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:
42 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNECaqua

Three reliable short-term toxicity studies are available, i.e. for algae, daphnia and fish (acc. to OECD 201, 202 and 203). Observed effects in daphnia and algae were related to increased pH, which was produced due to the alkaline characteristic of the submission substance. No adverse effects were observed with regard to the inherent toxicity of the submission substance, which was shown by pH adjusted treatment groups at limit test concentrations. Therefore, no hazard was identified.

PNECstp

An acceptable toxicity study on STP microorganisms is available for the submission substance (acc. to OECD 209). The derived no effect concentrations was: 3h-NOEC (activated sludge, total respiration inhibition) = 420 mg a.i./L. It must be noted that observed effect are likely related to pH rather than the inherent toxicity of the test substance. According to ECHA guidance R.10, a NOEC derived from OECD 209 can be used as the basis for the PNECstp derivation by applying an assessment factor of 10. The resulting PNECstp is therefore 42 mg a.i./L for the submission substance.

PNECsoil and PNECsediment

See justification for PNECaqua: no hazard was identified.

Secondary poisoning

There is no potential for bioaccumulation of the submission substance, because of the low octanol-water partitioning coefficient of the submission substance, i.e. log Pow < 3. No hazard for predators such as secondary poisoning is expected.

Conclusion on classification

Classification according to Regulation (EC) No 2008/1272 (CLP)

Acute hazard category

There are adequate short-term studies available covering three trophic levels, i.e. algae, daphnia and fish. No hazard was identified. According to the classification criteria laid down in Regulation No (EC) 2008/1272, the submission substance does not need to be classified.

 

Chronic hazard category

There are no adequate chronic toxicity data available, except for a long-term NOEC for aquatic algae. No hazard was identified in the available long-term and short-term studies. According to the classification criteria laid down in Regulation No (EC) 2008/1272, the submission substance does not need to be classified.

 

In conclusion, the submission substance is not classified for the environment according to Regulation No (EC) 2008/1272