Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester

Oxidising properties

Administrative data

Endpoint:

oxidising solids

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

-

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester

EC Number:

609-496-9

Cas Number:

379685-94-6

Molecular formula:

C18H23F3N2O4

IUPAC Name:

Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester

Test material form:

solid: particulate/powder

Remarks:

Off white to beige powder with agglomerates

Specific details on test material used for the study:

- Analytical purity: 98.5% (HPLC)- Lot/batch No.: 0161045- Expiration date of the lot/batch: 2018/06/16

Study design

Contact with:

powdered cellulose

Results and discussion

Test results (Oxidising solids)

Test results (Oxidising solids) 1

Key result

Sample tested:

reference: 3:2 mixture potassium bromate + cellulose

Parameter:

burning rate

Result:

ca. 3.25 mm/s

Remarks on result:

other: mixture showing the highest burning rate

Test results (Oxidising solids) 2

Key result

Sample tested:

test mixture as specified

Remarks:

10% test substance

Parameter:

burning rate

Result:

ca. 2.83 mm/s

Remarks on result:

other: mixture showing the highest burning rate

Any other information on results incl. tables

Observations

All reference substance mixtures showed clear signs of oxidising properties (cracks, sparkling).

All test substance mixtures burned with orange flame and carbonized.

Burning Rates Reference Substance

In the following table, the measured data of the reference substance are presented.

Burning Rate of Reference Substance Mixtures

% Ba(NO3)2	Burning Time (s)	Burning Rate (mm/s)
50	66.03	3.03
60	61.47	3.25
70	75.32	2.66

Burning Rates Test Substance

In the following table, the measured data of the test substance mixtures are presented.

Burning Rate of Test substance Mixtures

% Test Substance	Burning Time (s)	Burning Rate (mm/s)
10	70.72	2.83
20	79.13	2.53
30	87.59	2.28
40	93.9	2.13
50	107.28	1.86
60	127.49	1.57
70	152.06	1.32
80	241.79	0.83
90	539.66	0.37

 

The mixture with 10 % test substanceMEXORYL SAR/20 shows the highest burning rate.

As the burning rate was lower than the highest burning rate of the reference substance mixtures, the determination of burning rate was repeated five times for each of the three mixtures test substance/cellulose with the highest burning rates.

The data are presented in the following tables.

Determination of burning rate mixture10/90% test substance / cellulose

Measurement	Burning Time (s)	Burning Rate (mm/s)
1	71.42	2.80
2	69.89	2.86
3	70.77	2.83
4	71.12	2.81
5	69.49	2.88
6(from first performance)	70.72	2.83
Mean		2.83
Standard Deviation in mm/s		0.03
Standard Deviation in %		1.05

Determination of burning rate mixture20/80% test substance / cellulose

Measurement	Burning Time (s)	Burning Rate (mm/s)
1	80.44	2.49
2	82.08	2.44
3	79.08	2.53
4	78.64	2.54
5	81.73	2.45
6(from first performance)	79.13	2.53
Mean		2.49
Standard Deviation in mm/s		0.05
Standard Deviation in %		1.82

Determination of burning rate mixture30/70% test substance / cellulose

Measurement	Burning Time (s)	Burning Rate (mm/s)
1	93.49	2.14
2	86.58	2.31
3	89.01	2.25
4	90.04	2.22
5	91.98	2.17
6(from first performance)	87.59	2.28
Mean		2.23
Standard Deviation in mm/s		0.06
Standard Deviation in %		2.90

Result

The highest burning rate of the three mixtures test substance/cellulose with the highest burning rate was determined to be 2.83±0.03 mm/s. The maximum burning rate of the reference substance was determined to be 3.25 mm/s. Therefore, the test substance is considered to have no oxidising properties.

Validity

The single determinations of the burning rate may not differ more than 10% from the respective arithmetic mean. The following deviations were calculated:

Deviations from the Mean

Mixture	Mean Burning Rate	Difference in % of Replicates
% test substance / % cellulose	in mm/s	1	2	3	4	5	6
10/90	2.83	1.2	-1.0	0.3	0.8	-1.5	0.2
20/80	2.49	0.3	2.3	-1.4	-1.9	1.9	-1.3
30/70	2.23	4.0	-3.6	-0.8	0.4	2.5	-2.4

None of the deviations surpasses 10%. Therefore, the study is considered as valid.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The highest burning rate of the three mixtures test substance/cellulose with the highest burning rate was determined to be 2.83 +/- 0.03 mm/s. The maximum burning rate of the reference substance was determined to be 3.25 mm/s. Therefore, the test substance is considered to have no oxidising properties.

Executive summary:

The oxidising properties of the test item (solid) was performed with a not-GLP compliant study, according to the EU method A.17. The highest burning rate of the three mixtures test substance/cellulose with the highest burning rate was determined to be 2.83 +/- 0.03 mm/s. The maximum burning rate of the reference substance was determined to be 3.25 mm/s. Therefore, the test substance is considered to have no oxidising properties.