L-Histidine Hydrochloride Monohydrate

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Administrative data

Endpoint:

relative self-ignition temperature (solids)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 2017 - Apr 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

Guideline:

EU Method A.16 (Relative Self-Ignition Temperature for 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

Relative self-ignition temperature (solids)

Key result

Remarks on result:

no self ignition observed under the test conditions

Applicant's summary and conclusion

Conclusions:

Based on the results obtained the test item is considered ‘not self-ignitable’.

Executive summary:

The self-ignition temperature of the test item was determined according to EC Guideline A.16.  Relative Self-Ignition Temperature for Solids.

The test was conducted using a temperature programmed laboratory oven, a stainless steel wire mesh cube, NiCr/NiAl thermocouples and a temperature recording device. The mesh cube was made from stainless steel wire mesh with 0.045 mm openings that was folded into an open topped cube with dimensions of 2×2×2 cm.  The cube was secured with a stainless steel wire.The test cube was filled with test item and placed in the center of the oven.  One thermocouple was placed at the center of the cube and the other between the cube and the wall of the oven wall to record the oven temperature.  The oven was heated from 20°C to 258°C at a rate of 0.5°C/minute. The temperature of the oven at which the sample temperature reaches 400°C by self-heating is given as the self-ignition temperature of the test item.  After the experiment, the sample was cooled and the consistency of the test item was determined.

Endothermic effects of the test item were observed at temperatures of > 148°C.  The effects were most likely obtained due to decomposition and/or reaction of the test item and not related to self-heating.  It demonstrated that the test item is not self-ignitable. After the experiment, the test item had turned into a expanded, charred residue and was collected in a container that was placed below the cube.  It indicated that the test item had been molten, decomposed and/or reacted during the experiment. Based on the results obtained the test item is considered ‘not self-ignitable’.