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Diss Factsheets
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EC number: 701-402-5 | 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
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
The ‘Column 2: Specific Rules for Adaptation from Column 1’ given in Annex IX of Regulation (EC) No. 1907/2006 (REACH) states that, the long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. In accordance with this provision, long term toxicity test with fish is considered to be scientifically not necessary as the chemical safety assessment performed using the available information from short term and chronic aquatic toxicity tests (96h LC50 to fish: >1000 mg/L; 48h EC50 to Daphnids: 1600 mg/L; 72h EC50 to algae: 184 mg/L and 72h NOEC to algae 50.6 mg/L) indicates no hazard is to be expected to fish. This conclusion was further supported by estimation of chronic value to fish using ECOSAR v2. The lowest chronic value to fish was estimated to be > 700 mg/L based on Ecosar estimation. This value may be considered not to be conservative as the chemical safety assessment performed with the algal EC50 184 mg/L and the application of assessment factor 10000 will result in lower or more conservative estimate of PNECs.
Predicted Ecotox values using the Estimation Programs Interface (EPI) SuiteTM developed by the US Environmental Protection Agency's Office of Pollution Prevention and Toxics and Syracuse Research Corporation (SRC).
Sl. No |
Parameter |
QSAR tool used for prediction |
Endpoint value |
1 |
Chronic toxicity to Fish |
ECOSAR Version 2 |
ChV: 771.59 mg/l |
2 |
Chronic toxicity to Daphnia |
ECOSAR Version 2 |
ChV: 29475.47mg/l |
3 |
Chronic toxicity to Green Algae |
ECOSAR Version 2 |
ChV: 10462.01 mg/l |
Further, in accordance with Section 3.2(a) under ‘Substance Tailored Exposure Driven Testing’ given in Annex XI of Regulation (EC) No. 1907/2006 (REACH), the exposure assessment and chemical safety assessment fulfils the requirements for waiving of the long term aquatic toxicity tests as discussed below:
i) No significant exposure to aquatic species is expected from all exposure scenarios of DMPPA_701-402-5, as nearly all wastewater from manufacturing and processing is sampled and incinerated as hazardous waste. Also no uses for professional workers and/or consumers are advised.
ii) The Predicted No Effect Concentrations (PNECs) were derived from available aquatic toxicity studies using the most sensitive endpoint (72h EC50 to algae: 184.8 mg/L). To account for the uncertainty arising out of using of a short term toxicity value instead of a long term value, a large assessment factor (1000 instead of 100 for freshwater species and 10000 instead of 1000 for marine water species) was used.
iii) The PECs from exposure assessment were always below the derived PNECs using aquatic toxicity data (0.184 mg/L for freshwater species; 0.0184 mg/L for marine water species). Hence, this resulted in RCRs for all exposure scenarios being less than 0.13.
Thus taking into account the provisions of ‘Specific Rules for Adaptation’ from Annex IX and Section 3.2(a) under ‘Substance Tailored Exposure Driven Testing’ from Annex XI of REACH Regulation, the long term toxicity testing with fish (and/or aquatic vertebrates) is considered to be scientifically not necessary and waived off.
Key value for chemical safety assessment
Additional information
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.