Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 000 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
45 211 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
45 211 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
36 739.74 mg/kg soil dw
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

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 the equilibrium assumption method (PNECsediment-freshwater, PNECsediment-marine-water and PNECsoil). The PNECair and PNECsecondary poisoning are not considered as relevant based on the chemical structure of the registered substance. 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 calcium sulfonate read across substances are available for evaluating biodegradation, metabolism and toxicity of the calcium sulfonate target substance (C10-C14) to aquatic vertebrate and invertebrate species.

None of the calcium read across substances was found to be readily biodegradable when tested following OECD Guideline 301D (Douglas, 1989). Thus, a rapid biotic degradation of the calcium sulfonate target substance (C10 -C14) in aquatic environment is not expected.

Toxicity to fish

The calcium sulfonate read-across substance (CAS 115733-09-0) was used in an experiment according to OECD Guideline 203 with Oncorhynchus mykiss as test organism (Goodband 2005; key study). The NOELR (96h) is reported as 100 mg/L WAF and the LL50 (96h) is > 100 mg/L WAF. Cyprinodon variegatus served as saltwater fish species in experiments in order to determine the toxicity potential of the calcium sulfonate read-across substances CAS 70024-71-4 and CAS 61789-86-4 (Nicholson, 1986). In both limit tests, the LL50 (96h) is > 10000 mg/L WAF with a corresponding NOELR of 10000 mg/L WAF. The toxicity data available for several acute fish studies (quantified as Water Accommodated Fractions (WAFs)) demonstrate that the substance is not toxic to fish even at the highest test substance concentrations tested. The weight-of-evidence indicate that the lower NOECs for O. mykiss are not an indicator of toxicity per se, but are the result of dose selection. Long-term investigations are not triggered based on the observations in acute tests.

Toxicity to aquatic invertebrates

The calcium sulfonate read-across substance(CAS 115733-09-0) was used in an experiment conducted in accordance to US-EPA Guideline OTS 797 -1300 with Daphnia magna (Ward, 1993). As result, an EL50 (48h) > 1000 mg/L WAF is reported.The revealed results demonstrate that the substance is not toxic to daphnids even at the highest test substance concentrations tested.Long-term investigations are not triggered based upon the chemical safety assessment for freshwater invertebrates. In a further key study with Sulphonic acids, petroleum, calcium salts (CAS 61789-86 -4), Daphnia magna were exposed also under static conditions for 48 hours following OECD Guideline 202 (Goodband, 2005). Beside control, Daphnids were exposed to a single nominal test substance concentration of 100 mg/L WAF for 48 hours. No immobilisation was observed in any daphnids at 100 mg/L nominal WAF loading rate. The EL50(48h) is considered as > 100 mg/L.

Toxicity to aquatic algae

The calcium sulfonate read-across substance (CAS 115733-09-0) was tested at nominal concentrations of 100, 300 and 1000 mg/L as WAF loading rates under static conditions (study according to EPA OTS 797.1050 by Ward, 1994). After 72 hours, biomass measurements were 80 %, 62 % and 70 % of the control at 100, 300 and 1000 mg/L WAF, respectively. At 96-hours, biomass measurements were 70 %, 66 % and 88 % of the control at 100, 300 and 1000 mg/L WAF, respectively. Based on these findings, the ErL50(72h), ErL50(96h), EbL50(72h) as well as the EbL50(96h) values are > 1000 mg/L. The NOEL amounts to 1000 mg/L WAF for each sampling period.

In a 72 hour toxicity study, the cultures of the green algae (Scenedesmus subspicatus) were exposed to sulphonic acids, petroleum, calcium salts (CAS 61789 -86 -4) at nominal concentrations of 0 and 100 mg/L nominal WAF loading rate under static conditions. The test was performed by Mead (2005) in accordance with the guideline OECD Guideline 201 (Alga, Growth Inhibition Test). The EL50 based biomass was > 100 mg/L and the EL50 based on growth rate was > 100 mg/L. There were no compound related phytotoxic effects.

Toxicity to aquatic microorganisms

The calcium sulfonate read-across substance CAS 61789-86-4 was used in an experiment according to OECD 209 by Goodrich (1994). The study design comprised five nominal exposure concentrations: 1, 10, 100, 1000 and 10000 mg/L, a duplicate control group; and an assessment of the sensitivity of the inoculum used in the test to a reference toxicant (3,5-dichlorophenol).

No toxicity was observed, hence EC50 amounts to > 10000 mg/L. The corresponding NOAEC is 10000 mg/L.

Conclusion on classification

The calcium sulfonate target substance (C10-C14) has not to be classified and labelled according to Regulation (EC) No 1272/2008.