4,4',4''-triaminotrityl alcohol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Reference

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.

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

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

Target gene:

Histidine

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Genotoxicity In-vitro

Various publications were reviewed to determine the mutagenic nature of 4,4',4''-Triaminotrityl alcohol ;Other name; Pararosaniline (467-62-9). The studies are as mentioned below:

Experimental study on genetic toxicity in vitro was conducted by Vincent F. Simmon (Journal of the National Cancer Institute, 1979) to determine the mutagenic nature of target substance Pararosaniline (467-62-9) by AMES test . 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  of spontaneous revertants were 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.

Supporting experimental study on genetic toxicity in vitro was conducted by Vincent F. Simmon (Journal of the National Cancer Institute, 1979) to determine the mutagenic nature of target substance Pararosaniline (467-62-9) by Liquid incubation assay. Pararosaniline was assessed for its possible mutagenic potential. For this Liquid incubation assay was performed on Salmonella typhimurium strains TA1535 and TAI00.The test material was exposed at the concentration of 0 and0.78µmolebyplate 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 and TAI00. Hence the substance cannot be classified as gene mutant in vitro.

Another supporting experimental study on genetic toxicity in vitro was conducted by J. Mirsalis et al.( Abstracts of the fifteenth annual meeting of the environmental mutagen society held at San Antonio, Texas March 3–6, 1983 ,Environmental and Molecular Mutagenesis,19 83) to determine the mutagenic nature of target substance Pararosaniline (467-62-9). Genetic toxicity in vitro for Para- Rosaniline was assessed for its possible mutagenic potential. For this purpose Unscheduled DNA assay was performed. Hepatocytes from male Fischer-344 rats were incubated with3H-TdR along with test substance at the test concentration of2.2ug/ml. Positive and negative controls were used .Unscheduled DNA synthesis was measured by quantitative autoradiography as net grains/nucleus (NG). No mutagenic effects were observed in test substance as compared to the value of positive and negative control. Therefore Para- Rosaniline was considered to be non mutagenic for Unscheduled DNA assay. Hence the substance cannot be classified as gene mutant in vitro

 In another Another supporting experimental study on genetic toxicity in vitro was conducted by S.R. Haworth et al.( Abstracts of the twelfth annual meeting of the environmental mutagen society, Environmental Mutagenesis,19 81) to determine the mutagenic nature of target substance Pararosaniline (467-62-9). Pararosaniline was assessed for its possible mutagenic potential. For this purpose bacterial reverse mutation assay was performed on Salmonella typhimurium strains TA98 and TAI00.TheB6C3F1mice were fed with the test material. The test substance was exposed to the plates (Salmonella strain TA 98 and TA 100) in the form of urine collected from male and female mouse. The test material was exposed at the concentration of 0.75 ml, 0.5 ml, 0.2 ml and 0.05 ml of neat urinebyplate incorporation Method.The test results were considered to be positive in the presence and absence. Urine from p-rosaniline treated mice exhibited mutagenic activity on TA98 and Tal00 in the male mouse and on TA98 alone in the female mouse. The mutagenic activity was increased in the presence of S9. Therefore Pararosaniline was not considered to be mutagenic in Salmonella typhimurium strains TA98 and TAI00 in the presence and absence of S9. But as the detail study is not available, the test results were considered to be ambiguous. Hence test substance cannot be classified as mutagenic.

 

Based on the data available for the target chemical from various detailed experimental study , it is concluded that 4,4',4''-Triaminotrityl alcohol ;Other name; Pararosaniline (467-62-9)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Thus based on the above annatation and CLP criteria for the target chemical from various detailed experimental study , it is concluded that 4,4',4''-Triaminotrityl alcohol ;Other name; Pararosaniline (467-62-9)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.