Registration Dossier
Registration Dossier
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EC number: 453-460-3 | CAS number: -
Melting point / freezing point
Administrative data
Link to relevant study record(s)
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 November 2015 to 29 January 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 102 (Melting point / Melting Range)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- pour point
- Key result
- Melting / freezing pt.:
- -15 °C
- Remarks on result:
- other: Pour point
- Conclusions:
- The pour point of the test item was determined to be -15 ± 3 °C (258 ± 3 K).
- Executive summary:
GUIDELINE
Pour point was determined using a method designed to be compatible with Method A.1 Melting/Freezing temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 102 of the OECD Guidelines for Testing of Chemicals 27 July 1995.
RESULTS
The pour point of the test item was determined to be -15 ± 3 °C (258 ± 3 K).
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Certificate of Analysis.
- Principles of method if other than guideline:
- No more details available about the method.
- GLP compliance:
- no
- Type of method:
- pour point
- Remarks:
- measured
- Melting / freezing pt.:
- -48 °C
- Remarks on result:
- other: Pour point
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Certificate of Analysis.
- Qualifier:
- according to guideline
- Guideline:
- other: FR060070
- GLP compliance:
- no
- Type of method:
- pour point
- Melting / freezing pt.:
- -54 °C
- Remarks on result:
- other: Pour point
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Certificate of Analysis.
- Qualifier:
- according to guideline
- Guideline:
- other: ASTM D 97
- GLP compliance:
- no
- Type of method:
- pour point
- Melting / freezing pt.:
- < -54 °C
- Remarks on result:
- other: Pour point
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: In-house data generated in accordance with recognised guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ASTM D97: Standard test method for pour point of petroleum products
- Deviations:
- no
- GLP compliance:
- not specified
- Melting / freezing pt.:
- -36 °C
- Remarks on result:
- other: Pour point
- Conclusions:
- The pour point of the test item was determined to be -36 °C.
- Executive summary:
The pour point of the test item was determined to be -36 °C.
- Endpoint:
- melting point/freezing point
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- To register EC453-460-3 under REACH program, a read-across approach for fulfillment of the endpoints has been adopted. EC453-460-3 is an aliphatic ester and fits the description of polyol esters category in HPV program (High Production Volume, US-EPA). The distinguishing feature of polyol esters category is that the fatty acids were linked to one or more of the multiple hydroxyl groups present in the polyol (alcohol portion of ester). The focus of this correspondence is to support read across to EC613-848-7 (target) which provided key studies to determine hazard profile of EC453-460-3 (target), published information on other structurally analogous polyol esters were served as supporting evidence.
- Reason / purpose for cross-reference:
- read-across source
- Type of method:
- pour point
- Melting / freezing pt.:
- -54 °C
- Remarks on result:
- other: Pour point
- Endpoint:
- melting point/freezing point
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- To register EC453-460-3 under REACH program, a read-across approach for fulfillment of the endpoints has been adopted. EC453-460-3 is an aliphatic ester and fits the description of polyol esters category in HPV program (High Production Volume, US-EPA). The distinguishing feature of polyol esters category is that the fatty acids were linked to one or more of the multiple hydroxyl groups present in the polyol (alcohol portion of ester). The focus of this correspondence is to support read across to EC613-848-7 (target) which provided key studies to determine hazard profile of EC453-460-3 (target), published information on other structurally analogous polyol esters were served as supporting evidence.
- Reason / purpose for cross-reference:
- read-across source
- Melting / freezing pt.:
- -48 °C
- Remarks on result:
- other: Pour point
- Endpoint:
- melting point/freezing point
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- To register EC453-460-3 under REACH program, a read-across approach for fulfillment of the endpoints has been adopted. EC453-460-3 is an aliphatic ester and fits the description of polyol esters category in HPV program (High Production Volume, US-EPA). The distinguishing feature of polyol esters category is that the fatty acids were linked to one or more of the multiple hydroxyl groups present in the polyol (alcohol portion of ester). The focus of this correspondence is to support read across to EC613-848-7 (target) which provided key studies to determine hazard profile of EC453-460-3 (target), published information on other structurally analogous polyol esters were served as supporting evidence.
- Reason / purpose for cross-reference:
- read-across source
- Type of method:
- pour point
- Melting / freezing pt.:
- < -54 °C
- Remarks on result:
- other: Pour point
- Endpoint:
- melting point/freezing point
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- To register EC453-460-3 under REACH program, a read-across approach for fulfillment of the endpoints has been adopted. EC453-460-3 is an aliphatic ester and fits the description of polyol esters category in HPV program (High Production Volume, US-EPA). The distinguishing feature of polyol esters category is that the fatty acids were linked to one or more of the multiple hydroxyl groups present in the polyol (alcohol portion of ester). The focus of this correspondence is to support read across to EC613-848-7 (target) which provided key studies to determine hazard profile of EC453-460-3 (target), published information on other structurally analogous polyol esters were served as supporting evidence.
- Reason / purpose for cross-reference:
- read-across source
- Melting / freezing pt.:
- -36 °C
- Remarks on result:
- other: Pour point
- Conclusions:
- The pour point of the test item was determined to be -36 °C.
- Executive summary:
The pour point of the test item was determined to be -36 °C.
Referenceopen allclose all
PRELIMINARY TEST
- The pour point determined during the preliminary test was -14 ± 3 °C (258 ± 3 K).
MAIN TEST
- The stationary points determined during the main test were -18.0 °C (Determination 1) and -18.0 °C (Determination 2).
- Pour points determined during the main test were -15.0 °C (Determination 1) and -15.0 °C (Determination 2).
- Overall pour point result was found to be -15 ± 3 °C (258 ± 3 K).
Description of key information
The pour point of the test item was determined to be -15 ± 3 °C (258 ± 3 K) (OECD 102 and EU Method A.1).
Key value for chemical safety assessment
- Melting / freezing point at 101 325 Pa:
- -15 °C
Additional information
GUIDELINE
Pour point was determined using a method designed to be compatible with Method A.1 Melting/Freezing temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 102 of the OECD Guidelines for Testing of Chemicals 27 July 1995.
RESULTS
The pour point of the test item was determined to be -15 ± 3 °C (258 ± 3 K).
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