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:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
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

The PNECs will be revised and updated after completion of all requested ecotoxicological studies by ECHA.

Due to the low water solubility the studies were carried out with Water Accommodated Fractions (WAF). Where test concentrations of the test item 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

Danio rerio

96h-LC50

(Meas.) 1216.1 mg/L
**

Supporting study
GLP, rel. 1

OECD 234

Danio rerio

63d-NOEC

63d-LOEC

<46.9 µg/L (Meas.)

46.9 µg/L (Meas.)

Key study

GLP, rel. 1

OECD 210 (mmodified)

Danio rerio

21d-NOEC

≥30 µg/L (Meas.)

Supporting study

non-GLP, rel.1

OECD 202

Daphnia magna

48h-EC 50

> 100 mg/L
(Meas: >0.0271 mg/L)

Key study

GLP, rel. 1

OECD 201

Pseudokirchneriella
subcapitata

*72h- NOEC growth
*72h-EC50 growth

> 32 mg/L

> 100 mg/L
(Meas. < 0.001)

Key study
GLP, rel.1

OECD 201

Scenedesmus subspicatus
= Desmodesmus
subspicatus

72h-EC10
72h-EC50

> 100 mg/L

> 100 mg/L
Not measured

Supporting study
GLP, rel. 1

OECD 209

Activated sludge (domestic)

30 min-NOEC

> 1000 mg/L
Not measured

Key study

no GLP, rel. 1

OECD 231

Xenopus laevis

21d-NOEC

≥44.2 µg/L (Meas.)

Key study

GLP, rel. 1

* 24-h 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 predicted 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.

Conclusion on classification

The short-term toxicity studies for algae, daphnia and fish resulted in no short-term (acute) aquatic toxicity within the limit of water solubility.

In a long-term toxicity study with fish according to OECD 210 a NOEC >30 µg/L test substance (measured) was derived. In an OECD 234 study, a NOEC <46.9 µg/L and a LOEC = 46.9 µg/L based on mean measured concentrations were determined based on toxicity effects on the liver. Since the substance is readily and ultimately (anaerobic) biodegradable, the substance is clsssified as long-term (chronic) toxicity Category 2, H411 according to the classification criteria of the CLP Regulation 1272/2008 EC.