Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
7.4 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.74 mg/kg sediment dw
Assessment factor:
1 000
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:
0.1 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

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

Additional information

An acute fish toxicity test was conducted with the test substance, triisodecyl benzene-1,2,4-tricarboxylate according to EEC-Guideline L251 Vol. 27, 84/449/EEC: C (static procedure). No mortalities occurred. The 96 hour LC50 for the substance was > 1000 mg/L. Toxicity to fish of read-across substance, tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate, has been investigated in 14 day test according to OECD test methods. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The 14 day NOEC was determined to be >75.0 mg/L. It is recognised that the duration of the OECD TG 204 test is shorter than that currently accepted for investigating long-term toxicity in fish. Waiving of additional testing is proposed based both on the lack of effects seen in the 14-day fish study and chronic Daphnia reproduction study.

Acute immobilisation in Daphnia has been investigated with read-across substance, tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate, in a 48 hour test conducted according to OECD test methods. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The EC50 (48h) was determined to be >180 mg/L and the NOEC was 180 mg/L, the highest concentration investigated. In an acute Daphnia toxicity study conducted with the test substance, triisodecyl benzene-1,2,4- tricarboxylate, the 24 h EC50 value was 1.5 mg/L, however, there was test substance floating on surface of water at 5.8 mg/L (nominal) after 24 h exposure, which may have affected mobility of Daphnia, therefore the results of this study are not considered to be reliable.

Chronic toxicity to Daphnia has been investigated in a 21 -day reproduction test according to OECD test methods with read-across substance, tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The following values were calculated: NOEC (21 -day, reproduction): 55.6 mg/L; LOEC (21 -day, reproduction): >100 mg/L; EC50 (21 -day, reproduction): 89.1 mg/L.

The effect of read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, on algae growth has been investigated in a 72 hour test according to OECD test methods. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The EC50 (72h) was determined to be >100 mg/L and the NOEC was 100 mg/L, the highest concentration examined.

The read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, is not toxic at concentrations up to 1000 mg/L to activated sludge of a municipal sewage treatment plant.

Conclusion on classification

The environmental studies conducted on the substance and on the read-across substance, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, have all been ranked reliability 1 or 2 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for environmental effects is therefore required.

The substance is therefore proposed to be “not classified” and appropriate comments are detailed within Section 2 of the registration dossier.

 

The substance is therefore proposed to be “not classified” and appropriate comments are detailed within Section 2 of the registration dossier.