reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.03 mg/L

PNEC freshwater (intermittent releases):

0.03 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.03 µg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

1 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

60.9 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.609 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

1 mg/kg soil dw

Assessment factor:

1 000

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

6.67 mg/kg food

Assessment factor:

300

Additional information

The environmental studies conducted on the substance have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. The majority of the information has been provided from a migrated NONS file referring to studies, which are more than 12 years old, with the permission of ECHA. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

General discussion

The acute toxicity study in both Fish and Daphnia produced no adverse results, with LC50 and NOEC values presented as limits at >1000 mg/L. Although no study details where provided as the data was provided by ECHA in a migrated NONS file, it is considered that these values are presumably based on Water Accomodated Fractions (WAFS). The algae study conducted yielded both an NOEC (72 h) and EC50 (72 h) of > 3 mg/L. As such, it should be noted that the substance did not demonstrate any toxic effects at the limit of solubility in water. A further study using the earthworm was also conducted; this also gave a NOEC of 1000 mg/l and EC50 > 1000 mg/l overall. This indicates that the substance does not produce environmentally hazardous effects to terrestrial organisms at well above the limit of solubility.

The values presented for PNEC are as derived using guidance document “R10 - Characterisation of dose [concentration] - response for environment”. However, as no effects were noted at the limit of solubility, a more accurate PNEC can be construed to be the soluble limit; i.e. 0.03 mg/L. Review of the guidance indicates that in section R.10.2.2.2 (Q)SAR and grouping approaches, QSAR can be used to provide additional supporting evidence of toxicity. Within the guidance, Table R.10-20 : Overview of programs for prediction of aquatic toxicity tools such as ECOSAR (U.S. EPA 1994) can be used to perform assessment. An assessment of the substance using this QSAR system indicated that no effects at saturation are predicted for these endpoints.

 

As the guidance for deriving the PNEC for does not provide assessment factors for substances with no effects at the limit of solubility, the assessment factors as proposed have been applied. 

The results given shows no toxic effect at saturation, the EC50 and LOEC values are higher than the solubility level of the test item in the test medium. No classification and labelling is applicable for acute aquatic effects. Classification is applied for chronic aquatic effects asAquatic Chronic 4 on the basis of the intrinsic properties noted for the substance.

Conclusion on classification

The results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute environmental effects is therefore required.

 

The CLP Regulation (EC No 1272/2008) states that Aquatic Chronic 4 is applicable to substances in:

 

Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 3), and which are not rapidly degradable and have an experimentally determined BCF≥500 (or, if absent, a log Kow≥4), indicating a potential to bioaccumulate, will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or evidence of rapid degradation in the environment.

The substance fulfills this criteria in that no scientific data apart from QSAR exists to dispute the bioaccumulation potential assigned to the substance. As such, the registrant accepts the current classification as listed in Annex VI to Regulation (EC) No 1272/2008; index reference 607-530-00-7 which is as follows:

CLP Regulation (EC No 1272/2008):Aquatic Chronic 4; H413: May cause long lasting harmful effects to aquatic life.

Dangerous Substance Directive (67/548/EEC):R53 May cause long-term adverse effects in the aquatic environment.

General discussion

The acute toxicity study in both Fish and Daphnia produced no adverse results, with LC50 and NOEC values presented as limits at >1000 mg/L. Although no study details where provided as the data was provided by ECHA in a migrated NONS file, it is considered that these values are presumably based on Water Accomodated Fractions (WAFS). The algae study conducted yielded both anNOEC (72 h) and EC50 (72 h) of > 3 mg/L. As such, it should be noted that the substance did not demonstrate any toxic effects at the limit of solubility in water. The values presented for PNEC are as derived using guidance document “R10 - Characterisation of dose [concentration] - response for environment”. However, as no effects were noted at the limit of solubility, a more accurate PNEC can be construed to be the soluble limit; i.e. 0.03 mg/L. Review of the guidance indicates that in sectionR.10.2.2.2 (Q)SAR and grouping approaches, QSAR can be used to provide additional supporting evidence of toxicity. Within the guidance, Table R.10-20 : Overview of programs for prediction of aquatic toxicitytools such as ECOSAR (U.S. EPA 1994) can be used to perform assessment. An assessment of the substance using this QSAR system indicated that no effects at saturation are predicted for these endpoints.

 

As the guidance for deriving the PNEC for does not provide assessment factors for substances with no effects at the limit of solubility, the assessment factors as proposed have been applied. 

The results given shows no toxic effect at saturation, the EC50 and LOEC values are higher than the solubility level of the test item in the test medium. No classification and labelling is applicable for acute aquatic effects. Classification is applied for chronic aquatic effects as Aquatic Chronic 4 on the basis of the intrinsic properties noted for the substance.