Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.008 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Alchisor TAL 111 is decene, hydroformylation products, low boiling and can be characterised as a UVCB substance. As defined in the ‘Read-Across Justification Document’ section 13, data provided for the analogue substance Alchisor TAL 123 and the Alchisor TAL 111 consitutent category substances, Category 3 hydrocarbon solvents, are representative of Alchisor TAL 111 and suitable for assessment purposes. Study data for each analogue/constituent category has been evaluated and considered together. The most relevant and reliable NOELR study result from across the analogue/constituent categories has been identified and used to derive the PNECs.

The PNECfreshwater for Alchisor TAL 111 is 0.0079 mg/L, which is based onthe most sensitive NOELR for fish (Redman, 2010) of 0.079 mg/L and an AF of 10. The basis of the PNECmarine is the same study by Redman (2010) with an AF of 100 (PNEC is 0.00079 mg/L). There is a paucity of toxicity data for sediment and soil organisms across the analogue/constituent categories of Alchisor TAL 111 substances, and the derivation of PNEC sediment and soil are waived on the basis of no potential for exposure to organisms in these environmental compartments due to the ready biodegradability of Alchisor TAL and its constituents. Experimental evidence for mammals indicates that Alchisor TAL 111 and its constituents are unlikely to present a hazard to birds and a PNECoral is waived.

Conclusion on classification

Alchisor TAL 111 is an alkenes C10 -C11, hydroformylation product, low boiling and can be characterised as a UVCB substance. As defined in the ‘Read-Across Justification Document’ section 13, data provided for the analogue substance Alchisor TAL 123 and the Alchisor TAL 111 consitutent category substances, Category 3 hydrocarbon solvents, are representative of Alchisor TAL 111 and suitable for assessment purposes. Study data for each analogue/constituent category has been evaluated and considered together. The most relevant and reliable toxicity study results from across the analogue/constituent categories have been identified and used for environmental classification of the complete product.

All analogue and constituent category substances of Alchisor TAL 111 are readily biodegradable and, although the log Pow is 3 it is argued in the read-across justification report (ENVIRON, 2012) that none of the constituents have BCFs that exceed 100 due to rapid biotransformation in biota (fish). Additionally, due to rapid biodegradation and adsorption to organic, dissolved and particulate materials all of the constituent categories exhibit reduced availability for aquatic life. As such, the Alchisor TAL 111 product, and its constituent categories, do not quality for classification under DSD classification.

Under the GHS system, the complete TAL 111 product is classified as Chronic Category 2 based on the calculated toxicity of consituent categories. The constituent categories are rapidly biodegraded and adequate chronic toxicity data are available. In summary, in compliance with classification and labelling regulations, Alchisor TAL 111 is not classified for the environment under DSD and H411 toxic to aquatic life with long lasting effects under GHS.

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