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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The substance has no structural alerts for mutagenicity, and a large database of performed studies indicate that o-TSA does not have genotoxic properties.

 

The table below lists all available data, including from literature.

Type of test

Test system

Doses

Result

Reference 

Bacterial test

Gene mutation assay

S. typhimurium strains TA98, TA100, TA1535, TA1537, TA1538; Saccharomyces cerevisiae D4

Up to 1000 ug/plate

Negative (+/- S9)

Proprietary, Litton Bionetics, 20838, 1978

Ames test (reverse mutation)

S. typhimurium (TA98, TA100, TA1535, TA1537) E. coli (WP2uvr A)

Up to 5000 ug/plate

Negative (+/- S9)

MHW, Japan: 1999

Ames test (reverse mutation)

S. typhimurium (TA1535, TA100, TA98, TA1537)

Up to 1000 ug/plate

Negative (+/- S9)

Stolts et al.: 1977

Ames test (reverse mutation)

S. typhimurium (TA1530, TA1535, TA1537, TA1538, TA100, TA98)

Up to 4 x 10-2 mol/plate

Negative (+/- S9)

Poncelet et al.: 1979

Ames test (reverse mutation)

S. typhimurium (TA1535, TA100, TA1538, TA98, TA1537)

Up to 18000 ug/plate

Weakly positive: TA98 (+ S9)
Negative: TA98 (-S9) and other strains (+/- S9)

Eckhardt et al.: 1980

Ames test (reverse mutation)

S. typhimurium (TA98, TA 100, TA 1535, TA1537)

Up to 18000 ug/plate

Negative (+S9)

Herbold: 1981

Ames test (reverse mutation)

S. typhimurium (TA1535, TA1538, TA98, TA100)

Up to 2500 ug/plate

Negative (+S9)

Ashby et al.: 1978

Non-bacterialin vitrotest

forward mutations (TK locus)

mouse lymphoma L5178Y cells

Up to 1712 μg/mL

Negative (+/- S9)

Proprietary,

TNO Triskelion, V20203/05, 2013

Chromosomal aberration test

CHL cells

Up to 3000 ug/mL

Negative (+/- S9)

MHW, Japan:1999

Ouabain-resistant mutation assay

Human RSa cells

Up to 1800 ug/mL

Negative (-S9)

Suzuki & Suzuki: 1988

Chromosomal aberration test

CHO-K1 cells

Up to 400 ug/mL

Negative (-S9)

Masubuchi et al.: 1978

In vivotest

Mammalian spot test

Mouse

1000 mg/kg bw (oral)

Inconclusive

Fahrig: 1982

Micronucleus assay

Mouse

1026 mg/kg bw (by gavage)

Negative

Eckhardt et al.: 1980

Micronucleus assay

Mouse

Up to 1026 mg/kg bw (i.p.)

Negative

Eckhardt et al.: 1980

 

References:

·   Proprietary: Litton Bionetics (Jagannath, D. R. & Brusick, D.), 20838, 1978.

·   Proprietary: TNO Triskelion, V20203/05, 2013

·   Ashby, J. et al. (1978) Fd. Cosmet. Toxicol., 16, 95-103.

·   Eckhardt, K. et al. (1980) Toxicology Letters, 7, 51-60.

·   Fahrig, R. (1982) Mutat. Res., 103, 43-47.

·   Herbold, B.A. (1981) Mutat. Res., 90, 365-372.

·   Masubuchi, M. et al. (1978) Mutat. Res., 54, 242-243.

·   MHW, Japan (1999) Ministry of Health and Welfare, Toxicity Testing Reports of Environmental Chemicals, 7, 125-160.

·   Poncelet, F. et al. (1979) Fd. Cosmet. Toxcol., 17, 229-231.

·   Stolts, D. R. et al. (1977) J. Environ. Pathol. Toxicol., 1, 139-146

·   Suzuki, H. & Suzuki, N. (1988) Mutat. Res., 209, 13-16.


Justification for selection of genetic toxicity endpoint
No one specific study is selected. All key studies for this endpoint addressing bacterial mutagenicity, mammalian mutagenicity and mammalian clastogenicity were all negative.

Short description of key information:
The substance has no structural alerts for mutagenicity, and a large database of performed studies, including high quality GLP studies according OECD guidelines covering in vitro bacterial mutagenicity, mamalian mutagenicity and clastogenicity, as well as in vivo micronucleus studies, indicate that p-TSA does not have genotoxic properties.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance has no structural alerts for mutagenicity, and available studies covering bacterial mutagenicity, mammalian mutagenicity and mammalian clastogenicity all indicate that o-TSA does not have genotoxic properties.