Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral

Additional information

Due to the low water solubility the studies were carried out with Water Accomodated Fractions (WAF). These results are presented as loading rates in water. As these are all 'greater then' values, they cannot be used for the derivation of a PNEC. The results of the key studies are summarised in the table.

Where test concentrations were measured they were below 1 mg/l. Results were expressed based on the loading rates.

Guideline 

Test species 

endpoint 

result, mg/l loading rate

(Measured)

remarks 

OECD 203

Cyprinus carpio

96h-LC50

> 100

(Meas: 0.7 - 0.075)

Key study

GLP, rel.1

OECD 203

Brachydanio rerio

96h-LC50

(Meas. )1216.1 mg/l **

Supporting study

GLP, rel 1

OECD 202

Daphnia magna

48h-EC50

> 100

(M:>0.0271 )

Key study

OECD 201

Pseudokirchneriella subcapitata 

*72h- NOEC growth

*72h-EC50 growth

> 32

> 100

(Meas. < 0.001)

Key study

GLP,rel.1

OECD 201

Scenedesmus subspicatus = Desmodesmus subspicatus

72h-EC10

72h-EC50

> 100

> 100

Not measured

Supporting study

GLP,rel. 1

OECD 209

Activated sludge (domestic)

30 min-NOEC

> 1000

Not measured

Key study

no GLP, rel. 1

*24h-Pre-exposure period in the dark in view of photodegradability of the test substance. Test conc after 96 h (is after 72 h of light) < 0.001 mg/l

** This measured concentration is far above the water solubility limit

Due to the low water solubility, a PNEC cannot be derived in this way. Therefore it was checked whether the Predicted Environmental Concentration PEC is < water solubility (ranging from 0.22 - 0.75 mg/l).

In IUCLID section 5 it was concluded that

1. Environmental prediced concentrations in a conservative model for release from sunscreen agents predicted concentrations in water of 0.0015 mg/l. Two other model predicted values of 0.00025 to 0.004 mg/l and 0.000002 to 0.00007 mg/l. These ranges are below 1/100 of the water solubility range of the test substance (0.22 - 0.75 mg/l).

2. Observed concentrations in water related to the above predictions were < 1 - 28 nanogram/l and in sediment 0.015 mg/kg ds. This is lower than the observations by three orders of magnitude.

According to the guidance document on Data requirements and CSR R. 7 and R.10, it is concluded that for a poorly soluble, highly lipophilic substance where no toxicity is observed in short term studies, a long term study may be needed if the PEC is above 1/100 of the water solubility limit. The test substance is biodegradable and photodegradable. It was shown in section 5 that the predicted and the actually measured environmental concentrations are below 1/100 of the water solubility limit. Therefore the risks are expected to be of no concern and no further studies on the ecotoxicity of the test substance are needed.

Conclusion on classification

The short term toxicity studies for algae, daphnia and fish resulted in no aquatic toxicity within the limit of water solubility. Since the substance is readily and ultimately (anaerobic) biodegradable no classification for toxicity is needed, thus the substance is not classified.