2-hydroxymethyl-9-methyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decane

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

24 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

240 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

2.4 µg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

11.4 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.16 mg/kg sediment dw

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.016 mg/kg sediment dw

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

0.018 mg/kg soil dw

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

6.67 mg/kg food

Assessment factor:

300

Additional information

Details on the calculation of the PNECs for sediment and soil:

PNEC sediment - fresh water:

PNEC sediment = (Ksusp-water/RHOsediment)*PNECwater*1000

with:

* Ksusp-water = 1.655 (calculated in EUSES on basis of log Koc of 1.48)

* RHOsusp = 1150 kg/m3 (bulk density of suspended matter)

* PNECwater = 0.024 mg/L

PNEC sediment - marine water:

PNEC sed = (Ksusp-water/RHOsediment)*PNECsaltwater*1000

with:

* Ksusp-water = 1.655 (calculated in EUSES on basis of log Koc of 1.48)

* RHOsusp = 1150 kg/m3 (bulk density of suspended matter)

* PNECmarine water = 0.0024 mg/L

PNEC soil:

PNEC soil = (Ksoil-water/RHOsoil)*PNECwater*1000

with:

* Ksoil-water = 1.1 (calculated in EUSES based on log Koc of 1.48)

* RHOsoil = 1700 kg/m3 (bulk density of wet soil)

* PNECwater = 0.024 mg/L

PNEC oral:

PNEC oral = NOEC / AF

and

NOEC = NOAEL * CONV

with:

* NOAEL = 200 mg/kg bw*d (based on no mortality observed in 28d repeated dose study)

* CONV = 10 for rats <= 6 weeks

* AF = 300

Conclusion on classification

The following aquatic toxicity data are available for 3 trophic levels (fish, daphnia, algae):

* fish: 96h LC50: 24 mg/L

* daphnia: 48h EC50: 62 mg/L

* algae: 72h ErC50: 80 mg/L (acute)

* algae: 72h ErC10: 31.4 mg/L (chronic)

The following environmental fate data are available:

* Log Kow = 3.04

* Not rapidly biodegradable

CLP classification

Acute aquatic hazard

The lowest acute aquatic toxicity value is > 1 mg/L (lowest value is 24 mg/L for fish). Substance is not to be classified for acute aquatic toxicity and consequently, determination of an M-factor is not applicable.

Chronic aquatic hazard:

There is only adequate chronic toxicity information available on algae. Consequently, the classification is to be determined via two different approaches. The first one being based on the available chronic information in combination with the degradation potential of the substance (Table 4.1.0(b)(i)) and the second one based on acute aquatic toxicity information in combination with the degradation and bioaccumulation potential (Table 4.1.0(b)(iii)).

 

·  Based on the available chronic information (Table 4.1.0(b)(i)): The lowest EC10 value is > 1 mg/L, hence no classification is warranted based on this approach.

·  Based on the surrogate acute classification scheme (Table 4.1.0(b)(iii)): The lowest acute toxicity value is between 10 a and 100 mg/L (fish) and the substance is not rapidly biodegradable. Consequently, Category Chronic 3 (H412) is applicable.

·  Based on the available information, no M-factor is required.

 

Conclusion: Based on the most stringent classification, the substance is to be classified as Category Chronic 3 (H412).

DSD classification

According to the criteria described in section 5.2.1.2 of Annex VI to Directive 67/548/EEC (Dangerous Substances Directive), a substance shall be classified as R52/53 in case the LC50 values determined in acute toxicity tests are in the range of 10-100 mg/L, and the substance is not readily biodegradable. As a consequence, classification with R52/53 under DSD is required in the current case.