Registration Dossier

Administrative data

Endpoint:
auto-ignition temperature (liquids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 March - 16 September 2017
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.15 (Auto-Ignition Temperature (Liquids and Gases))
Deviations:
no
Qualifier:
according to
Guideline:
DIN 51794 (Testing of mineral oil hydrocarbons - Determination of ignition temperature)
Deviations:
no
Qualifier:
according to
Guideline:
IEC 60079-4 (Electrical apparatus for explosive gas atmospheres. Part 4: Method of test for ignition temperature)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Details on test material:
Physical state: liquid
Appearence: light brown liquid
Specific details on test material used for the study:
- Batch n°: I16FB3013
- Analytical purity: 87.5%
- Expiration date: 07 June 2018
- Storage condition: at room temperature

Results and discussion

Auto-ignition temperature (liquids / gases)
Key result
Auto-ignition temperature:
400 °C
Atm. press.:
>= 999.4 - <= 1 017 hPa

Any other information on results incl. tables

Preliminary test

The estimated auto-ignition temperature was 415°C.

Main study

Ignition of the test item within 5 min after introduction was observed with each sample volume and with each test a minimum auto-ignition temperature was obtained. The maximum deviation between the 3 values was < 20°C. According to the guidelines, no further testing was required.

The lowest temperature at which ignition of the test item occurred was 402°C. This temperature was rounded down to the nearest multiple of 5°C giving an auto-ignition temperature of the test item of 400°C.

The test item is auto-ignitable with an auto-ignition temperature of 400°C at 999.4 - 1017.0 hPa.

Applicant's summary and conclusion

Conclusions:
Commercially available auto-ignition temperature apparatus was used for the determination of the degree of auto-ignitability of JNJ-42819543-AAA (T001596).

The test item is auto-ignitable with an auto-ignition temperature of 400°C at 999.4 - 1017.0 hPa.