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:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Justification for 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 (read-across approach), 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 category concept is applied to the polyol esters, data gaps will be filled by interpolation, as part of a read across approach from a representative category member(s) to avoid unnecessary animal testing. Additionally, once the category concept is applied, substances will be classified and labelled on this basis.

Brief description of the data relevant for classification

Degradation

Biodegradation:                   Readily biodegradable: 93.1% based on CO2 evolution (OECD 301 B)

Bioaccumulation

Expert statement:                 Bioaccumulation is expected to be low.

Aquatic acute toxicity

For fish:                               96 h, LC50 (Oryzias latipes): no effects up to the limit of water solubility (< 0.05 mg/L, purified water); read-across

For aquatic invertebrates:     no data available

For algae/aquatic plants:       72 h, ErC50 (Pseudokirchneriella subcapitata): no effects up to the limit of water solubility (< 0.05 mg/L, purified water); read-across

Aquatic chronic toxicity

For fish:                                no data available

For aquatic invertebrates:      21d, NOEC (Daphnia magna): >= 0.0019 mg/L; read-across

For algae/aquatic plant:         72 h, NOErC (Pseudokirchneriella subcapitata): no effects up to the limit of water solubility (< 0.05 mg/L, purified water); read-across

Conclusion on classification

CLP:

Based on the data above, 2,2-dimethyl-1,3-propanediyl dioctanoate is considered to be rapidly degradable. The acute aquatic toxicity L(E)C50 values are > 1 mg/L or above the water solubility limit (< 0.05 mg/L, purified water) for fish and algae. Therefore, 2,2-dimethyl-1,3-propanediyl dioctanoate does not meet the criteria for classification and labelling as acute aquatic hazard according to the 2nd ATP of the Regulation (EC) No. 1272/2008 (CLP).

Valid chronic toxicity data are available only for algae at present. The NOErC is above the water solubility limit. Therefore, 2,2-dimethyl-1,3-propanediyl dioctanoate does not meet the criteria for classification and labelling as long-term aquatic hazard according to the 2nd ATP of the Regulation (EC) No. 1272/2008 (CLP).

DSD:

The acute aquatic toxicity L(E)C50 values are > 100 mg/L or above the water solubility limit for fish and algae. Therefore, 2,2-dimethyl-1,3-propanediyl dioctanoate does not meet the criteria for classification and labelling as environmental hazard according to Directive 67/548/EEC.