Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.04 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.4 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.004 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.032 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:
0.028 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNECoral for the evaluation of secondary poisoning was not calculated, based on the waiver described by ECHA (Section B.7.2.7 of Part B, Hazard assessment, of Guidance on information requirements and chemical safety assessment, May 2008, pp. 45-47) and the assessment whether the exposure route of secondary poisoning is relevant (Section R.16.5.7.2, Chapter 16 “Environmental Exposure Estimation”, of Guidance on information requirements and chemical safety assessment, May 2008, pp. 93-94).

Conclusion on classification

S-104 and other related acetylenic diols have a low potential to cause toxic effects if accumulated in higher organisms, as described by ECHA (Section R.16.5.7.2, Chapter 16 “Environmental Exposure Estimation”, of Guidance on information requirements and chemical safety assessment, May 2008, pp. 93-94). These criteria include the classifications Very Toxic (T+), Toxic (T), harmful (Xn), and the risk phrases R48 (“danger of serious damage to health by prolonged exposure”), R60 (“may impair fertility”), R61 (“may cause harm to the unborn child”), R62 (“possible risk of impaired fertility”), R63 (“possible risk of harm to the unborn child”) or R64 (“may cause harm to breastfed babies”).

Therefore, S-104 meets the criteria for waiving the PNECoral, (based on log Kow values < 3, low toxicity to mammals, non-bioaccumulative and inherently biodegradable). Therefore, the secondary poisoning pathway is not relevant and a value for PNECoral was not derived.