Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.32 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.51 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.032 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
11.5 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.15 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.34 mg/kg soil dw
Assessment factor:
50

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
11.6 mg/kg food
Assessment factor:
90

Additional information

PNECaquatic: Fish were marginally more susceptible to TCPP in the acute tests than the invertebrate, Daphnia magna, and the two species of algae. Given the similarity in acute susceptibility of the three taxa, further testing to determine a threshold concentration for chronic effects in fish could not be justified on animal welfare grounds. A NOEC of 32 mg/l and an ErC10 value of 42 mg/l (NOEC 13 mg/l) were determined respectively in the chronic test with Daphnia magna and in the growth inhibition test with the alga Pseudokirchneriella subcapitata. A PNECaquatic of 0.32 mg/l has been derived from the Daphnia test data by dividing the NOEC of 32 mg/l for effects on Daphnia magna reproduction by an assessment factor of 100. Following the discussion in the European Union Risk Assessment Report of tris(2 -chloro-1 -methylethyl) phosphate, this value is the PNECaquatic considered as the most appropriate value. In the Risk Assessment Report, an alternative PNEC is derived from the algal NOEC, for the purposes of comparison. This is in accordance with guidance received from TC NES I 05, because the basic guidance from the TGD and the Guidance document on information requirements and chemical safety assessment, Chapter R.10 is not entirely clear as to whether the EC10 or NOEC from the algal study should be used as the main result, in the context of PNEC derivation. In this case, due to the shallow dose-response relationship seen in the study with P. subcapitata, it is considered appropriate to use ErC10 as the primary result of the study. The Daphnia result is more sensitive than the algal ErC10. An alternative PNECaquatic of 0.13 mg/l can be derived from the algal test data by dividing the NOEC of 13 mg/l for effects on P. subcapitata by an assessment factor of 100.

Conclusion on classification

Presently there are only two long-term aquatic toxicity studies, conducted on freshwater invertebrates (OECD 211) and an algal growth inhibition test (OECD 201).  In accordance with the CLP Regulation and Guidance on its application, when only two long-term aquatic studies are available, the registration must apply both classification approaches for chronic hazards (based on short -erm data and long-term data), and then classify according to the most stringent outcome (ECHA Guidance on the Application of the CLP Criteria.  Version 5.0.  July 2017).


Classification based on Long-term Data:


OECD 201: 72h ErC10 = 42 mg/L
OECD 211: 21d NOEC = 32 mg/L
Rapidly Degradable: No


Based on the available data, the substance is not classified for the environment in accordance with the CLP criteria for long-term aquatic hazard for non-rapidly degradable substances for which there are adequate chronic toxicity data available


Classification based on Short-term Data:


OECD 201: 72h ErC50 = 82 mg/L
OECD 202: 48h EC50 = 131 mg/L
OECD 203: 96h LC50 = 51 mg/L
Rapidly Degradable: No
BCF ≥ 500: No


Based on the available data, the substance should be classified as Aquatic Chronic 3 (H412: Harmful to aquatic life with long lasting effects), in accordance with the CLP criteria for long-term aquatic hazard for substances which adequate chronic toxicity data are not available.