Metformin hydrochloride

Oxidising properties

Link to relevant study record(s)

Reference

Endpoint:

oxidising solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25.11.-01.12.2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.17 (Oxidising Properties (Solids))

GLP compliance:

no

Contact with:

powdered cellulose

Key result

Sample tested:

test mixture as specified

Parameter:

preliminary test

Remarks on result:

other: mixture extinguished or could not be ignited depending on concentration

Remarks:

The test item had no oxidizing properties in the sense of Regulation (EC) No. 440/2008.

Main test

Four tests were performed for the reference mixture (BaNO3 and cellulose) with 50, 55, 60 and 70 weight % oxidiser. The highest burning rate of 1.72 mm/s was found for the mixture with 55 % oxidiser.

Mixtures of the test item with cellulose were prepared between 10 and 90 wt % of the test item and tested. Due to the fact that the maximum burning rate of the mixtures of the test item with cellulose was lower than the maximum burning rate of the reference mixture, six tests were performed only with the mixture with the highest burning rate (10 wt% of the test item) to verify these values. The mixtures with the next two higher concentrations were repeated twice to confirm their behaviour (no burning during the main burning phase).

Test	t [s]	V [mm/s]	t [s]	V [mm/s]	t [s]	V [mm/s]	t [s]	V [mm/s]	t [s]	V [mm/s]	t [s]	V [mm/s]
10%	17*	(0.41)	-	-	-	-	18*	(0.22)	-	-	27*	(0.44)
20 %	-	-	-	-	-	-	x	x	x	x	x
30 %	-	-	-	-	-	-	x	x	x	x	x	x

*The mixtures extinguished after 7 mm, 4mm and 12 mm.

The maximum burning rate of the mixtures of the test item and cellulose (0.44 mm/s, conservative approach) was less than the maximum burning rate of the reference mixture of cellulose and barium nitrate (1,72 mm/s). Due to the fact that the mixture of the test item with cellulose burned slower compared to the reference mixture it was concluded that the test item has no oxidising properties.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item had no oxidizing properties in the sense of Regulation (EC) No. 440/2008.

Executive summary:

The test item had no oxidizing properties in the sense of Regulation (EC) No. 440/2008.

Description of key information

The maximum burning rate of the mixtures of the test item and cellulose (0.44 mm/s, conservative approach) was less than the maximum burning rate of the reference mixture of cellulose and barium nitrate (1,72 mm/s). Due to the fact that the mixture of the test item with cellulose burned slower compared to the reference mixture it was concluded that the test item has no oxidising properties.

Key value for chemical safety assessment

Oxidising properties:

non oxidising