Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.51 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.11 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.051 mg/L
Assessment factor:
100
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:
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:
insufficient hazard data available (further information necessary)

Additional information

Several reliable aquatic toxicity studies in fish, invertebrates, and algae have been conducted using DMDMH or the hydrolysis product of DMDMH (DMH) and are included in this dossier. DMDMH readily undergoes hydrolysis to DMH and therefore data is provided for both substances where available. In the case of long-term testing, the data on DMH is considered more relevant for environmental fate and ecotoxicology and are considered in this dossier. There was a paucity of toxicity of data for sediment and soil organisms, but the substance is not likely to be applied directly or indirectly to these compartments and is readily biodegradable and is low in toxicity to aquatic organisms, the PNECs for soils and sediments are waived.  There were no reliable toxicity data for aquatic plants; however, a waiver is being applied for this endpoint. It can be concluded that short-term toxicity testing of terrestrial organisms is not required based on the unlikely exposure of soil organisms to the DMDMH product or its degradation product (DMH).

Conclusion on classification

DMDMH, or the hydrolysis product, DMH, do not fulfil the screening criteria for persistence (P-criterion), bioaccumulation (B-criterion), or toxicity (T-criterion). Therefore, no further testing or emission characterization and risk characterization for PBT/vPvB substances in accordance with REACH Article 14(4) is required.