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Diss Factsheets

Physical & Chemical properties

Flammability

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Administrative data

Link to relevant study record(s)

Referenceopen allclose all

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)

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.

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)

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.

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.

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