Registration Dossier

Administrative data

Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 February 2018 to 17 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.10 (Flammability (Solids))
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: New Zealand Pharmaceuticals, 68 Weld Street, Palmerston North 4472, New Zealand (Batch No. 2216242)
- Expiration date of the lot/batch: 07 November 2021
- Purity: 91.2 % (07 November 2016)

Results and discussion

Flammable solids
Key result
Test procedure:
burning rate test: preliminary screening test
Remarks on result:
other: substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 4 minutes test period

Applicant's summary and conclusion

Interpretation of results:
not classified based on GHS criteria
Conclusions:
The test item is not highly flammable in preliminary screening test. Since the test item does not propagate 200 mm length within 4 minutes during the preliminary test, hence burning rate test was not carried out.
Executive summary:

In an EU A.10 (Flammability (Solids)) the test item Bile, Hydrolyzateswas arranged in the form of powder pile as train 250 mm long by 20 mm wide by 10 mm heightaluminium mouldon a non-combustible, non- porous and low heat conducting base plate. A hot flame from a burner (minimum diameter 5 mm) was applied to one end of the powder train until 2 minutes, the test item was not ignited and did not propagates 200 mm length within 4 minutes during the preliminary test. The preliminary tests were performed with two replicates.

The test item is not highly flammable in preliminary screening test.