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Diss Factsheets

Administrative data

Endpoint:
oxidising solids
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.17 (Oxidising Properties (Solids))
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Loperamide
EC Number:
258-416-5
EC Name:
Loperamide
Cas Number:
53179-11-6
Molecular formula:
C29H33ClN2O2
IUPAC Name:
4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test item identification : 4-(4-clorofenil)-4-idrossi-N,N-dimetil-a,a-difenil-1--piperidinbutanamide
Purity : 99.7 % w/w
Expiry date : June 01, 2015

Results and discussion

Test results (Oxidising solids)open allclose all
Sample tested:
1:1 sample-to-cellulose ratio
Parameter:
burning rate
Result:
0.37 mm/s
Sample tested:
4:1 sample-to-cellulose ratio
Parameter:
burning rate
Result:
0.1 mm/s
Sample tested:
1:1 sample-to-cellulose ratio
Parameter:
burning time of reaction over a distance of 200 mm
Result:
539 s
Sample tested:
4:1 sample-to-cellulose ratio
Parameter:
burning time of reaction over a distance of 200 mm
Result:
1 987 s

Any other information on results incl. tables

Preliminary Test

The test item was mixed with dried cellulose in the proportion 2 to 1 (w/w) and the mixture was formed into a small cone shaped pile of 3.5 cm (diameter of base) x 2.5 cm (height) by filling, without tamping, a cone-shaped former. The pile was then placed on a cool, non combustible, non-porous and low heat-conducting base plate.

The ignition source was applied to the cone and the test item was liquefied without vigorous reaction.

Reference substance mixture with cellulose

The barium nitrate reference substance was mixed with dried cellulose in various ratios and tested as described in the experimental section above.

The maximum burning rate of the reference substance was achieved with barium nitrate mixed with dried cellulose in the proportion 40 to 60 (% w/w).

Test item mixture with cellulose

The test item was mixed with dried cellulose in various ratios and tested as described in the experimental section.

Mixture Test item/cellulose (% w/w) Burning time Burning rate

over 200 mm (sec) (mm/sec)

A 10 / 90 334 0.60

B 20 / 80 336 0.59

C 30 / 70 338 0.52

D 40 / 60 453 0.44

E 50 / 50 539 0.37

F 60 / 40 658 0.30

G 70 / 30 747 0.27

H 80 / 20 1987 0.10

I 90 / 10 burning does not propagate -

From these preliminary results, the test item could have oxidizing properties.

However, these results could be a false positive since the test item is a not highly flammable

substance.

In order to investigate the possible false positive hypothesis, the tests with the three fastest

mixtures (A, B and C) were repeated using kieselguhr (diatomaceous earth) as an inert

support instead of the combustible cellulose. If the test item is a true oxidizing substance, the

burning rate would be slower as the test item has no material to oxidize.

The test repeated on the same ratios with the test item, using kieselguhr as an inert support,

showed no propagation of the flame.

The presence of the cellulose resulted important for the burning of mixtures and since the

maximum burning rate of the three fastest mixtures A, B and C (0.60 mm/sec) is lower than

the maximum burning rate of the reference mixture with barium nitrate and cellulose (40/60,

0.66 mm/sec), the test item is to be consider as a non oxidizing substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
From the obtained experimental data according to the A.17 method in Council Regulation
(EC) No 440/2008 of 30 May 2008, it can be concluded that 4-(4-chlorophenyl)-4-hydroxy-
N,N-dimethyl-a,a-diphenyl sample is a non-oxidizing substance.