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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
26 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
32 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
2.6 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
5 500 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
10 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:
4.8 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The derivation of the Predicted No Effect Concentrations was performed according to the ECHA R.10 guidance on Characterisation of dose [concentration]-response for environment (2008). In agreement with this guidance (p 11) EC10 for a long-term tests, as obtained using an appropriate statistical method (i.e. regression analysis) was be used preferentially over the NOEC (see conclusion on classification below).

As discussed in the chapter on Aquatic toxicity, all short-term toxicity results, available for the three trophic levels, indicated L(E)C50 levels above 1 mg/L, with the lowest level for the fish. Due to the experimentally shown rapid and ready biodegradability and the low lipophilicity (Log Kow 0.9), long-term toxicity could be assessed on the basis of short-term toxicity data, but long-term experimental results are available. These long-term toxicity results indicated effects at a level below the lowest acute toxicity, i.e. the NOEC from the fish embryo test of 1.5 mg/L. The point of departure for the chronic toxicity is thus the EC10 on daphnid reproduction of 1.3 mg/L.

  • ECB European Chemicals Bureau (2003) Technical Guidance Document in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances, Commission Regulation (EC) No 1488/94 on Risk Assessment for existing substances and Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Parts I to IV. Self-published.
  • ECHA R.10: European Chemicals Agency (2008). Guidance on information requirements and chemical safety assessment. Chapter R.10: Characterisation of dose [concentration]-response for environment. Guidance for the implementation of REACH. Self-published, Helsinki, Finland, in May. 238 p.
  • EMEA European Medicines Agency (2007) Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 AND GL 38 - EMEA/CVMP/ERA/418282/2005-corr, 63 p.

Conclusion on classification

The following statements base on DSD, the Commission Directive 2001/59/EC (28th ATP of Council Directive 67/548/EEC) and CLP (5th ATP of Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU:

Harmonized Classification

The submission item is not legally (harmonized) classified in accordance with DSD and GHS/CLP regulations and lacks in Tables 3.1 and 3.2.

Environmental hazards

The classification was done in agreement with ECHA (2013) guidance on CLP using the 2nd ATP to CLP published in the Official Journal of the European Union of 30 March 2011, p L 83/1 to L 83/53, as Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, where the applicable Table 4.1.0 “Classification categories for hazardous to the aquatic environment” (L 83/21) and chapter 5.1.2.1. were last updated.

A) Acute (short-term) aquatic hazard

The sole implemented Category 1 classification is according to Table 4.1.0 (a) required if:

96 hr LC50 (for fish) ≤ 1 mg/L and/or

48 hr EC50 (for crustacea) ≤ 1 mg/L and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/L.

All short-term L(E)C50 of the submission item were found > 1 mg/L.

In conclusion no classification for acute (short-term) aquatic hazard is required.

B) Long-term aquatic hazard

The Rapid Biodegradability condition applies. As discussed in the section on “biodegradation in water: screening tests” the submission item is rapidly and readily biodegradable. Therefore classification according to Table 4.1.0 (b), (i) or (iii) is excluded. In consequence Table 4.1.0 (b), (ii) for “Rapidly degradable substances for which there are adequate chronic toxicity data available” applies and any assignment of a higher chronic category based on acute toxicity data > 1 to ≤ 10 mg/L or > 10 to ≤ 100 mg/L (which were found for the submission item) as given in Table 4.1.0 (b), (iii), cannot apply.

The implemented Categories 1 to 4 are according to Table 4.1.0 (b), (ii) and “Safety net” required if:

Category Chronic 1:

Chronic NOEC or ECx (for fish) ≤ 0.01 mg/L and/or

Chronic NOEC or ECx (for crustacea) ≤ 0.01 mg/L and/or

Chronic NOEC or ECx (for algae or other aquatic plants) ≤ 0.01 mg/L.

Category Chronic 2:

Chronic NOEC or ECx (for fish) > 0.01 to ≤ 0,1 mg/L and/or

Chronic NOEC or ECx (for crustacea) > 0.01 to ≤ 0,1 mg/L and/or

Chronic NOEC or ECx (for algae or other aquatic plants) > 0.01 to ≤ 0.1 mg/L.

Category Chronic 3:

Chronic NOEC or ECx (for fish) > 0.1 to ≤ 1 mg/L and/or

Chronic NOEC or ECx (for crustacea) > 0.1 to ≤ 1 mg/L and/or

Chronic NOEC or ECx (for algae or other aquatic plants) > 0.1 to ≤ 1 mg/L.

Category Chronic 4:

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 4), and which are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, which 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 other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in section 4.1.2.9.5.

According to ECHA (2013) guidance, chapter 4.1.3.1.1. (p 513) “if available, preference is given to EC10”. The lowest long-term threshold level is thus the EC10 to daphnid reproduction of 1.3 mg/L. Therefore none of the chronic category conditions is fulfilled.

In conclusion no classification for chronic (long-term) aquatic hazard is required.

C) Hazards to the ozone layer

The sole implemented Category 1 according to chapter 5.1.2.1. required if:

the available evidence concerning its properties and its predicted or observed environmental fate and behaviour indicate that it may present a danger to the structure and/or the functioning of the stratospheric ozone layer.

No such indications exist for the submission item, which is thus considered not hazardous to the ozone layer.

In conclusion no classification for hazards to the ozone layer is required.

D) Overall conclusion on environmental classification

In result the ecotoxicological threshold levels observed for the submission item fall above classifiable levels and it is considered not hazardous to the ozone layer.

Thus no classification for environmental hazards is required.

Table: Labelling elements based on the classification

Element

Code

GHS Pictogram

none

Signal Word

none

Hazard Statement

none

Precautionary statement(s)

none

 

  • ECHA European Chemicals Agency (2013). Guidance on the Application of the CLP Criteria. Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. Version 4.0. Self-published, Helsinki, Finland, in November. ISBN 978-92-9244-002-2 Reference ECHA-13-G-10-EN . 662 p.