminoanthracene, N-methyl-N-nitrosoguanidine, 4-nitro-o-phenylenediamine, 9-aminoacridine

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

SPT: > 1000 µg/plate; PIT: > 100 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Under the experimental conditions of the study, the test substance Dichloro(phenyl)phosphine is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

Executive summary:

A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Contrary, using the tester strains TA 100 in the preincubation test increased numbers of revertants were observed without S9 mix or after the addition of a metabolizing system at a concentration of 333 μg/plate (factors 3.0 and 2.8, respectively). In a repeat experiment this finding was not reproduced and therefore these findings have to be regarded as biological irrelevant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

According to the results of the present study, the test substance did not lead to a biologically relevant increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in several experiments carried out independently of each other (standard plate test and preincubation assay). However, the increase in the number of his+ revertants observed in the preincubation test with the test strain TA 100 was not reproduced in a repeat experiment, and so these findings have to be regarded as biological irrelevant. Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study.

In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.

In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data or above. [BASF, 2013]

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available information is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified as mutagenic under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available information is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified as mutagenic under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).