Phenoxymethylpenicillin potassium

Flammability

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 June 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, sixth revised edition;Test N.1: Test method for readily combustible solids, 2015

Qualifier:

according to guideline

Guideline:

UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)

Version / remarks:

2015

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Name: Pen V Potassium
Lot No.: B519322
Appearance: white, solid powder
Expiry date:30 April 2024
Storage condition: at room temperature, protected from light

Key result

Test procedure:

burning time over 250 mm for metal powders or metal alloys

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

Remarks:

In the preliminary test the test item could not be ignited.

Interpretation of results:

not classified based on GHS criteria

Conclusions:

In the preliminary test the test item could not be ignited. The test item is considered as a not readily combustible solid of Division 4.1.

Executive summary:

In the preliminary test the test item could not be ignited. Based on the results of the preliminary test, no main test was performed.The test item is considered as a not readily combustible solid of Division 4.1.

Reference 2

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study (EC A.10.) with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: UN Transport Regulation Test N.1

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Manufactured by the Subimitter,
Batch number B 526734
Purity > 95%

Key result

Test procedure:

burning rate test: preliminary screening test

Remarks:

Combustion Class Number (BZ = Brennzahl) 2: Short burning and rapid extinguishing

Burning time:

s

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 product has to be classified neither as highly flammable solid according to EC 440/2008, Part A, A.10., nor as readily combustible solid in class 4.1 according to the UN-Transport Regulation and nor as flammable solid according to GHS.

Executive summary:

The product has to be classified neither as highly flammable solid according to EC 440/2008, Part A, A.10., nor as readily combustible solid in class 4.1 according to the UN-Transport Regulation and nor as flammable solid according to GHS.

Reference 3

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 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

Reference 4

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

Description of key information

Flammability:

The test item is not a flammable solid.

 

Flammability in Contact with Water:

The practical experience of the sponsor and the test facility shows that no gases are developed, when the test substance is in contact with water.

 

Pyrophoricity:

The test was not performed experimentally because practical experience exists at the sponsor and the test facility, e.g. when handling small amounts of the test substance repeatedly in air during testing. The test substance is therefore regarded as not being pyrophoric.

Key value for chemical safety assessment

Flammability:

not classified

Justification for classification or non-classification

No results were obtained to justify a classification.