Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.041 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.41 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.004 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
8 000 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
380.62 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
38.06 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
308.96 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
6.67 mg/kg food
Assessment factor:
300

Additional information

Derivation of PNECs

The PNECs for the different compartments are calculated either by application an assessment factor (PNECfreshwater, PNECmarine water, PNECintermittent release and PNECstp) or using theequilibrium assumption method(PNECsediment-freshwater, PNECsediment-marine-water and PNECsoil). The PNECair is not considered as relevant based on the chemical structure and intrinsic properties of the registered substance. Secondary exposure of mammals and birds is not expected, however, the PNECsecondary poisoning was derived based on the mammalian data available. The utilized procedures are described in detail in the ECHA REACH Guidance of May 2008, Chapter R.10 ("Characterisation of dose [concentration]-response for environment").

Environmental classification and labeling

Experimental results of 1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-nonanethiol (CAS 91648-65-6) and its read-across substances 1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-dodecanethiol (No CAS, no EC) are available for evaluating biodegradation, metabolism and toxicity towards aquatic vertebrate and invertebrate species. No long-term data are available (and triggered), thus reliable acute toxicity data for three trophic levels (i.e. fish, daphnids and algae) are the basis for the chemical safety assessment of 1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-nonanethiol (CAS 91648-65-6).

The target substance was found to be not readily biodegradable (Katsuura, 1990), which is supported by the outcomes of experiments using the read-across substance. The most critical result was found in the acute test with Daphnia magna (OECD 202; Vryenhoef, 2012), revealing an EL50(48h) of 41 mg/L WAF. Although the target substance is not bioaccumulative, since a bioconcentration factor (BCF) of 15.7 L/kg was predicted with the reliable QSAR program BCFBAF v3.01 (Chemservice S.A., 2013), classification and labelling criteria in accordance to the ATP (Adaption to Technical Process) 2 of Regulation (EC) 1272/2008 with respect to environmental hazards are fulfiled.

Conclusion on classification

1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-nonanethiol (CAS 91648-65-6) has to be classified and labeled in accordance to Regulation (EC) No 1272/2008 of the European Parliament and of the Council. The classification is "Aquatic Chronic 3" with Hazard statement 412 (H412; Harmful to aquatic life with long lasting effects) and Precautionary statements P273 (Avoid release to the environment) and P501 (Dispose of contents/container in accordance with local/regional/national/international regulations). No pictogram and no signal word have to be used for labelling.