Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
10 000
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:
0.036 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.004 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:
0.02 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

After re-examination of the substance description and based on the ECHA Guidance for identification and naming of substances under REACH, the lead registrant agreed with the other SIEF members that the identifiers (CAS number and EC name) used for the toxicological, ecotoxicological and physico-chemical testing are not representative of the UVCB substance used for the testing. Consequently, the EC name Bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate and CAS number 5493-45-8, mentioned in the testing reports and refering to a monoconstituent substance are incorrect and should be read as 1,3-Isobenzofurandione, hexahydro-, reaction products with epichlorohydrin with CAS number 1395383-69-3, which is representative of the registered UVCB substance used effectively.

Conclusion on classification

According to the Guidance on the Application of the CLP Criteria , if the acute aquatic toxicity is >10and ≤100 mg/L, (96h LC50 (fish) = 17 mg/L, 48h EC50 (daphnia) = 71.6 mg/L, and 72h ErL50 (algae) > 56 mg/L), and as the substance is not considered to be rapidly degradable with low a potential for bioaccumulation (log Kow = 1.7), the substance should be classified Aquatic Chronic Category 3 (H412: Harmful to aquatic life with long lasting effects) according to Regulation (EC) No 1272/2008, Annex I section 4.1.