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EC number: 947-990-9 | 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:
- flammable solids
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
From the statement of the referenced Chemistry Learning portal (see supporting information) it can be derived that it can be regarded as general knowledge that milk powder (and hence, very likely: also Bos taurus, milk, pasteurized, homogenized, skimmed, fermented, spray-dried) is not flammable as bulk substance. Furthermore, milk and yogurt powder need not be classified for transportation as an extensive websearch showed. This implies that a classification for flammability also with regards to CLP (same criteria as for transportation) is not warranted. In addition, experience in manufacture or handling shows that the bulk substance Bos taurus, milk, pasteurized, homogenized, skimmed, fermented, spray-dried does not ignite upon coming into contact with an ignition source at normal temperatures.
Hence the study for flammability does not need to be conducted on Bos taurus, milk, pasteurized, homogenized, skimmed, fermented, spray-dried. - Endpoint:
- pyrophoric solids
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- 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 substance is known to be soluble in water to form a stable mixture
- Justification for type of information:
- Based on the findings in the pre-test acc. to OECD 105 and the expert statement on water solubility, the substance has a water solubility in the range of 1-10 g/l and forms a stable solution.
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Endpoint:
- self-heating substances / mixtures
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 October - 27 November 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: UN Recommendations on the TRANSPORT OF DANGEROUS GOODS: Manual of Tests and Criteria
- Version / remarks:
- Rev. 6 (2015)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- UN Manual of Tests and Criteria: Test N.4 (Test method for self-heating substances)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch No.: 110219
Expiration date of batch: 07.03.2019
Content: 95.8% dry matter, 4.2% residual moisture
Storage conditions of the test material: 15 - 25°C, dry - Key result
- Test procedure:
- 100 mm sample cube at 140°C
- Result:
- positive outcome (effect observed)
- Key result
- Test procedure:
- 25 mm sample cube at 140°C
- Result:
- negative outcome (no effect observed)
- Key result
- Test procedure:
- 100 mm sample cube at 100°C
- Result:
- negative outcome (no effect observed)
- Interpretation of results:
- other: The test item is not classified as selfheating substance, if the test item is handled in containers with a volume of <0.45 m3. If the test item is handled in containers>0.45 m3, it must be classified as a self-heating substance and assigned to category 2.
- Conclusions:
- The test in the 100 mm cube sample at 140°C showed a self-heating of the test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) with a temperature increase of >60°C within 24 hours.
The test in the 25 mm cube sample at 140°C showed no self-heating of the test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) within 24 hours.
The test in the 100 mm cube sample at 100°C showed no self-heating of the test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) within 24 hours.
According to the results of three tests on self-heating in the Bowes-Cameron-Cage Test (UN-Test N.4) the test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) is classified as folIows:
UN Transport Regulation: The test item is not classified as self-heating substance in class 4, division 4.2 according to the UN Transport Regulation, if the test item is handled in containers with a volume of <0.45 m3. If the test item is handled in containers >0.45 m3, it is classified as self-heating substance in class 4, division 4.2 and assigned to packing group III.
GHS / CLP Regulation EC 1272/2008 Annex 1: 2.11: The test item is not classified as selfheating substance according to GHS/CLP Regulation EC 1272/2008 Annex 1: 2.11, respectively, if the test item is handled in containers with a volume of <0.45 m3 . If the test item is handled in containers >0.45 m3, it must be classified as a self-heating substance and assigned to category 2. - Executive summary:
Three Bowes-Cameron Cage Tests on self-heating were conducted on the test item
Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0)
The test in the 100 mm cube sample at 140°C showed a self-heating of the test item
Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0)
with a temperature increase of > 60°C within 24 hours.The test in the 25 mm cube sample at 140°C showed no self-heating of the test item
Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0)
within 24 hours.The test in the 100 mm cube sample at 100°C showed no self-heating of the test item
Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0)
within 24 hours.According to the results of three tests on self-heating in the Bowes-Cameron-Cage Test (UN-Test N.4) the test item
Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0)
is classified as folIows:UN Transport Regulation: The test item is not classified as self-heating substance in class 4, division 4.2 according to the UN Transport Regulation, if the test item is handled in containers with a volume of <0.45 m3 . If the test item is handled in containers >0.45 m3, it is classified as self-heating substance in class 4, division 4.2 and assigned to packing group III.
GHS / CLP Regulation EC 1272/2008 Annex 1: 2.11: The test item is not classified as selfheating substance according to GHS/CLP Regulation EC 1272/2008 Annex 1: 2.11, respectively, if the test item is handled in containers with a volume of <0.45 m3 . If the test item is handled in containers >0.45 m3 , it must be classified as a self-heating substance and assigned to category 2.
- Endpoint:
- self-heating substances / mixtures
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 July - 22 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.10 (Flammability (Solids))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: VDI2263
- Version / remarks:
- sheet 1
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Recommendations on the Transport of Dangerous Goods: Manual of Tests and Criteria
- Version / remarks:
- 6th edition, New York and Geneva, 2015: Class 4, Division 4.2: Substances which may be
liable to spontaneous combustion - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch No.: 110219
Content: 95.8 % Dry matter 4.2 % Residual moisture
Storage Conditions: Storage temperature 15 - 25°C, dry
Production date: 2018-02-24
Expiry date: 2019-03-07 - Key result
- Test procedure:
- other: 8 cm3 wire basket starting at 160°C
- Max. temp. reached:
- 735
- Result:
- positive outcome (effect observed)
- Key result
- Test procedure:
- other: 8 cm3 wire basket up to 412°C
- Result:
- negative outcome (no effect observed)
- Key result
- Test procedure:
- other: 8 cm3 wire basket starting at 180°C
- Remarks:
- mixture with Kieselguhr (1:1)
- Max. temp. reached:
- 300
- Result:
- positive outcome (effect observed)
- Remarks:
- only small effect
- Key result
- Test procedure:
- other: 8 cm3 wire basket up to 412°C
- Remarks:
- mixture with Kiesguhr (1:1)
- Result:
- negative outcome (no effect observed)
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The pure test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734-0) indicated a self-heating at atmospheric pressure starting at a temperature of 160°C. This self-heating process led to a maximum temperature of approx. 735°C (corresponding oven temperature 250 °C).
On the basis of the results of the tests on the self-ignition in the Grewer Oven a classification of the test item as self-heating substance cannot be excluded. Further tests according to UN Test N.4 have to be performed for the classification. Please refer to the Bowes-Cameron-Cage tests for the results of further tests. - Executive summary:
In the Grewer Oven test, the pure test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) indicated a self-heating at atmospheric pressure starting at a temperature of 160 °C. This self-heating process led to a maximum temperature of approx. 735°C (corresponding to oven temperature 250°C).
On the basis of the results of this test a classification of the test item as self-heating substance cannot be excluded. Further tests according to UN Test N.4 have to be performed for the classification. Please refer to the Bowes-Cameron-Cage tests for the results of further tests.
Referenceopen allclose all
140°C, 100 mm cube sample:
The temperature in the centre of the sample exceeded the oven temperature by over 360 K (cut-off temperature 500°C) within approximately 7 hours test time before the temperature in the centre of the sample could reach storage temperature of 140 °C. Since the temperature increase is above the threshold of 60 °C within 24 hours the result of the test is positive. Due to the positive result in the 100 mm cube sample at an oven temperature of 140 °C further tests had to be performed.
140°C, 25 mm cube sample:
The temperature in the centre of the sample did not exceed the oven temperature within a storage time of 48 hours. Since the temperature increase is below the threshold of 60 °C within 24 hours the result of the test is negative. Due to the negative result in the 25 mm cube sample at an oven temperature of 140 °C further tests had to be performed.
100°C, 100 mm cube sample:
The temperature in the centre of the sample did not exceed the oven temperature within a storage time of 48 hours. Since the temperature increase is below the threshold of 60 °C within 24 hours the result of the test is negative. Due to the negative result in the 100 mm cube sample at an oven temperature of 100 °C further tests do not have to be performed.
In the investigation of self-ignition in the Grewer Oven for the pure test item an exothermic process was detected starting at a temperature of approx. 160 °C that led to a maximum temperature of approx. 735 °C (corresponding oven temperature 250 °C). No further thermal effects could be observed up to the maximum test temperature of approx. 412 °C. After the measurement a grey to black residue remained in the wire basket.
For the test item in mixture with Kieselguhr a small exothermic process was detected starting at a temperature of approx. 180 °C that led to a maximum temperature of approx. 300 °C (corresponding oven temperature 280 °C). No further thermal effects could be observed up to the maximum test temperature of approx. 412 °C.
Description of key information
Flammability solid:
From the statement of the referenced Chemistry Learning portal (see supporting information) it can be derived that it can be regarded as general knowledge that milk powder (and hence, very likely: also Bos taurus, milk, pasteurized, homogenized, skimmed, fermented, spray-dried) is not flammable as bulk substance. Furthermore, milk and yogurt powder need not be classified for transportation as an extensive websearch showed. This implies that a classification for flammability also with regards to CLP (same criteria as for transportation) is not warranted. In addition, experience in manufacture or handling shows that the bulk substance Bos taurus, milk, pasteurized, homogenized, skimmed, fermented, spray-dried does not ignite upon coming into contact with an ignition source at normal temperatures.
Hence the study for flammability does not need to be conducted on Bos taurus, milk, pasteurized, homogenized, skimmed, fermented, spray-dried.
Self-heating:
In the Grewer Oven test, the pure test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) indicated a self-heating at atmospheric pressure starting at a temperature of 160 °C. This self-heating process led to a maximum temperature of approx. 735°C (corresponding to oven temperature 250°C).
On the basis of the results of this test a classification of the test item as self-heating substance cannot be excluded. Further tests according to UN Test N.4 had to be performed for the classification.
Three Bowes-Cameron Cage Tests on self-heating were conducted on the test item
Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0).
The test in the 100 mm cube sample at 140°C showed a self-heating of the test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) with a temperature increase of > 60°C within 24 hours.
The test in the 25 mm cube sample at 140°C showed no self-heating of the test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) within 24 hours.
The test in the 100 mm cube sample at 100°C showed no self-heating of the test item Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) within 24 hours.
According to the results of three tests on self-heating in the Bowes-Cameron-Cage Test (UN-Test N.4) the test item
Bos taurus, milk, pasteurized, homogenized, skimmed fermented, spray-dried (EC 917-734 -0) is classified as folIows:
UN Transport Regulation: The test item is not classified as self-heating substance in class 4, division 4.2 according to the UN Transport Regulation since the test item is handled in containers with a volume of <0.45 m3.
GHS / CLP Regulation EC 1272/2008 Annex 1: 2.11:The test item is not classified as selfheating substance according to GHS/CLP Regulation EC 1272/2008 Annex 1: 2.11, respectively, since the test item is handled in containers with a volume of <0.45 m3 .
Pyrophoric solid : The study does not need to be conducted as experience in manufacture or handling shows that the substance or mixture does not ignite spontaneously on coming into contact with air at normal temperatures.
Substances which in contact with water emit flammable gases: the study does not need to be conducted because the substance is known to be soluble in water to form a stable mixture. Based on the findings in the pre-test acc. to OECD 105 and the expert statement on water solubility, the substance has a water solubility in the range of 1-10 g/l and forms a stable solution.
Key value for chemical safety assessment
- Flammability:
- not classified
Additional information
Justification for classification or non-classification
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.