Registration Dossier
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EC number: 224-594-8 | CAS number: 4422-95-1
Appearance / physical state / colour
Administrative data
Link to relevant study record(s)
- Endpoint:
- appearance / physical state / colour
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07-03-2022 to 02-05-2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Visual observation of physical state and appearance by the testing laboratory
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Visual observation of physical state and appearance by the testing laboratory
- GLP compliance:
- yes
- Physical state at 20°C and 1013 hPa:
- solid
- Remarks:
- Refer to 'Any other information on results incl. tables' for further information
- Key result
- Form:
- solid: crystalline
- Remarks:
- Refer to 'Any other information on results incl. tables' for further information
- Colour:
- white to pale yellow
- Substance type:
- organic
- Conclusions:
- The physical state and appearance of the test item were evaluated by visual observation. The test item was determined to be a white to pale yellow crystalline powder with some agglomerations (determined by test facility)
- Executive summary:
The appearance of the substance has been determined as:
Form: solid, crystalline
Colour: white to pale yellow
Applicant assessment indicates: two physical states/physical descriptions were provided by the sponsor and/or the test facility: (1) white to pale yellow liquid could crystallize (provided by the Sponsor) ; (2) white to pale yellow crystalline powder with some agglomerations (determined by test facility) (upon test item receipt). The test item melting point is low (< 40°C) and therefore is responsible for the difference in descriptions. Under CLP Regulation (EC) 1272/2008 and/or the Globally Harmonized System (GHS) revision 5 (2013), physical state is determined at 20°C and 'ambient pressure'. Therefore the test item should be considered as a 'white to pale yellow crystalline powder with some agglomerations' as was determined at approximately 20°C and atmospheric pressure. It is acknowledged that once melted at relatively low temperatures, the test item can take time to 'recystallize' and this is the reason for two appearances and/or physical states being generally acknowledged.
- Endpoint:
- appearance / physical state / colour
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-03-2022 to 28-04-2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Visual observation of physical state and appearance by the testing laboratory
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Visual observation of physical state and appearance by the testing laboratory
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: February 2022 ; signed: April 2022
- Physical state at 20°C and 1013 hPa:
- solid
- Remarks:
- Refer to 'Any other information on results incl. tables' for further information
- Key result
- Form:
- solid: crystalline
- Remarks:
- Refer to 'Any other information on results incl. tables' for further information
- Colour:
- white to pale yellow
- Substance type:
- organic
- Conclusions:
- The physical state and appearance of the test item were evaluated by visual observation. The test item was determined to be a white to pale yellow crystalline powder with some agglomerations (determined by test facility)
- Executive summary:
The appearance of the substance has been determined as:
Form: solid, crystalline
Colour: white to pale yellow
Applicant assessment indicates: two physical states/physical descriptions were provided by the sponsor and/or the test facility: (1) white to pale yellow liquid could crystallize (provided by the Sponsor) ; (2) white to pale yellow crystalline powder with some agglomerations (determined by test facility) (upon test item receipt). The test item melting point is low (< 40°C) and therefore is responsible for the difference in descriptions. Under CLP Regulation (EC) 1272/2008 and/or the Globally Harmonized System (GHS) revision 5 (2013), physical state is determined at 20°C and 'ambient pressure'. Therefore the test item should be considered as a 'white to pale yellow crystalline powder with some agglomerations' as was determined at approximately 20°C and atmospheric pressure. It is acknowledged that once melted at relatively low temperatures, the test item can take time to 'recystallize' and this is the reason for two appearances and/or physical states being generally acknowledged.
Referenceopen allclose all
- Physical state: (1) white to pale yellow liquid could crystallize (provided by the Sponsor) ; (2) white to pale yellow crystalline powder with some agglomerations (determined by test facility)
- Other: Two physical states/physical descriptions were provided by the sponsor and/or the test facility (upon test item receipt) ; applicant assessment indicates that the melting point is low (< 40°C) and therefore is responsible for the difference in descriptions
- Physical state: (1) white to pale yellow liquid could crystallize (provided by the Sponsor) ; (2) white to pale yellow crystalline powder with some agglomerations (determined by test facility)
- Other: Two physical states/physical descriptions were provided by the sponsor and/or the test facility (upon test item receipt) ; applicant assessment indicates that the melting point is low (< 40°C) and therefore is responsible for the difference in descriptions
Description of key information
Weight of evidence: State of the substance at 20 °C and 101.3 kPa: white to pale yellow crystalline solid, visual observation
Note: The substance may be also occasionally demonstrated as a 'white to pale yellow liquid' which may later crystallize, when having been previously melted (placed at temperatures above the melting point, ca. 36.9°C). This is potentially due to considerable time taken for recrystallization to occur when returned to temperatures below 20 °C.
Key value for chemical safety assessment
- Physical state at 20°C and 1013 hPa:
- solid
- Form:
- solid: crystalline
Additional information
The weight of evidence is that the substance is a white to pale yellow crystalline solid, and that the substance may be also occasionally demonstrated as a 'white to pale yellow liquid' which may later crystallize, when having been previously melted (placed at temperatures above the melting point, ca. 36.9°C). This is due to potentially considerable time taken for recrystallization to occur when returned to temperatures below 20 °C. It is generally acknowledged industrially that such substances can be considered ‘solid melt’ substances (i.e. substances that melt to a liquid at low temperature and remain liquid for some time).
The substance has been described the test sponsor and/or the test facility within available studies as : (1) white to pale yellow liquid could crystallize (provided by the Sponsor) ; (2) white to pale yellow crystalline powder with some agglomerations (determined by test facility) (upon test item receipt) under standard conditions of temperature and pressure. The colour of the substance may vary in available sources. No significant odour has been reported in available sources. The test item has a measured melting point of 36.9°C at 99.9 kPa and boiling range of 319.5 – 325.7°C at 99.9 kPa within an available study to EU Method A.1/A,2 under GLP.
The substance under the CLP Regulation (EC) 1272/2008: Annex 1, section 1 concerning the definition of gases, liquids and solids, does not meet the criteria as a gas or liquid. Physical state is determined at 20°C and 'ambient pressure'. The test item should be considered as a 'white to pale yellow crystalline powder with some agglomerations' as was determined at approximately 20°C and atmospheric pressure within two separate GLP studies conducted on two separate lot/batch numbers of the substance. Therefore should be considered as a solid.
References:
1. UN Transport of Dangerous Goods Manual of Tests and Criteria, Seventh Edition (2019)
2. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, July 2017)
3. REACH Regulation (EC) 1907/2006, Annex VII, section 7.1
4. CLP Regulation (EC) 1272/2008, Annex I, section 1
5. ECHA Guidance on Application on the CLP Criteria, section 2.0 (v5.0, July 2017)
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