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Toxicological information

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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Bacterial reverse mutation assay (OECD 471): negative with and without metabolic activation Mammalian chromosome aberration test, human lymphocytes (OECD 473): negative with and without metabolic activation
Link to relevant study records
in vitro gene mutation study in bacteria
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessed after consultation with the relevant Authority. Data migrated from NONS (67/548/EEC notification) files provided by Authority contained insufficient information.
according to guideline
other: OECD 471 and 472
according to guideline
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
No further information was provided in the SNIF file.
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
bacteria, other: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50-5000 ¿g/plate.
Concentration range in the main test (without metabolic activation): 50-5000 ¿g/plate.
Vehicle / solvent:
Solvent: DMSO
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Species / strain:
other: as specified above
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
5000 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Observations: no increase in the number of revertant colonies.
Remarks on result:
other: all strains/cell types tested
Migrated from field 'Test system'. Remarks: preliminary test and main test
Interpretation of results (migrated information):

According to DSD 67/548/EEC, the substance is not classified as mutagenic.
According to Regulation (EC) No 1272/2008, the substance is not classified as mutagenic.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

There are three in vitro studies available. These studies assesses the mutagenicity of 2,3 -bis(2 -mercaptoethyl)thio)-1 -propanethiol in bacteria, clastogenicity in a mammalian cell line and mutagenicity in a human cell line.


The mutagenic effect in bacteria was investigated in a bacterial reverse mutation assay (Ames test) with 5 standard strains (Mitsui 1993, SNIF#001 -4.3.10 -01). In this study the Salmonella typhimurium TA98, TA100, TA1535 and TA1537, and Eschericia coli WP2 uvrA strains were exposed to the test substance with or without metabolic activation (S9 -mix). The concentration range was 50 - 5000 µg/plate both and without metabolic activation. Cytotoxic effects were observed at 5000 µg/plate with and without S9 -mix. Under the conditions of the study the test substance did not induce gene mutations.


An in vitro chromosome aberration test (Mitsui 1993, SNIF#001-4.3.28 -01) was performed in human lymphocytes to assess the clastogenic potential of 2,3 -bis((2 -mercaptoethyl)thio)-1-propanethiol in mammalian cells. The cells were exposed to concentrations in the range 20 - 80 µg/mL for 3 hours with metabolic activation (S9 -mix), and in the range 10 - 40 µg/mL for 3, 24 and 48 hours without metabolic activation. Cytotoxicity was observed at concentrations >40 µg/mL and > 10 µg/mL with and without S9 -mix, respectively. Under the conditions of the study, 2,3 -bis((2 -mercaptoethyl)thio)-1 -propanethiol did not induce biologically significant chromosomal aberrations in the human lymphocytes, and therefore the substance is not clastogenic.

Justification for selection of genetic toxicity endpoint
Key study. Ames study was selected, however other genotoxic endpoints are equially valuable.

Justification for classification or non-classification