Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 april 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
adopted July 27, 1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
capillary method

Test material

Constituent 1
Reference substance name:
Sulfates of potassium, sodium and calcium, byproduct from fermentation
Molecular formula:
SO42-, K+, Na+, Ca2+
IUPAC Name:
Sulfates of potassium, sodium and calcium, byproduct from fermentation
Test material form:
solid
Remarks:
light to beige solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EXP LIberica Lote Al16503047
- Expiration date of the lot/batch: 30 November 2019
- Purity test date: 1 February 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 deg Celsius, below 70% relative humidity) protected from light and humidity
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle:not specified

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was ground to a fine powder before the application. Sufficient water was used to dampen the test material to ensure good contact with the skin.

Results and discussion

Melting / freezing point
Key result
Melting / freezing pt.:
> 400 °C
Atm. press.:
ca. 1 atm
Decomposition:
ambiguous
Remarks:
No melting point was observed up to 400ºC, but the colour of test item changed about 300ºC from initial light beige to grey.
Decomp. temp.:
ca. 300 °C

Applicant's summary and conclusion

Conclusions:
No melting point was observed up to 400ºC, but the colour of test item changed about 300ºC from initial light beige to grey.
Executive summary:

The melting point of the test item was assessed with a GLP-compliant study, following the standardised guideline OECD TG 102, and EU method A.1 (capillary method). A small amount of the test item was heated in the electronic controlled sample block and the temperature around the sample was displayed. The sample was observed visually while raising the temperature. The initial and final melting temperatures were determined.

A preliminary test with three parallel samples was performed from 30°C to 400°C at 10°C/min heating rate.

For the main study three capillaries containing the test item were placed into the apparatus, the block was heated from 390°C to 400°C at 0.5°C/min heating rate. The transformations of the test item were observed, visually through the magnifying glass.

Three parallel experiments were carried out and in each case three parallel samples were measured.

No melting point was observed up to 400ºC, but the colour of test item changed about 300ºC from initial light beige to grey.

Categories Display