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Diss Factsheets
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EC number: 939-688-0 | 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological and ecotoxicological properties because
• they are manufactured from similar precursors under similar conditions
• they share structural similarities and common functional groups
• the analytical descriptors show comparable results
• the metabolism pathway leads to comparable products (amine backbone and long chain fatty acids) and non-common products predicted to have no toxicological effects (long chain fatty acids).
This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively and quantitatively the same type of effects - of the read-across assessment framework i.e. properties of the target substance C1618FA-TEPA-compound are predicted to be similar to those of the source substances Partially unsaturated IQAC, DMS quaternised and oleic acid based IQAC, DMS quaternised.
Based on the available experimental data, the read-across strategy is supported by close structural analogy as well as similar toxicological profiles.
Therefore, read-across from the existing sub-chronic toxicity studies and pre-natal developmental toxicity as well as ecotoxicological studies on the source substance is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to detailed Justification for read-across attached to Iuclid section 13
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to detailed Justification for read-across attached to Iuclid section 13
4. DATA MATRIX
Please refer to detailed Justification for read-across attached to Iuclid section 13 - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Test organisms (species):
- Daphnia magna
- Test type:
- semi-static
- Water media type:
- freshwater
- Total exposure duration:
- 48 h
- Test temperature:
- 21°C
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.7 mg/L
- 95% CI:
- >= 2.6 - <= 4.9
- Nominal / measured:
- estimated
- Conc. based on:
- other: water accommodated fractions (WAFs)
- Basis for effect:
- mobility
Reference
Description of key information
The nominal 48–hr-acute toxicity of Partially unsaturated IQAC, DMS quaternised to Daphnia magna under semi-static conditions was EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits (OECD 202). The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 3.7 mg/L
Additional information
Experimental data on short-term toxicity to aquatic invertebrates of C1618FA-TEPA-compound are not available. However, short-term, toxicity studies in Daphnia magna were conducted with the structurally related source substance Partially unsaturated IQAC, DMS quaternised. A justification for read-across is attached to Iuclid section 13.
The 48–hr-acute toxicity of the closely related Partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied according to OECD Guideline for Testing of Chemicals, No. 202 (2004) under semi-static conditions. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs) for 48 hr. Immobilization effects were observed at 24h and 48 h. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits were calculated by Weibull analysis using linear maximum likelihood regression. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L. The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations.
In another study, the 24–hr-acute toxicity of the partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied under static conditions. Daphnids were exposed for 24 hr according to DIN 38 412 Part 11. Mortality/immobilization was observed. The 24 – hour EC50was 0.45 – 0.9 mg a.i../L. The 24 – hr EC0 based on mortality/immobilization/sublethal was 0.09 mg a.i. /L. The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna more than 10 000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.
According to REACH Endpoint specific Guidance R.7b, pp 24, 24 hour values can have considerable variability in the repeatability of results. Therefore standard 48 hour values are favoured over 24 hour values. 24 hour values should only be used in the absence of good quality 48 hour values with other available supporting data.
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.
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