Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.2 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.179 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.02 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.711 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:
1.305 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

According to Article 13 of Regulation (EC) No 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of Substances", Information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”. Since the read-across concept is applied for selected endpoint, data will be generated from a representative source substance to avoid unnecessary animal testing. Additionally, once the read-across concept is applied, substances will be classified and labelled on this basis.

Brief description of the data relevant for classification

Degradation:

Biodegradation: readily biodegradable: 62.5% to 88% after 28 d (OECD 301 C and F); read-across

Bioaccumulation:

Low potential for bioaccumulation.

Aquatic acute toxicity

Fish:

·        RA CAS 1338-41-6: LL50 (96 h, Oryzias latipes) > 1000 mg/L (nominal, WAF)

·        RA CAS 1338-39-2: LC50 (96 h, Danio rerio) > 100 mg/L (nominal)

·        RA CAS 9005-64-5: LL50 (96 h, Danio rerio) > 100 mg/L (nominal)

Aquatic invertebrates:

·        RA CAS 1338-41-6: EL50 (48 h, Daphnia magna) >1000 mg test item/L (nominal)

·        RA CAS 1338-39-2: LL50 (48 h, Acartia tonsa) = 452.84 mg test item/L (nominal, WAF)

Algae:

·        RA CAS 1338-41-6: EL50 (72 h, Pseudokirchneriella subcapitata) >1000 mg/L (nominal, WAF, based on growth rate)

·        RA CAS 1338-39-2: EL50 (72 h, Skeletonema costatum) = 17.89 mg/L (nominal, WAF, based on growth rate)

·        RA CAS 9005-64-5: EL50 (72 h, Pseudokirchnerella subcapitata) = 58.84 mg/L (nominal, WAF, based on growth rate)

Aquatic chronic toxicity

Fish: no data available

Aquatic invertebrates:

·        RA CAS 1338-41-6: NOELR (21 d, Daphnia magna) ≥ 16 mg/L (nominal, based on cumulative number of juveniles produced per adult

·        RA CAS 9005-64-5: NOELR (21, Daphnia magna) = 10 mg/L (nominal, WAF)

Algae:

·        RA CAS 1338-41-6: NOELR (72 h, Pseudokirchneriella subcapitata) = 560 mg/L (nominal, WAF, based on growth rate)

·        RA CAS 1338-39-2: NOELR (72 h, Skeletonema costatum) ≥ 10 mg/L (nominal, WAF, based on growth rate)       

·        RA CAS 9005-64-5: EL10 (72 h, Pseudokirchnerella subcapitata) = 19.05 mg/L (nominal, WAF, based on growth rate)

Conclusion on classification

CLP:

Based on the data above, sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated) is considered to be rapidly biodegradable. The acute aquatic toxicity L(E) C(L)50 values are ≥17.89 mg/L. Chronic toxicity data are additionally available for aquatic invertebrates and algae. The lowest NOELR value is 10 mg/L. Therefore, sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated) does not need to be classified and labelled for acute or long-term hazards to the aquatic environment according to the 6th ATP of the Regulation (EC) No 1272/2008 (CLP).