Dibutyl hydrogen phosphate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1995

Reference 2

Reference Type:

publication

Title:

Relevance of chemical structure and cytotoxicity to the induction of chromosome aberrations based on the testing results of 98 high production volume industrial chemicals

Author:

Kusakabe H, Yamakage K, Wakuri S, Sasaki K, Nakagawa Y, Watanabe M, Hayashi M, Sofuni T, Ono H, Tanaka N

Year:

2002

Bibliographic source:

Mut Res 517, 187-198 (2002)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Principles of method if other than guideline:

Ames test with S.typhimurium TA 100, TA 1535, TA 98, TA 1537, E.coli WP2 uvrA; plate incorporation assay

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl hydrogen phosphate

EC Number:

203-509-8

EC Name:

Dibutyl hydrogen phosphate

Cas Number:

107-66-4

Molecular formula:

C8H19O4P

IUPAC Name:

dibutyl hydrogen phosphate

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

rat liver S-9 mix, induced with phenobarbital and 5.6-benzoflavone

Test concentrations with justification for top dose:

0, 4.882, 9.755, 19.53, 39.06, 78.12, 156.2 µg/plate

Vehicle / solvent:

acetone

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: -S9, AF-2 (TA100, WP2, TA98), sodium azide (TA 1535) and9-aminoacridine (TA1537); +S9, 9-aminoanthracen (all strains)

Details on test system and experimental conditions:

Ames test

Results and discussion

Test results

Key result

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:

toxicity was observed at 156.2 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

see result Tables 1 and 2 - attached

Any other information on results incl. tables

Dibutyl hydrogen phosphate was negative in Salmonella typhimurium TA100, TA98, TA1535, TA1537 and Echerichia coli WP2 uvrA with and without metabolic activation.

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

Executive summary:

An Ames test with S.typhimurium strains TA 100, TA 1535, TA 98, TA 1537, and E.coli WP2 uvrA was conducted with dibutyl hydrogen phosphate according the guidelines for screening mutagenicity testing of chemicals (Japan).

Dibutyl hydrogen phosphate was tested in concentrations of 4.882 to 156.2 µg/plate. Toxicity was observed at 156.2 µg/plate, with and without metabolic activation. The test results were negative in all strains, with and without metabolic activation.