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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
110 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
182 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
11 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.53 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:
1 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The calculated PNEC aquatic for cyclohexanone oxime is 110 µg/L based on chronic data for algae and aquatic invertebrates. Fish was consistently less sensitive (one order of magnitude) in acute studies thus that chronic data for algae (most sensitive) and Daphnia are regarded to be sufficient for a safe aquatic hazard assessment. Cyclohexanone oxime was shown to be readily biodegradable fulfilling the 10-day window-requirement. It does not show surface active properties and the octanol-water partition coefficient is very low. Relevant distribution to sludge, sediment or soil therefore is highly unlikely. This is corroborated by the 3-h value from a test on inherent biodegradability (Zahn-Wellens test, RL 2) used as an adsorption control: Adsorption was found to be negligible (2.7%). From this same test a NOEC for microorganisms of sewage treatment plants could be derived, being the basis for PNECSTP derivation (PNECSTP: 65.6 mg/L). This is corroborated by a supporting study on activated sludge respiration inhibition.

Conclusion on classification

1     Classification according to Regulation (EC) 2008/1272 (CLP)

Classification according Regulation (EC) 2008/1272 (CLP) is performed independently for acute and chronic hazards. If data for chronic hazards are incomplete (data not available for all three trophic levels), chronic classification is performed both, based on acute data and based on available chronic data and the more stringent outcome is taken for final chronic classification.

Acute hazard category:

The lowest acute aquatic toxicity of three trophic levels was determined for algae (Desmodesmus subspicatus) with an acute EC50 (72 h, growth rate) of 18.24 mg/L.

Thus, no acute classification results from the available acute aquatic ecotoxicity data.

Chronic hazard category:

Using available acute data, decisive for a possible chronic classification is failure or fulfillment of (1) rapid degradability and / or (2) presence or absence of a bioaccumulation potential.

As substitute for an experimentally determined BCF in fish log KOW is taken as an indicator of bioaccumulation potential. As log KOW of the submission substance is clearly below the cut-off value according to CLP of 4.0, the submission substance is regarded as non-bioaccumulative.

Rapid biodegradability according to CLP is given for substances which were assessed as “readily biodegradable” in screening studies (OECD 301) with a minimum of 60% O2-depletion or CO2 -evolution of theoretical maximum within 28 days and at the same time fulfillment of the 10-day-window. This is met by the submission substance. The submission substance is therefore considered as rapidly biodegradable.

No chronic classification results for the submission substance from the available acute data on ecotoxicity, the degradation and bioaccumulation potentials.

 

Using available chronic data for algae (most sensitive) and invertebrates, from the algae EC10 (96 h, growth rate) of 1.1 mg/L a chronic classification for rapidly degradable substances results. Thus, the final chronic classification according to regulation (EC) 2008/1272 (CLP) is the following:

Category Chronic 3, H 412: Harmful to aquatic life with long lasting effects, no M-factor

2     Classification according Directive 67/548/EEC (DSD)

The lowest acute aquatic toxicity of three trophic levels was determined for algae (Desmodesmus subspicatus) with an acute EC50 (72 h, growth rate) of 18.24 mg/L. The submission substance is considered as rapidly biodegradable and without potential for bioaccumulation (log Kow < 3.0).

Thus, no classification according to Directive 67/548/EEC (DSD) is resulting.