Registration Dossier

Administrative data

Endpoint:
auto-ignition temperature (liquids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-01-31 to 2017-06-06
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:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.15 (Auto-Ignition Temperature (Liquids and Gases))
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Physical state: Viscous liquid
- Appearance: Yellow to orange, clear liquid
Specific details on test material used for the study:
- Batch n°: I16HB3200
- Analytical purity: 83.7%
- Expiration date: 2017-07-25
- Storage condition: at room temperature

Results and discussion

Auto-ignition temperature (liquids / gases)
Auto-ignition temperature:
405 °C
Atm. press.:
>= 1 027.7 - <= 1 028.7 hPa

Any other information on results incl. tables

Ignition of the test item within 5 minutes after introduction was observed with each sample volume and with each test a minimum auto-ignition temperature was obtained. The maximum deviation between the three 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 406°C. This temperature was rounded down to the nearest multiple of 5°C giving an auto-ignition temperature of the test item of 405°C.

 

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-17337008-AAA (T001591).

The test item is auto-ignitable with an auto-ignition temperature of 405°C at 1027.7 -1028.7 hPa.