Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.34 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
13.4 µg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
273 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
3.62 µg/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:
9.7 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Brief description of classification related key information

Degradation

not readily biodegradable (OECD 301D)

Bioaccumulation

BCF (fish, Cyprinus carpio): 95-312 L/kg (experimental data)

Aquatic acute toxicity

For fish: 96 h, LC50 (O. latipes): 2.07 mg/L (OECD 203)

For algae/aquatic plant: 72 h, ErC50 (P. subcapitata): 0.134 mg/L (OECD 201)

For aquatic invertebrates: 48 h, EC50 (D. magna): 0.326 mg/L (OECD 202)

Aquatic chronic toxicity

For fish: 87d, NOErC (J. floridae): >= 0.83 mg/L (RL3)

For algae/aquatic plant: 72 h, NOErC (P. subcapitata): 0.0221 mg/L

For aquatic invertebrates: no data

 

Conclusion on classification

Classification justification according to CLP

Based on the data above, methylcyclohexane (CAS No. 108-87-2) is not considered to be rapidly degradable. The acute aquatic toxicity L(E)C50 is ≤ 1 mg/L for D. magna and P. subcapitata. Valid chronic toxicity data are available to P. subcapitata – the NOEC is 0.0221 mg/L.

Methylcyclohexane has been classified and labelled as environmental hazard, aquatic chronic 1 according to the Directive 67/548/EEC Annex1. However, due to the effect values as given above a self-classification of Acute Cat. 1 and Chronic Cat. 1 according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (5thATP) is proposed.

M-factor for acute aquatic toxicity:  1

M-factor for chronic aquatic toxicity: 1

 

Classification justification according to DSD

Based on the data above, methylcyclohexane is not considered to be rapidly degradable and to have low potential for accumulation. The acute aquatic toxicity L(E)C50 is (< 1 mg/L) for D. magna and P. subcapitata. One valid NOEC is available for P. subcapitata(NOEC = 0.0221 mg/L). Methylcyclohexane has been classified and labelled as environmental hazard, R51/R53 according to the Directive 67/548/EEC Annex1. However, due to the effect values as given above a self-classification of N, R50/53 according to Annex VI of Directive 67/548/EEC is proposed.