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Diss Factsheets
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EC number: 479-950-7 | CAS number: 31274-51-8
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 833.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point). This is in line with the ECHA R8 guidance document.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used. This is in line with the ECHA R8 guidance document.
- AF for other interspecies differences:
- 1
- Justification:
- Based on the absence of evident systemic/ organ specific toxicity up to and including the limit dose, an additional AF for interspecies differences other than allometric scaling is not considered necessary.
- AF for intraspecies differences:
- 3
- Justification:
- Substance specific assessment factor: No relevant adverse systemic effects were observed up to and including the limit dose of 1000 mg/kg bw/d. Due to the absence of such effects, intraspecies variations in toxicokinetics or toxicodynamics are not considered relevant. However an AF of 3 has been included to cover for remaining uncertainties of putative subpopulations, based on the following assessment. Additional generic argumentation: In an attempt to evaluate the intraspecies variability within the human population, the distribution of human data for various toxicokinetic and toxicodynamic parameters were examined (Hattis et al 1987, 1999; Hattis and Silver 1994; Renwick and Lazarus, 1998; see ECETOC TR No.86, 2003). These evaluations included data from ‘healthy adults’ of both sexes, as well as limited data from the young and elderly, mixed races and patients with various medical conditions such as cancer and hypertension. The data of Renwick and Lazarus (1998) and Hattis et al (1999) were based exclusively on human data and similar values were obtained within each percentile. Considering that the data analysed by these authors included both sexes, a variety of disease states and ages, the use of the 95thpercentile is considered sufficiently conservative to account for intraspecies variability in the general population. Thus, a default assessment factor of 5 was taken for the general population with a lower factor of 3 (i.e. closer to the 90thpercentile) for the more homogenous worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be adequate for a robust DNEL derivation.
- AF for remaining uncertainties:
- 1
- Justification:
- Substance specific assessment factor: Subchronic administration of ETH50 resulted in no adverse effects up to and including the limit dose. Since no human relevant organ specific toxicity has been observed, no additional AF covering toxicodynamic differences between rats and humans is considered necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute/short term exposure – systemic and local effects
The test item did not induce any relevant systemic adverse effects in the acute (oral, inhalation, dermal) and repeated dose (oral, dermal) toxicity studies. It did not induce skin or eye irritation and was not sensitising in the LLNA. As the test item did neither show acute systemic nor acute local toxicity, the derivation of acute DNELs for systemic and local effects is not considered mandatory.
Long-term exposure – systemic effects
Inhalation:
There are no relevant experimental data on repeated dose exposure by inhalation. For derivation of a long-term systemic inhalation DNEL, 10 mg/m3 has been defined. This value is based on the general dust limit value (TRGS 900, established by AGS (Ausschuß für Gefahrstoffe), published by the German BMAS (Bundesministerium für Arbeit und Soziales")), since ETH50 does not pose any intrinsic hazard. Furthermore, the substance characteristics (low vapour pressure, high melting point, very low water solubility) indicate that an inhalation absorption of toxicologically significant amounts of the test item is unlikely.
Dermal:
The NOAEL of 1000 mg/kg bw/d from the repeated dose dermal toxicity study in rats (CIT 32404 TCR, 2008) is used as starting point for the derivation of the long term systemic worker DNEL. This starting point represents a worst case assumption, since no evident systemic and organ specific toxicity has been observed up to and including the limit dose (1000 mg/kg bw/d).
Concerning dermal penetration potential between rat and human, two comparative in vitro dermal penetration studies are available for rat and human skin using ETH50 in non-/nano form (RCC A00112; RCC B23624). No evident species differences have been observed based on ETH50, that penetrated fully through human skin membranes into the perfusate independent from its form. However, including the fraction found in the remaining skin (excluding the stratum corneum) an approx. 20 fold higher level of ETH50 was found in rat skin compared to human skin. This ratio was comparable between the different specifications of ETH50, i.e. 1.38% vs. 0.06% and 5.07% vs. 0.28% of the applied ETH50 dose for the nano and non-nano form, respectively. Based on these differences in dermal absorption in humans and rat, the NOAEL from the the repeated dose dermal toxicity study in rats has been converted as follows:
NOAELcorr = dermal NOAEL * ABSdermal-rat/ABSdermal-human = 1000 mg/kg bw/d * 20 = 20000 mg/ kg bw/d.
Long-term exposure – local effects
The test item did not induce any local toxic effects. There was no evidence of toxicity in any of the available studies. Thus, the derivation of a long-term DNEL for local effects is not required. This is in line with the ECHA guidance document (2012).
References:
ECETOC (2010). Guidance on assessment factors to derive a DNEL. Technical Report 110.
ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characeterisation of dose[concentration]-response for human health. Version: 2.1, ECHA-2012 -G-19 -EN.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Based on the present toxicological data, the substance does not pose any hazard, leading to a non-classification according to the criteria laid down under67/548/ECC and CLP. Since all relevant uses are outside the scope of REACH and inside the scope of the Cosmetics Directive 76/768/EEC, no DNELS have been derived for the general population according to "Guidance on information requirements and chemical safety assessment (Chapter R8).
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.
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