Registration Dossier
Registration Dossier
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EC number: 284-656-5 | CAS number: 84961-66-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Nicotiana tabacum, Solanaceae.
Flash point
Administrative data
Link to relevant study record(s)
- Endpoint:
- flash point of flammable liquids
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Testing was conducted from 31 July to 1 August 2018.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was conducted according to an internationally recognised method, and under GLP. The test substance is adequately characterised. Therefore full validation applies.
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.9 (Flash-Point)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 3679 (Determination of flash point - Rapid equilibrium closed cup method)
- Version / remarks:
- 2015
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 4,5 and 6 July 2016/ Signed on 10 January 2017
- Type of method:
- equilibrium method closed cup
- Flash point apparatus:
- Setaflash apparatus
- Key result
- Flash point:
- 45 °C
- Atm. press.:
- 101.3 kPa
- Interpretation of results:
- Category 3 (flammable liquids) based on GHS criteria
- Conclusions:
- According to the various pre-tests that were performed, the lowest flash was observed at 45°C.
- Executive summary:
The study was performed in order to determine the flash point of test item according to EU A.9 guideline, using an equilibrium method with closed cup.
The test item is classified as flammable liquid according to Regulation (EC) 1272/2008 (CLP regulation) and UN Globally Harmonised System (GHS).
Reference
Results
Pre-tests
Several pre-tests were performed to estimate the flash point value.
The following table summarizes all the pre-tests that were performed.
Pre-test |
Program |
Temperature of introduction (°C) |
Observed Flash point (°C) |
|
Start temperature |
End temperature |
|||
1 |
25 |
55 |
23 |
/ |
2 |
55 |
85 |
24 |
55 |
3 |
45 |
75 |
24 |
45 |
4 |
40 |
70 |
24 |
/ |
5 |
45 |
75 |
40 |
/ |
6 |
70 |
100 |
65 |
70 |
7 |
70 |
100 |
65 |
70 |
8 |
55 |
85 |
50 |
55 |
9 |
55 |
85 |
50 |
55 |
10 |
50 |
80 |
45 |
50 |
11 |
45 |
75 |
40 |
45 |
12 |
40 |
70 |
35 |
/ |
13 |
40 |
70 |
35 |
/ |
It appears that the lowest flash point was observed at 45°C using 2 mL of the substance.
Flash is systematically observed during the first dipping of the ignitor into the cup (except for pre-test 5).
Flash is not observed all along the ramp if the first dipping of the ignitor occurs below 45°C.
Furthermore the flash point of the reference substances butanol and CRM respects the checking cards limits.
Discussion and Validation of the results
The measured flash point value for the reference substance butanol, 37.0°C is within the control cards limits and complies with the validation criteria of 37.7+/-1.0°C.
The flash point of the reference substances CRM, 76.0 °C respects also the checking cards limits and complies with the validation criteria of 75.5 +/- 2 °C
Therefore, the results are considered as valid.
Control of the performance of the Method
A flash point of 37.0°C was registered for the reference substance butanol (Batch N° JA052488)
A flash point of 76.0°C was registered for the Certified Reference Material (Batch N° 1162111a)
Description of key information
The flash point of test item was determined to be 45°C.
Test item is classified as flammable liquid category 3 according to Regulation (EC) 1272/2008 (CLP regulation) and UN Globally Harmonised System (GHS).
Key value for chemical safety assessment
- Flash point at 101 325 Pa:
- 45 °C
Additional information
A fully reliable experimental study, conducted according to EU A9 guideline is available.
It is considered as a key study, and the result is retained as key data.
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