Tris(2-chloroethyl) phosphate

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted as part of the USA National Toxicology Program.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Minor

Principles of method if other than guideline:

Essentially OECD 471

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2-chloroethyl) phosphate

EC Number:

204-118-5

EC Name:

Tris(2-chloroethyl) phosphate

Cas Number:

115-96-8

Molecular formula:

C6H12Cl3O4P

IUPAC Name:

tris(2-chloroethyl) phosphate

Details on test material:

Not specified

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced Sprague-Dawley rat or Syrian hamster liver

Test concentrations with justification for top dose:

5 concentrations, up to limit of toxicity/solubility (did not exceed 3,333 mcg/plate)

Vehicle / solvent:

Buffer or S9 mix

Details on test system and experimental conditions:

Incubation for 20 minutes at 37 degC prior to the addition of soft agar supplemented with l-histidine and d-biotin. Subsequent plating on minimal
glucose plates. Incubation continued for an additional 48 hours.
Each test consisted of triplicate plates of concurrent positive and negative controls and at least 5 concentrations of test material.

Evaluation criteria:

Positive response defined as a reproducible, dose-related increase in histidine-dependent (revertant) colonies in any one strain/activation
combination. An equivocal response defined as an increase in revertants which was not dose-related, not reproducible, or of insufficient magnitude to support a determination of mutagenicity. Negative response obtained when no increase in revertant colonies was observed following treatment.

Statistics:

Not specified

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Negative in the reverse mutation assay in vitro when tested in Salmonella typhimurium strains TA100, TA1535, TA1537 and TA98 in a preincubation protocol, with and without metabolic activation.