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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
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EC number: - | 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Remarks:
- The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. Hence, an in vitro study was conducted to build weight of evidence.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 Feb 2021 - 14 Apr 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- in vitro method. No standard guidelines available. Method sufficiently documented. Reliability 2
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test
The neutral red uptake (NRU) assay is used to determine cell viability as an indicator of acute toxicity. Neutral red penetrates cellular membranes, entering cells via non-ionic diffusion and accumulates intracellularly in lysosomes. Viable cells take up and retain the neutral red dye, while damaged or dead cells do not, therefore, the neutral red uptake assay can be employed as a direct measure of cell viability, using membrane integrity as the measured endpoint. Incorporated NR is released from the cells using a solubilization solution. The absorbance of the NR is quantified using a spectrophotometer.
- Short description of test conditions:
Neonatal human dermal fibroblast cultures (HDFn-XF) were obtained commercially as cryopreserved primary cells (Lifeline Cell Technology. Carlsbad, USA). They were originally derived from donor tissue with informed consent for the tissue to be used for research purposes, in adherence with the Human Tissue Act (UK) 2004. Xeno-free Fibrolife culture medium and sub-culture reagents (Cell Systems, Germany) are free of animal-derived components providing a fully human cell culture system.
- Parameters analysed / observed:
Viability - GLP compliance:
- no
- Remarks:
- Work conducted in the spirit of the GLP and in line with the lab's status as a GLP laboratory approv ed by the UK Medicines and Health Regulatory Authority (MHRA).
- Limit test:
- no
- Species:
- other: in vitro; neonatal human dermal fibroblast (HDFn-XF)
- Route of administration:
- other: cell culture
- Vehicle:
- other: No vehicle. cell culture medium was used as solvent
- Details on oral exposure:
- A single application of 8 concentration of the test item (n=6) was applied in cell culture medium (d
ilution factor of 5 in the range finder, 1.3 in the main test). The top concentration was previously
determined by solubility testing. - Doses:
- Range finder: 200,000; 40,000; 8000; 1600; 320; 64; 12.8; 2.56 ug/mL
Main test: 8000; 6153.85; 4733.73; 3641.33; 2801.022; 2154.63; 1657.41; 1274.93 ug/mL - Details on study design:
- A single application of 8 concentration of the test item (n=6) was applied in cell culture medium (dilution factor of 5 in the range finder, 1.3 in the main test). A single application of 8 concentrations of the positive control (n=6) was applied in cell culture medium (dilution factor 1.2). A single application of culture medium was applied as negative control (n=12).
- Statistics:
- Standard IC50 regression based calculation method.
- Preliminary study:
- None
- Dose descriptor:
- other: IC50
- Effect level:
- 723.28 other: ug/mL
- Based on:
- test mat.
- Remarks:
- Exposure duration 24+-1 hours
- Remarks on result:
- other: Main experiment 1: Invalid results due to high variability
- Key result
- Dose descriptor:
- other: IC50
- Effect level:
- 2 273.84 other: ug/mL
- Based on:
- test mat.
- Remarks:
- Exposure duration 24+-1 hours
- Remarks on result:
- other: Main experiment 2
- Dose descriptor:
- other: IC50
- Effect level:
- 1 189.98 other: ug/mL
- Based on:
- test mat.
- Remarks:
- Exposure duration 24+-1 hours
- Remarks on result:
- other: Main experiment 3. Test item was below 50% viable at all concentrations tested and IC50 was calculated by extrapolation. These results were not considered in the interpretation.
- Key result
- Dose descriptor:
- other: IC50
- Effect level:
- 2 867.11 other: ug/mL
- Based on:
- test mat.
- Remarks:
- Exposure duration 24+-1 hours
- Remarks on result:
- other: Main experiment 4
- Interpretation of results:
- other: Not classified under CLP based on corresponding LD50 values.
- Conclusions:
- The test substance was not classified under CLP based on corresponding LD50 values.
- Executive summary:
The neutral red uptake (NRU) assay is used to determine cell viability as an indicator of acute toxicity. Neutral red penetrates cellular membranes, entering cells via non-ionic diffusion and accumulates intracellularly in lysosomes. Viable cells take up and retain the neutral red dye, while damaged or dead cells do not, therefore, the neutral red uptake assay can be employed as a direct measure of cell viability, using membrane integrity as the measured endpoint. Incorporated NR is released from the cells using a solubilization solution. The absorbance of the NR is quantified using a spectrophotometer.
A single application of 8 concentration of the test item (n=6) was applied in cell culture medium (dilution factor of 5 in the range finder, 1.3 in the main test). A single application of 8 concentrations of the positive control (n=6) was applied in cell culture medium (dilution factor 1.2). A single application of culture medium was applied as negative control (n=12).
The endpoint was cell viability. IC50 was determined based on regression. In the 5 main experiments, 2 results were ignored because of the high variability in main experiment 1 and less than 50% viability at all concetrations in the main experiment 3. Based on the results in the other main experiments, the test subtance is not classified under CLP based on corresponding LD50 values.
Reference
GHS criteria used for comaprison of results:
IC50 (ug/mL) | Corresponding LD50 (mg/kg) | Statement | GHS criteria |
ND | 5-50 | Fatal if swallowed | Cat 1 and 2 |
< 10 | 50-300 | Toxic if swallowed | Cat 3 |
10-1000 | 300-2000 | Harmful if swallowed | Cat 4 |
>1000 | 2000-5000 | Potentially harmful if swallowed | Cat 5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- >= 2 000 - <= 5 000 mg/kg bw
- Quality of whole database:
- No study available on acute oral toxicity. Substance is used in cosmetics. In vitro study was conducted to build weight of evidence.
Additional information
Justification for classification or non-classification
The endpoint was cell viability. IC50 was determined based on regression. In the 5 main experiments, 2 results were ignored because of the high variability in main experiment 1 and less than 50% viability at all concetrations in the main experiment 3. Based on the results in the other main experiments, the test subtance is not classified under CLP based on corresponding LD50 values.
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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