Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
10 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

According to Article 13 "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 group concept is applied to the category members of the Dimerised Fatty Acids and it Derivatives (sub-category 2 predominantly oligomers) data will be generated from a representative sub-category member to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

Classification related key information for Fatty acids, C18-unsaturated, dimers (CAS No. 61788-89-4) as a member of Sub-category 2 of the Dimerised Fatty Acids and its derivatives:

Biodegradation in water: < 10 % after 28d (OECD 301B), not rapidly biodegradable

LogKow: >4 (expert judgment)

Acute toxicity:

- to fish: LC50 (96h) (Danio rerio) = No observed toxicological effects up to the water solubility limit (< 0.12 mg/L, limit of detection)

- to Algae ErC50 (72h) (Selenastrum capricornutum) = No observed toxicity up to the water solubility limit (< 0.12 mg/L, limit of detection)

- to Crustacea EC50 (48h) (Daphnia magna) = No observed toxicological effects up to the water solubility limit (<0.12 mg/L, limit of detection)

Chronic toxicity:

- to fish: NOEC ≥ 0.85 mg/L (highest mean measured concentration tested) (Danio rerio) (based on read across data)

- to Algae (72 h) NOEC (Selenastrum capricornutum)

: No chronic toxicity was observed up to the water solubility (< 0.12 mg/L, limit of detection)

- to Crustacea NOEC (21d) = no data available

Classification justification according to CLP

Based on the data above, members of the sub-category 2 of the dimerised fatty acids are considered to be not rapidly degradable. No acute aquatic toxicity was observed up to the water solubility limit (<0.12 mg/L, limit of detection) for fish, algae and Daphnia. Valid chronic toxicity data are available for fish (Danio rerio): NOEC (28 d) of ≥ 0.850 mg/L (highest mean measured concentration tested). Therefore, no classification is required for Fatty acids, C18-unsaturated, dimers (CAS No. 61788-89-4) according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).

Classification justification according to DSD

Based on the data above, all sub-category 2 members of the dimerised fatty acids are considered to have a low potential for bioaccumulation, however, they are considered not readily biodegradable. No acute or chronic aquatic toxicity was observed up to the water solubiltiy limit (< 0.12 mg/L).

Therefore no classification is required for Fatty acids, C18-unsaturated, dimers (CAS No. 61788-89-4) according to Directive 67/548/EEC.