4,4',4''-triaminotrityl alcohol

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

In Vitro Mutagenicity Assays of Chemical Carcinogens and Related Compounds With Salmonella typhimurium

Author:

Vincent F. Simmon

Year:

1979

Bibliographic source:

Journal of the National Cancer Institute, Volume 62, Issue 4, 1 April 1979, Pages 893–899,

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mention below

Principles of method if other than guideline:

To evaluate the mutagenic potential of Pararosaniline in Salmonella typhimurium strains by Reverse bacterial mutation assay

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4,4',4''-triaminotrityl alcohol

EC Number:

207-395-0

EC Name:

4,4',4''-triaminotrityl alcohol

Cas Number:

467-62-9

Molecular formula:

C19H19N3O

IUPAC Name:

tris(4-aminophenyl)methanol

Test material form:

solid: crystalline

Details on test material:

- Name of test material : 4,4',4''-Triaminotrityl alcohol
- Molecular formula : C19H19N3O
- Molecular weight : 305.379 g/mol
- Smiles notation : C(c1ccc(N)cc1)(c1ccc(N)cc1)(c1ccc(N)cc1)O
- InChl : 1S/C19H19N3O/c20-16-7-1-13(2-8-16)19(23,14-3-9-17(21)10-4-14)15-5-11-18(22)12-6-15/h1-12,23H,20-22H2
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material : 4,4',4''-Triaminotrityl alcohol
- Molecular formula : C19H19N3O
- Molecular weight : 305.379 g/mol
- Smiles notation : C(c1ccc(N)cc1)(c1ccc(N)cc1)(c1ccc(N)cc1)O
- InChl : 1S/C19H19N3O/c20-16-7-1-13(2-8-16)19(23,14-3-9-17(21)10-4-14)15-5-11-18(22)12-6-15/h1-12,23H,20-22H2
- Substance type: Organic
- Physical state: Solid

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA1535, TA1536, TA1537, TA1538, TA98, and TAI00

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

other: All strains are uvrB-deficient (to reduce the repair of chemically induced lesions in the DNA) and are rfa In addition strainsTA98 and TAI00 contain the plasmid pKMIOl, which makes them more sensitive than their parent strains.

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 -a metabolic activation system prepared from the livers of randomly bred Sprague-Dawley rats that had been pretreated with Aroclor1254.

Test concentrations with justification for top dose:

0 and 250 ug/plate

Vehicle / solvent:

Yes, but not specified

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

not specified

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 12 hour
Other; The strains were checked periodically for relevant genetic markers and for rfa by crystal violet sensitivity; T A98 and T AI00 were checked for ampicillin resistance.

Rationale for test conditions:

Not specified .

Evaluation criteria:

The numbers of Histidine-independent revertants for each Salmonella typhimurium strain were taken from the linear portion of dose-response curves after the background was subtracted. The range of spontaneous revertants was 25-55 for TA1535, 7-25 for TA1537, 10-30 for TA1538, 30-60 for TA98, and 100-180 for TA100.A positive response was defined as a reproducible, dose-related increase in the number of revertants. Usually, a chemical was mutagenic in more than one strain.

Statistics:

Mean ±standard deviation was observed.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA1535, TA1536, TA1537, TA1538, TA98 and TAI00

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: No mutagenic effect were observed.

Applicant's summary and conclusion

Conclusions:

Pararosaniline (467-62-9) was evaluated for its mutagenic potential in Salmonella typhimurium strains TA1535, TA1536, TA1537, TA1538, and TA98and TAI00 by bacterial reverse mutation assay. The test results were considered to be negative in the presence and absence of S9 mix.

Executive summary:

Pararosaniline was assessed for its possible mutagenic potential. For this purpose bacterial reverse mutation assay was performed on Salmonella typhimurium strains TA1535, TA1536, TA1537, TA1538, TA98, and TAI00.The test material was exposed at the concentration of 0 and 250ug /plate byplate incorporation Method.The test material was exposed in the presence and absence of metabolic activation.The numbers of Histidine-independent  revertants for each Salmonella  typhimurium  strain  were taken from the linear  portion  of dose-response curves after  the  background was  subtracted. The  range  ofspontaneousrevertantswere as per the control. No mutagenic effect was observed. Therefore Pararosaniline was considered to be non mutagenic in Salmonella typhimurium strains TA1535,  TA1536, TA1537, TA1538, TA98 and TAI00. Hence the substance cannot be classified as gene mutant in vitro.