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Diss Factsheets
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EC number: 228-067-3 | CAS number: 6107-56-8
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The substance is formed during the industrial process (it is a soap) and therefore there is no exposure via inhalation nor dermal.
Column 2 of Annex VIII 8.5 states: "In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided." Furthermore Column 2 of Annex VIII 8.5.2 states: "Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size."
The vapour pressure of the substance if very low (1 x 10-4 Pa at 25 °C) and a boiling point result was not possible to obtain as the substance decomposes before boiling, as such the substance is considered to be of low volatility. Furthermore the possibility of exposure to aerosols, particles or droplets of an inhalable size is not expected as the substance (soap) is formed within the production tank of the grease (mixture). This tank is closed, this process requires heating and the workers will not be in contact with the product whilst it is still hot.
Towards the end of the process, some workers could be in contact with the product during grinding, deaeration, and packaging. Contacts would essentially be by hands. – Workers wear PPE, including chemical gloves and safety glasses. Particle size distribution was not conducted as the substance is marketed or used in a non-solid or granular form and therefore exposure via the inhalation route is not expected.
In conclusion there is no expected exposure via the inhalation route and therefore an acute toxicity inhalation study is not considered to be necessary.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- vapour pressure
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 May 2018 to 25 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 104 (Vapour Pressure Curve)
- Version / remarks:
- Not reported
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.4 (Vapour Pressure)
- Version / remarks:
- Not reported
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- effusion method: isothermal thermogravimetry
- Test no.:
- #2
- Temp.:
- 25 °C
- Vapour pressure:
- 0 Pa
- Test no.:
- #3
- Temp.:
- 25 °C
- Vapour pressure:
- 0 Pa
- Temp.:
- 25 °C
- Vapour pressure:
- 0 Pa
- Remarks on result:
- other: Mean vapour pressure
- Conclusions:
- The vapour pressure of the test item was determined to be 1 x 10-4 Pa at 25 °C.
- Executive summary:
The vapour pressure of the test item was determined in a study following OECD 104 and EC Method A.4 guidelines, using the effusion method. The vapour pressure of the test item was determined to be 1 x 10-4 Pa at 25 °C.
The study is a GLP compliant, guideline experimental study and is fully acceptable for assessment of this endpoint.
For run 1, there was initial high weight losses at lower temperatures. This was indicative of degassing of the sample. Only the data from runs 2 and 3 have therefore been used for calculations.
Table 1: A summary of the run 2 and 3 results
Parameter | Run 2 | Run 3 |
Correlation (R2) | 0.9941 | 0.9965 |
Slope | -4134 | -4490 |
Intercept | 10.19 | 10.90 |
log10PT at 25 °C | -3.7 | -4.2 |
PT (Pa) at 25 °C | 0.00021 | 0.000069 |
Table 2: Vapour Pressure Measurements (Run 2)
Temperature (°C) | Evaporation rate, VT (g/minute) | log10VT | log10PT |
118.63 | 0.0000002613 | -4.098 | -0.3745 |
123.61 | 0.0000003556 | -3.964 | -0.2313 |
128.59 | 0.0000004873 | -3.827 | -0.0849 |
133.58 | 0.0000006356 | -3.712 | 0.0386 |
138.56 | 0.0000007712 | -3.628 | 0.1285 |
Table 3: Vapour Pressure Measurements (Run 3)
Temperature (°C) | Evaporation rate, VT(g/minute) | log10VT | log10PT |
123.64 | 0.0000002342 | -4.145 | -0.4253 |
128.61 | 0.0000003325 | -3.993 | -0.2625 |
133.58 | 0.0000004368 | -3.874 | -0.1357 |
138.55 | 0.0000005693 | -3.759 | -0.01259 |
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- boiling point
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is a solid which decomposes before boiling
- Justification for type of information:
- In accordance with column 2 of REACH Annex VII, the boiling point study does not need to be conducted as the substances decompose before boiling.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- particle size distribution (granulometry)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is marketed or used in a non solid or granular form
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VII, the granulometry study does not need to be conducted as the substance is marketed or used in a non-solid or granular form.
Data source
Materials and methods
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.