Registration Dossier

Diss Factsheets

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:
2016
Report date:
2016

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:
9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
EC Number:
213-563-4
EC Name:
9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
Cas Number:
981-34-0
Molecular formula:
C22H28O5
IUPAC Name:
17,21-dihydroxy-16-methyl-9,11-epoxypregna-1,4-diene-3,20-dione
Test material form:
solid: particulate/powder

Results and discussion

Test results (Oxidising solids)
Sample tested:
1:1 sample-to-cellulose ratio
Parameter:
burning time of reaction over a distance of 200 mm
Result:
84 s
Remarks on result:
other: see tables below

Any other information on results incl. tables

The barium nitrate reference substance was mixed with dried cellulose in various ratios and

tested as described in the experimental section above.

Data and results of the different mixtures are reported in Table 1.

The maximum burning rate of the reference substance mixture was achieved with barium

nitrate mixed with dried cellulose in the proportion 40 to 60 (w/w).

TABLE 1 Test conducted on reference substance mixtures

Barium nitrate/cellulose (%w/w)  Burning time over 200 mm (sec)  Burning rate (mm/sec)
 60/40  382  0.52
 50/50  330  0.61
 40/60  302  0.66
 0/100  315  0.63

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

experimental section.

Data and results of the different mixtures are reported in Table 2.

TABLE 2 Test conducted on test item mixtures

Mixture  Test item/cellulose (5 w7w)  Burning time over 200 mm (sec)  Burning rate (mm/sec)
 A  10/90  329  0.61
 B  20/80  285  0.70
 C  30/70  239  0.84
 D  40/60  287  0.70
 E  50/50  236  0.85
 F  60/40  293  0.68
 G  70/30  552  0.36
 H  80/20  burning does not propagate  -
 I  90/10  burning does not propagate  -

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

mixtures (from C to F) 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 results obtained for the mixtures with kieselguhr are reported in Table 3.

TABLE 3 Test conducted using kieselguhr on the fastest mixtures

Mixture  Tet item/Kieselguhr (% w/w)   Burning time over 200 mm (sec)   Burning rate (mm/sec)
C  30/70  burning does not propagate - 
 D  40/60   burning does not propagate  -
E  50/50  84  2.38
F 60/40  87  2.30

The test showed burning rates for mixtures E and F definitely faster than those observed

using the combustible cellulose while for mixture C and D the burning did not propagate.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was therefore not acting as an oxidizer but the “wick effect” was observed; i.e.
the test item melted when the ignition source was applied and became flammable in the presence of the solid carrier.
For mixtures C and D the test item ratios were too low to burn.