[No public or meaningful name is available]

Ecotoxicological Summary

Hazard for aquatic organisms

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

101.3 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

66.7 mg/kg food

Assessment factor:

300

Additional information

Secondary poisoning

 

NOECmammal, food, chr = NOAEL mammal, oral, chr * CONVmammal

NOECmammal, food, chr = 10E-03 [kg.kg bw^-1.d^-1] * 20 [kg bw.d^–1.kg food^–1]

NOECmammal, food, chr = 2E-02 [kg.kgfood^–1]

 

PNECoral = NOECmammal, food, chr / AForal

PNECoral =2E-02 [kg.kgfood^–1]/300

PNECoral = 0.000067 [kg.kgfood^-1]

PNECoral = 66.7 [mg.kgfood^-1]

No toxicity on reproduction of Daphnia magna  was observed in a saturated solution (concentration of 5 µg/L, indicating that any effect concentration, including the EC10, is higher than the measured water solubility of the SymMollient S (water solubility: 3.5 µg/L hexadecyl nonanoate, 1.7 µg/L octadecyl nonanoate). Thus, only an unbounded NOEC value could be derived from the chronic toxicity test with Daphnia. However,the use of unbounded NOEC values is typically not recommended. Furthermore, available acute toxicity data (fish), clearly show the lack of toxicity up to the measured water solubility of SymMollient S. Since, the LC50 fish and the EC10 daphnia are above water soluble levels of SymMollient S (5µg/L at 25°C/pH 6), a PNEC is not derived.

 

Furthermore, the substance is considered readily biodegradable since 93% degraded in 28 days by meeting the criteria of the 10 day window. The calculated logPow is approx. 11.7 (mean value of both components). According ECHA guidance on information requirements and chemical safety assessment - chapter R.11: PBT assessment, May 2008), “at logPow values between 4 and 5, log BCF increases linearly with logPow. This linear relationship is the basis for the B screening criterion of logPow > 4.5. However, at very high logPow(>6), a decreasing relationship between the two parameters is observed. Apart from experimental errors in the determination of BCF values for these very hydrophobic chemicals, reduced uptake due to the increasing molecular size may play a role as well. Moreover, the experimental determination of logPow for very hydrophobic chemicals is normally also very uncertain due to experimental difficulties (...). The aquatic BCF of a substance is probably lower than 2000 L/kg if the calculated logPow is higher than 10.”Thus, it can be assumed that the BCF of SymMollient S is lower than 2000 L/kg. In addition, the theoretical BMF (biomagnification factor) is 1 for organic substances with a logPow >9. For further information please refer to the CSR - PBT, vPvB assessment

 

Taking into account the following characteristics of SymMollient S:

 

·        the water solubility of 5 µg/L ,

·        aquatic acute and chronic toxicity > water solubility

·        the readily biodegradability,

·        the estimated BCF of < 2000 L/kg, and

·        the theoretical BMF (biomagnification factor) of 1,

 

it is assumed that the substance does not have a high potential to bioaccumulate.

 

Conclusion on classification

The substance does not need to be classified according to regulation (EC) no. 1272/2008 and is not considered as being hazardous for the environment in the sense of regulation (EC) 1907/2006.

Since the substance is not classified in accordance to regulation (EC) 1272/2008 neither an exposure assessment nor a risk characterisation are required in the sense of regulation (EC) 1907/2006.