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Registration Dossier
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Diss Factsheets
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EC number: 947-717-3 | 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
Flammability
Administrative data
Link to relevant study record(s)
- Endpoint:
- pyrophoric solids
- 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 known to be stable in contact with air at room temperature for prolonged periods of time (days) and hence, the classification procedure does not need to be applied
- the study does not need to be conducted because the organic substance does not contain metals or metalloids and hence, the classification procedure does not need to be applied
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with section 1 of REACh Annex XI, study for pyrophoric properties is deemed unnecessary based on the experience in handling, testing and use of the substance and based on the chemical structure of the known constituents of the substance that do not fall into critical categories described in ECHA guidance.
The tests performed on the substance and reported in this dossier showed that the substance clearly does not react with air. Moreover, a review of the chemical structure of the known constituents suggests that there are no chemical groups present in these constituents that would imply pyrophoric properties. Therefore, the study was considered as unnecessary. - Endpoint:
- flammable solids
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 09 to 26 January 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was conducted according to an internationally recognised method, and under GLP. The substance is considered to be adequately characterised. Therefore full validation applies.
- Qualifier:
- according to guideline
- Guideline:
- UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)
- Version / remarks:
- 6th revised edition 2015
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP compliance programme (inspected on 05 July 2016 / signed on 28 October 2016)
- Key result
- Test procedure:
- burning rate test over 100 mm length
- Burning time:
- 39 s
- Interpretation of results:
- Category 1 (flammable solids) based on GHS criteria
- Conclusions:
- The test item has been determined to be a FLAMMABLE SOLID Cat.1. according to Regulation (EC) N°1272/2008 (CLP) and UN GHS criteria.
- Executive summary:
The study was conducted according the procedure Test N.1 of the United Nations Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria, 6th revised edition 2015.
First, a safety test was performed. A small amount of the test item was heated on board with a gas burner in order to derive safety precautions. The test item ignited and propagate along 200 mm.
Then, the main test was perfomed.
A rope was heated on a board and 1 ml of pure water was placed between 210 and 200 mm along the rope. The rope was burned with a gas burner and the rope ignited with a yellow flame and emitted black fumes.
As the burning time over 100mm is below 45 seconds (39 seconds) and the flame passes the wetted zone, the substance is considered as classified as a FLAMMABLE SOLID, Category 1 according to Regulation (EC) N°1272/2008 (CLP) and UN GHS criteria.
The test item has been determined to be a flammable solid, class 1, as it propagated combustion over the 100 mm of the main test in under 45.
- Endpoint:
- substances / mixtures which in contact with water emit flammable gases
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the organic substance does not contain metals or metalloids and hence, the classification procedure does not need to be applied
- the study does not need to be conducted because the experience in production or handling shows that the substance does not react with water, e.g. the substance is manufactured with water or washed with water
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with section 1 of REACh Annex XI, study for flammability if contact with water is deemed unnecessary based on the experience in handling, testing and use of the substance and based on the chemical structure of known constituents of the substance that do not fall into critical categories described in ECHA guidance.
The information from aquatic test conducted (fish/algae aquatic toxicity) showed that the substance clearly does not react with water. Moreover, a review of the chemical structure of the known constituents suggests that there are no chemical groups present that would imply flammability on contact with water. Therefore, the study was considered as unnecessary. - Endpoint:
- self-heating substances / mixtures
- 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 completely molten at 160°C
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING:
According to the Guidance on the Application of the CLP Criteria, v5.0 of July 2017, $ 2.11.4.2:
"the phenomenon of self-heating applies only to solids. The surface of liquids is not large enough for reaction with air and the test method is not applicable to liquids. Therefore liquids are not classified as self-heating…"
In addition,
"Substances or mixtures with a low melting point (< 160 °C) should not be considered for classification in this class since the melting process is endothermic and the substance-air surface is drastically reduced. However, this criterion is only applicable if the substance or mixture is completely molten up to this temperature."Considering that the test item is a brown waxy solid with a melting point < 160°C (see endpoint 4.2) the test is considered as not necessary.
Referenceopen allclose all
Results
Preliminary screening test
The rope ignited with a yellow flame and emitted black fumes. Burning rate: 60 seconds (across 200 mm). As the test item ignites and propagates combustion over 200 mm within two minutes , the substance is considered as Flammable and the main test is performed to determine the Hazard category.
Main test
The rope ignited with a yellow flame and emitted black fumes. Flame propagated through the wetted zone. Burning rate: 39 seconds (across 100 mm)
Description of key information
Flash Point = 98°C: NOT flammable liquid (CLP/GHS).
The result obtained on this kind of substance should be largely influence by small amounts of volatile constituents and this value doesn't represent the major part of the substance.
Calssified as a FLAMMABLE SOLID Category 1 (CLP/GHS)
Not flammable if contact with air or water (waived).
No self-heating anticipated for solid with a melting point < 160°C (waived).
Key value for chemical safety assessment
- Flammability:
- flammable
Additional information
Fully reliable GLP experimental studies are available:
Flammability of solids was evaluated according to UN N1 method, and is presented under point 4.13. Additionally, as a low melting solid, the substance was also tested for Flash Point according to ISO/EU closed cup method, and is presented under point 4.11. Both are considered as key studies.
First, a safety test was performed. A small amount of the test item was heated on board with a gas burner in order to derive safety precautions. The test item ignited and propagate along 200 mm.
Then, the main test was perfomed.
The test item should be considered as not highly flammable. A rope was heated on a board and 1 ml of pure water was placed between 210 and 200 mm along the rope. The rope was burned witha gas burner and the rope ignited with a yellow flame and emitted black fumes. Flame propagated through the wetted zone abd the burning rate was of 39 seconds (across 100 mm).
The test item has been determined to be a flammable solid, class 1, as it propagated combustion over the 100 mm of the main test in under 45.
Justification for classification or non-classification
According to Regulation (EC) No.1272/2008 (CLP) and UN Globally Harmonised System (GHS) criteria,the substance has to be classified as FLAMMABLE SOLID Category 1 since burning time over 100mm is below 45 seconds and the flame passes the wetted zone following UN Test N.1.
The measured flash point result is above the threshold values of 60°C ofRegulation (EC) No.1272/2008 (CLP) and 93°C of UN Globally Harmonised System (GHS), therefore the test substance is NOT considered as a flammable liquid under CLP and GHS.
Based on low melting point, no self-heating is anticipated and based on experience and chemical structure of known constituents of the substance, no flammable properties are anticipated if contact with air or water. Therefore additional studies were deemed unnecessary.
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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