Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 210-519-6 | CAS number: 617-52-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Ecotoxicological Summary
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
- 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.
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.
Conclusion on classification
- 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.
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 |
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.