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:
no hazard identified

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:
PNEC soil
PNEC value:
7.56 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

The results from the acute aquatic toxicity studies are as follows:

LC50 (96 h) fish = 12.7 mg/l (measured concentration) with 95% confidence limits of 8 -16 mg/l.

EC50 (48 h) Daphnia = 22.1 mg/l (measured concentration) with 95% confidence limits of 18.4 - 24.3 mg/l.

ErC50 (72 h) algae was determined to be greater than the solubility limit of the substance (32.36 mg/l, measured concentration).

EC50 microorganisms was determined to be greater than 1000 mg/l.

Based on these results, the lowest acute E(L)C50 is higher than 1 mg/L. Therefore, the registered substance is not classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.

In addition, adequate chronic toxicity data available for fish, crustacea and algae:

NOEC (28d) fish = 1.4 mg/l (measured concentration)

NOEC (7d) C. dubia = 3.64 mg/l (measured concentration)

ErC10 (72 h) algae = 23.12 mg/l (measured concentration) with 95% confidence limits of 15.23 – 33.44 mg/L.

CLP Classification proposal:

It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation:

- Acute aquatic hazard: not classified. Reasoning: lowest E(L)C50 greater than 1 mg/L.

- Chronic aquatic hazard: not classified. Reasoning: Non-rapidly degradable substance for which there are adequate chronic toxicity data available, lowest chronic NOEC or EC10 value greater than 1 mg/L.

Conclusion on classification:

- according to Directive 67/548/EEC the substance RDX is not classified hazardous to the aquatic environment.

- according to the CLP Regulation 1272/2008 the substance RDX is not classified hazardous to the aquatic environment.