Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2.44 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
7.7 µg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.123 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:
5.33 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
40.33 mg/kg food
Assessment factor:
90

Additional information

The PNECs for the aquatic environment are derived from the lowest effect level observed in the available long-term aquatic toxicity tests (EC10 Daphnia Reproduction study 0.122 mg/L) and via application of the appropriate assessment factor (50) to.


PNECSTP can be calculated via biodegradation endpoints using the concentration where no toxicity to microorganisms was observed, which can be considered the NOEC. In this case, no toxicity was observed at the test concentration of 100mg/L. An assessment factor of 10 should be used when evaluation PNECSTP in this way. Therefore PNECSTP = 10 mg/L.


 


The PNEC secondary poisoning was derived from the available information on 90-day repeat dose toxicity NOAEL of 360mg/kg bw/day by multiplying by a conversion factor of 20 (rattus norvegicus > 6 weeks) to derive a NOEC, and then dividing by assessment factor of  90 (sub-chronic study) in accordance with ECHA guidance R.10.8.


 


For sediment PNECs, wet weight PNECs were calculated using the equilibrium partitioning method as described in Guidance R.10 & R.16, conversion to dry weight was performed with factor of 4.6.


 


The PNECsoil was derived from soil toxicity data. The observed LC50 from the acute earthworm test (OECD 207) was 127.8 mg/kg soil dw. Chronic or long-term toxicity testing on soil microorganisms (OECD 216) and terrestrial plants (OECD 208 with six species, two monocotyledonous and four dicoyledonous) gave respectively a NOEC of ≥500 mg/kg soil dw and EC10 of 89.3 mg/kg soil dw (tomato, most sensitive species). Both long-term terrestrial toxicity studies were performed in a Speyer 2.3 soil with soil Organic Carbon content of 0.67%. The standard assumption for soil Organic Carbon content is a default of 2 %. The PNEC for terrestrial organisms has, therefore, been normalised to take in to account the soil Organic Carbon content and assessment factor of 50.  According to ECHA guidance (Chapter R.7c, section R.7.11.5.3) where data from chronic or long-term tests are available, they should be used in preference to short-term tests to derive the PNEC. Since two long-term NOECs/EC10s are available, the PNEC has been derived from the lowest long-term result of the two trophic levels using, in accordance with ECHA Table R.10 -10, an assessment factor of 50 to give a PNECsoil of 5.33 mg/kg soil dw.

Conclusion on classification

Environmental classification and labelling of a substance is generally based on data from short-term aquatic toxicity results, the ready biodegradability of the substance and an experimentally determined BCF (or if absent the measured octanol/water partition coefficient). Available adequate chronic toxicity data is also relevant for the assessment of long-term aquatic hazards (Regulation 286/2011/EC).


Short-term aquatic toxicity data is available for all three trophic levels. The lowest short-term L(E)C50 was for algae with a 72-hour EC50 value of 0.77 mg/l based on growth rate.  The 48 hour EC50 for Daphnia is 0.88 mg/L and the 96 hour LC50 for fish 1.34 mg/L. 


Chronic aquatic toxicity data is available for  both algae and Daphnia: the 72-hour NOEC is 0.2 mg/L (based on growth rate) for algae, and the 21 day EC10 for Daphnia is 0.122 mg/L.


Amyl salicylate is readily biodegradable, has a BCF of 380 -570 L/kg (based on an experimentally determined BCF for the analogue substance, cyclohexyl salicylate, and supported by QSAR) and a log Kow of 4.4 to 4.5.


Based on the above data, amyl salicylate is classified as R50/53 according to Directive 67/548/EEC (DSD) and Aquatic Acute 1 (H400) & Chronic 2 (H411) according to Regulation 1272/2008/EC & adaptation 286/2011/EC (CLP). According to Regulation (EC) No. 286/2011, Table 4.1.3, in order to classify a mixture containing the substance an M-factor of 1 should be used when applying the summation method.