Registration Dossier
Registration Dossier
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EC number: 946-927-2 | CAS number: -
Flammability
Administrative data
Link to relevant study record(s)
- Endpoint:
- flammable solids
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 23 to June 04, 2014
- 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:
- EU Method A.10 (Flammability (Solids))
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)
- Version / remarks:
- 5th edition, 2009
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected on 29 and 30 November 2010 / signed on 11 April 2011
- Key result
- Test procedure:
- burning rate test: preliminary screening test
- Remarks on result:
- substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period
- Interpretation of results:
- not classified based on GHS criteria
- Conclusions:
- The test item is NOT classified as a flammable solid according to Regulation (EC) N°1272/2008 (CLP) and UN GHS criteria.
- Executive summary:
The substance was tested for its flammable properties, according to EU-Method A.10 andUN MTC N1 guideline, and under GLP.
During the preliminary assay, the test item liquefied, boiled and burned with a yellow flame. The flame died immediately when the burner was removed.
Therefore no main test was performed and the substance is considered as NOT classified as a flammable solid according to Regulation (EC) N°1272/2008 (CLP) and UN GHS criteria.
- 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.
A review of the chemical structure of the known constituents of the substance suggests that there are no chemical groups present in these constituents that would imply pyrophoric properties. Moereover, the tests performed on the substance and reported in this dossier showed that the substance clearly does not react with air. Therefore, the study was considered as unnecessary. - 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 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.
A review of the chemical structure of the known constituents of the substance suggests that there are no chemical groups present that would imply flammability on contact with water. In addition, the information from aquatic test conducted on the raw material and analogue substance (Daphnia/algae aquatic toxicity tests conducted on labdanum gum and cistus concrete) showed that the tested substances clearly does not react with water. Therefore no reaction is anticipated on the registered substance.
Finally,no experience in handling and use of the extract has been reported, which could cast doubt on the NON-flammability if 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 a liquid
- 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.". As presented under section 4.1 and 4.2, the substance is described as a paste with a melting point between -1.3°C and 13.2°C. Therefore no test to determine self-heating properties is required.
Referenceopen allclose all
Since ignition did not occur within two minutes, the test item was classified as not highly flammable, and no determination of burning rate was necessary.
Safety Pre-Test
The test item liquefied, boiled and burned with a yellow flame.
Preliminary Screening Test
The test item liquefied, boiled and burned with a yellow flame. The flame died immediately when the burner was removed.
Therefore, no ignition was observed throughout the course of the test.
The test item should be considered as not highly flammable.
No observations were made which might cause doubts concerning the validity of the study outcome.
Description of key information
Flash Point : 65.5°C (exp) => NOT a flammable liquid according to Regulation (EC) N°1272/2008 (CLP) criteria
and classified as COMBUSTIBLE LIQUIDS, Category 4 according to UN Globally Harmonized System (GHS criteria) (see endpoint 4.11).
No propagation in contact with a flame => NOT a flammable solid (CLP/GHS).
NOT flammable if contact with air or water (waived).
NO self-heating properties anticipated (waived)
Key value for chemical safety assessment
- Flammability:
- not classified
Additional information
As the substance is described as a paste, two fully reliable experimental studies (for flammable solids and for flammable liquids) were conducted under GLP and are presented under point 4.11. and 4.13.
Both are considered as key studies.
Justification for classification or non-classification
The measured flash point (65.5°C) is above the threshold value of 60°C of Regulation (EC) No.1272/2008 (CLP) and below the threshold value of 93°C of UN Globally Harmonised System (GHS), therefore the test substance is NOT classified as a Flammable liquid under CLP but is classified as COMBUSTIBLE LIQUID, Category 4 under GHS.
The result obtained on this kind of substance should be largely influence by small amounts of volatile constituents.
In the preliminary test of the UN Test N.1 method, the substance did not propagate a flame. Therefore, the substance is NOT classified as a Flammable solid according to Regulation (EC) No.1272/2008 (CLP) and UN Globally Harmonised1 System (GHS) criteria.
Based on the chemical structure of the known constituents of the substance and experience in handling, testing and use of the substance, no flammable properties are anticipated if contact with air or water, therefore studies were deemed unnecessary in accordance with section 1 of REACh Annex XI.
Finally considering that the substance is a solid with a low melting point (<160°C), no classification as self-heating substance is anticipated.
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