(2S)-3-Methyl-2-[N-({2'-(1H-1,2,3,4-tetrazol-5-yl)-[1,1-biphenyl]-4-yl}methyl)pentanamido]alkanoic acid

Oxidising properties

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

oxidising solids

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the organic substance contains oxygen or halogen atoms which are chemically bonded only to carbon or hydrogen and hence, the classification procedure does not need to be applied

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
The statement as presented in the study report was based on the molecular structure of the substance. Full text of the statement: "A test item is considered an oxidizing substance(1) when the burning time of a mixture of the substance and cellulose in a 4:1 or 1:1 sample-to-cellulose ratio (by mass) is less than or equal to the mean burning time of a 3:7 reference mixture (by mass) of potassium bromate and cellulose.
The composition of the test item is shown in Paragraph 4.1. None of the components of the test item does contain groups that act as an oxidizing agent. The oxygen atoms that are present in the molecular structure of the test item are chemically bonded to carbon or hydrogen. In conclusion, VALSARTAN/DS has no oxidizing properties"

(1) According to the UN O.1 guideline.

Reference 2

Endpoint:

oxidising solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan 1997

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:

yes

Contact with:

powdered cellulose

Key result

Sample tested:

test mixture as specified

Remarks:

Test substance : Cellulose = 5 : 95

Parameter:

burning rate

Result:

1.7 mm/s

Remarks on result:

flaming

Key result

Sample tested:

test mixture as specified

Remarks:

Test substance : Cellulose = 10 : 90

Parameter:

burning rate

Result:

1.7 mm/s

Remarks on result:

flaming

Key result

Sample tested:

test mixture as specified

Remarks:

Test substance : Cellulose = 20 : 80

Parameter:

burning rate

Result:

1.6 mm/s

Remarks on result:

flaming

Interpretation of results:

GHS criteria not met

Conclusions:

The product is not considered an oxidizing substance.

Description of key information

JUSTIFICATION FOR DATA WAIVING

The statement as presented in the study report was based on the molecular structure of the substance. Full text of the statement: "A test item is considered an oxidizing substance(1) when the burning time of a mixture of the substance and cellulose in a 4:1 or 1:1 sample-to-cellulose ratio (by mass) is less than or equal to the mean burning time of a 3:7 reference mixture (by mass) of potassium bromate and cellulose.

The composition of the test item is shown in Paragraph 4.1. None of the components of the test item does contain groups that act as an oxidizing agent. The oxygen atoms that are present in the molecular structure of the test item are chemically bonded to carbon or hydrogen. In conclusion, VALSARTAN/DS has no oxidizing properties"

(1) According to the UN O.1 guideline.

Key value for chemical safety assessment

Oxidising properties:

non oxidising