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Diss Factsheets
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EC number: 943-834-9 | CAS number: -
- 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
Long-term toxicity to fish
Administrative data
- Endpoint:
- fish, juvenile growth test
- Type of information:
- experimental study planned
- Justification for type of information:
- Testing proposal for long-term aquatic toxicity study on fish (OECD 215):
Name of the substance on which testing is proposed to be carried out: Dried Sludge From Domestic Wastewater
According to EU/1907/2006 a long-term toxicity testing on fish is required to be conducted for substances that are to be registered in the tonnage band 100 or higher, if the chemical safety assessment according to annex I indicates the need to investigate further the effects on aquatic organisms. Based on the solubility test conducted, the substance is considered to be highly insoluble and thus the short-term toxicity study is not appropriate to indicate the aquatic toxicity profile of the substance in relation to the examined trophic level (fish). As a result, the short term toxicity test on fish is waived. A testing proposal for a “Fish, juvenile growth” test is made since all the general adaptation possibilities of Annex XI of the REACH Regulation are not adequate to generate the necessary information (see below):
- Available GLP studies
A short-term toxicity study on fish is triggered at a lower tonnage band (Annex VIII). However, due to the insolubility of the dried sludge (<0.5 mg/L), short term tests are not appropriate so as to accurately examine the aquatic toxicity of the substance.
- Available non-GLP studies
No non-GLP study that can fulfill the requirement of Long term toxicity test on fish are available.
- Historical human/control data
No historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies are available for the dried sludge from domestic waste. More specifically, none of the following types of human data are available:
• Analytical epidemiology studies on exposed populations
• Descriptive or correlation epidemiology studies
• Case reports describe a particular effect in an individual or a group of individuals exposed to the substance
• Controlled studies in human volunteers
• Information from occupational surveillance
• Postmarketing surveillance data
• Meta-analysis
- (Q)SAR
(Q)SAR models heavily rely on the chemical structure of the examined substance. However, the composition of Dried Sludge from Domestic Wastewater has not been fully identified (approximately 20% remains unknown) and the identified part is expressed in terms of grouping into generic substance categories (proteins, lipids, inorganic content etc.). As a result, (Q)SAR models cannot be used in the specific case to fulfill the requirement of long-term toxicity study.
- In vitro methods
According to ECHA's Guidance R7b there are no EU / OECD guidelines for in vitro test of relevance to aquatic toxicity.
- Grouping and read-across
Considering the technical difficulties that the specific UVCB substance entails (highly insoluble, abundancy of components), the identification was conducted on the basis of identifying general group categories, such as proteins, lipids, inorganic content, water etc. Subsequently, being technically impossible to identify specific compounds, no grouping can be made based on similar physicochemical toxicological, and ecotoxicological properties of substances and no data from other studies could be exploited so as to fulfill the long term aquatic toxicity test on fish requirement.
- Weight of evidence
A weight of evidence approach cannot be adopted since no read across, Q(SAR) model, adequate in vitro methods or human historical data are available so as to support the specific strategy.
- Substance-tailored exposure driven testing
Testing in accordance with Section 9.1.6 of Annex IX could have been avoided based on the exposure scenario developed and by fulfilling the criteria of point 3.2.a. of Annex XI of REACH Regulation. However, no data regarding the aquatic toxicological profile of the substance in relation to fish population are available so as to compute an appropriate PNEC and fulfill the second criteria of the endpoint 3.2.a.
Furthermore, the substance is not incorporated in an article nor strictly controlled conditions as set out in Article 18(4)(a) are implemented, so as to take advantage of either the endpoint 3.2.b or 3.2.c.
The OECD 215 – Fish Juvenile Growth Test is proposed to be conducted so as to fulfill the requirement of long-term toxicity test on fish.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 215 (Fish, Juvenile Growth Test)
Test material
- Reference substance name:
- A dried sludge product resulting from the treatment process of domestic wastewater. The exact processes followed for the production of the dried sludge are: Preliminary & secondary treatment of the wastewater stream, thickening, dehydration and drying of the excess sludge.
- EC Number:
- 943-834-9
- Molecular formula:
- Not applicable for UVCB substances
- IUPAC Name:
- A dried sludge product resulting from the treatment process of domestic wastewater. The exact processes followed for the production of the dried sludge are: Preliminary & secondary treatment of the wastewater stream, thickening, dehydration and drying of the excess sludge.
Constituent 1
Results and discussion
Applicant's summary and conclusion
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.