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Diss Factsheets

Administrative data

Endpoint:
oxidising solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08.09.2014 to 11.11.2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.17 (Oxidising Properties (Solids))
Version / remarks:
2008
GLP compliance:
yes (incl. QA statement)
Remarks:
Siemens AG, Prozess-Sicherheit, Industriepark Höchst, B 596 & B 598, D-65926 Frankfurt/M., Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
N6-(1-oxododecyl)-L-lysine
EC Number:
257-843-4
EC Name:
N6-(1-oxododecyl)-L-lysine
Cas Number:
52315-75-0
Molecular formula:
C18H36N2O3
IUPAC Name:
N6-(1-oxododecyl)-L-lysine
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Ajinomoto Co., Inc., 15-1, Kyobashi 1-chome, Chuo-Ku, Tokyo 104-8315 (Japan)/Batch No.: 130918
- Expiration date of the lot/batch: 17.09.2017
- Purity test date: 30.06.2014

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature (10-30°C)

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no

Study design

Contact with:
powdered cellulose

Results and discussion

Test results (Oxidising solids)
Key result
Sample tested:
other: test item - cellulose mixture: 10 wt.% test item
Parameter:
burning rate
Result:
<= 0.88 mm/s

Applicant's summary and conclusion

Conclusions:
The test item has no oxidizing properties.
Executive summary:

The oxidising properties of lauroyl L-lysine were investigated in a study conducted according to EU Method A.17 (Oxidising Properties (Solids); 2008). Based on the observations in preliminary tests, the main test had to be performed. In the main test, the highest burning rate of the reference mixture barium nitrate and cellulose was found to be 1.64 mm/s at 60 wt. % barium nitrate. The maximum burning rate of the mixtures of the test item and cellulose of 0.88 mm/s was found for a test item concentration of 10 wt. %. Based on these results (burning rate of test item (10 wt. %)/cellulose < burning rate of barium nitrate (60 wt. %)/cellulose) it ca be concluded that lauroyl L-lysine has no oxidising properties in the sense of the European Commission Regulation (EC) No. 440/2008, Method A.17.