Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.018 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.018 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
100
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:
2 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.2 mg/kg sediment dw
Assessment factor:
500
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
10 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

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

Additional information

To fulfill all requirements for the ecotoxicological information of Benzenepropanoic acid, 3,5 -bis(1,1 -dimethylethyl)-4 -hydroxy-, C7-9 branched alkyl esters (CAS 125643-61-0), the following read-across substances were considered: Butyl 3.5 -bis(1,1 -dimethylethyl)-4 -hydroxybenzenepropanoate (CAS 52449-44-2) and Benzenepropanoic acid, 3,5 -bis(1,1 -dimethylethyl)-4 -hydroxy-2 -ethylhexylester (CAS 144429 -84 -5). For justification of this read-across procedure, please refer to the read-across statement of the test substance.

Since all data are used, also the same classification and labeling has to be applied to Benzenepropanoic acid, 3,5 -bis(1,1 -dimethylethyl)-4 -hydroxy-, C7 -9 branched alkyl esters (CAS 125643-61-0).

The most critical effects were given by the short-term tests for fish (LC50(96h) > 0.0011 mg/L, Goodband and Mullee, 2009) and for daphnids with an EC50(48h) > 0.224 mg/L (Mead and Mullee, 2007). The assumed high toxicity potential can be refuted by the fact that the substances are of low water solubility, which is also remarked in the study reports. Furthermore, at least for daphnids the long-term NOEC (NOEC(21d) of 3.2 mg/L) may refute a stringent classification of the test substance.

On the other hand, neither the target nor the read-across substances were found to be readily biodegradable and a bioaccumulation potential in aquatic biota can not be completely ruled out (Mino, 2002).

Based on the available data and for environmental safety aspects, the substance shall be classified as "aquatic chronic 4" (Classification due to likely environmental risks - "Safety net") with Hazard Statement H413 (May cause long lasting harmful effects to aquatic life) and Precautionary Statements P273 (Avoid release to the environment) and P501 (Dispose contents/container in accordance with local/regional/national/international regulations). For labelling, no hazard pictogram and no signal word has to be used.

This classification is in accordance to Annex VI (Table 3.1) of Regulation (EC) 1278/2008 of the European Parliament and of the Council.

Conclusion on classification

In accordance to Annex VI (Table 3.1) of Regulation (EC) No. 1278/2008 of the European Parliament and of the Council, the substance has to be classified as "aquatic chronic 4" with Hazard Statement H413 (May cause long lasting harmful effects to aquatic life) and Precautionary Statements P273 (Avoid release to the environment) and P501 (Dispose contents/container in accordance with local/regional/national/international regulations). No pictogram and no signal word has to be applied.