Cytidine 3'-(dihydrogen phosphate)

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:

May 15, 2017 - May 16, 2017

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

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: yes

Key result

Test procedure:

burning rate test: preliminary screening test

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

Table 1. Results of preliminary test

Test number	Time of burning [s]	Comments
Test-1	-	After the ignition the sample charred only in the place of applying the flame of burner. The sample did not ignite. Time of applying the flame of burner: 30, 60, 120 s. Result: NEGATIVE
Test-2	-
Test-3	-

 

Since the result is negative, it is not necessary to go to the next stage of determination.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not highly flammable according to test A.10 criteria.

Executive summary:

The study of determination of flammability was performed according to the EU Method A.10, following GLP. After application of the flame of burner for 30, 60 and 120 seconds, the sample does not ignite but it melts. The preliminary results were negative and therefore, it was not necessary to go to the next stage of determination. The test item is not highly flammable in accordance with test A.10 criteria.

Reference 2

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

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Study scientifically not necessary / other information available. The study does not to be conducted because the test 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. 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.

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

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Study scientifically not necessary / other information available. 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. The test substance is therefore regarded as not being flammable in contact with water.

Description of key information

Flammability: Key study. EU Method A.10. GLP study. The test item is not highly flammable.

Pyrophoric properties: Data waiving (study scientifically not necessary / other information available). 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.

Flammability in contact with water: Data waiving (study scientifically not necessary / other information available). The study not need to be conducted because the experience in production of handling shows that the substance does not react with water, e.g. the substance is manufactured with water or washed with water.

Key value for chemical safety assessment

Flammability:

not classified

Additional information

Flammability: Key study. The study of determination of flammability was performed according to the EU Method A.10, following GLP. After application of the flame of burner for 30, 60 and 120 seconds, the sample does not ignite but it melts. The preliminary results were negative and therefore, it was not necessary to go to the next stage of determination. The test item is not highly flammable in accordance with test A.10 criteria.

Pyrophoric properties: Data waiving (study scientifically not necessary / other information available). 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.

Flammability in contact with water: Data waiving (study scientifically not necessary / other information available). The study not need to be conducted because the experience in production of handling shows that the substance does not react with water, e.g. the substance is manufactured with water or washed with water.

Justification for classification or non-classification

Based on the available information, the test item is not classified for flammability according to CLP Regulation (EC) no. 1272/2008.