L-Histidine Hydrochloride Monohydrate

Flammability

Administrative data

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15JAN2018 to 15APR2018

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-Histidine Hydrochloride Monohydrate

EC Number:

611-821-4

Cas Number:

5934-29-2

Molecular formula:

C6-H9-N3-O2.Cl-H.H2-O

IUPAC Name:

L-Histidine Hydrochloride Monohydrate

Test material form:

solid: crystalline

Details on test material:

- Name: L-Histidine Hydrochloride Monohydrate (HHM)
- Appearance: White crystals or crystalline powder
- Batch: P817T011
- CAS no.: 5934-29-2
- Purity/Composition: 100.1%
- Molecular weight: 209.63 g/mol
- Test item storage: room temperature
- Expiry date: 31 October 2020

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: P817T011
- Expiration date of the lot/batch: 31 October 2020
- Purity: 100.1%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature

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

Conclusions:

No propagation of combustion of the test item along 200 mm length of the pile within 4 minutes was observed.

Executive summary:

The preliminary screening test was performed for the determination of the flammability of the test item accroding to EC Guideline A.10. Flammability (Solids). UN Test N.1.  Test Method for Readily Combustible Solids.  2015. The test item was loosely filled into an aluminium mould of 250 mm long with a triangular cross-section of inner height of 10 mm and width of 20 mm.  On both sides of the mould in a longitudinal direction two metal plates were mounted as lateral limitations that project 2 mm beyond the upper edge of the triangular cross section.  The mould was dropped three times from a height of 2 cm onto a solid surface.  If necessary, the mould was filled up again.  The lateral limitations were removed and the excess substance was scraped off.  A non-combustible and non-porous plate was placed on top of the mould.  The complete assembly was inverted and the mould removed. A flame of a gas burner was applied to one end of the test item pile until the test item ignited.  The pile was visually interpreted for propagation of combustion either by burning with a flame or smouldering.  If applicable, the time of burning over a distance of 200 mm was measured after the pile had burned a distance of 50 mm.

The flame of the gas burner did ignite the test item pile.  The test item melted, froth, glowed, expanded, burned with a blue yellow flame and turned into a black charred residue.  White smoke was observed.  After removal of the ignition source, the flame extinguished after 1 second and no propagation of combustion was observed.   No propagation of combustion of the test item along 200 mm length of the pile within 4 minutes was observed.  According to the guidelines, performance of the burning rate test is not required.  Based on the results obtained, the test item is considered ‘not highly flammable’.