Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Physical & Chemical properties

Flammability

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
substances / mixtures which in contact with water emit flammable gases
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the experience in production or handling shows that the substance does not react with water, e.g. the substance is manufactured with water or washed with water
other:
Conclusions:
JNJ 39453349-AAA (T003066) has no pKa values for acidic and basic groups in the logarithm range of 1 – 14.
Endpoint:
pyrophoric solids
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is known to be stable in contact with air at room temperature for prolonged periods of time (days) and hence, the classification procedure does not need to be applied
other:
Endpoint:
self-heating substances / mixtures
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 November 2016 to 17 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Batch n°: I16CB1581
- Analytical purity: 98.61 %
- Expiration date: 2019-04-04
- Storage condition: at room temperature
Key result
Test procedure:
burning rate test: preliminary screening test
Remarks on result:
substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period

In contact with the flame of the gas burner the test item melted, emitted yellow sparks and turned into a brown residue. After removal of the ignition source, no propagation of combustion of the test item was observed.

According to the guidelines, performance of the burning rate test is not required. Based on the results obtained, the test item is considered ‘not readily combustible’ (i.e. ‘not flammable’).

Interpretation of results:
not classified based on GHS criteria
Conclusions:
The preliminary screening test was performed for the determination of the flammability of JNJ-3945349-AAA (T003066).

No propagation of combustion of the test item along 200 mm length of the pile within 2 minutes was observed. According to the guidelines, performance of the burning rate test is not required. Based on the results obtained, the test item is considered 'not readily combustible' (i.e. ‘not flammable’).
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Although the study was not performed according to an OECD or EC guideline, the used methodology is adequate and sufficient to conclude on the 'flammability solids' endpoint. However, no information on purity of the substance is reported.
Qualifier:
according to guideline
Guideline:
other: VDI Guideline 2263 Part 1, Burning behaviour: Test Methods for the Determination of the Safety Characteristic of Dusts (May 1990)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: ESCIS Expert Commission for Safety in the Swiss Chemical Industry, Booklet 1 ”Sicherheitstests fur Chemikalien" (1998)
Deviations:
yes
Remarks:
30 min conditioning instead of 1 hour
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified

At 20 deg C and at 100 deg C there is a brief ignition and a rapid extinction (class 2).

Conclusions:
There is no spreading of fire (class 1 to 3) since at 20 deg C and at 100 deg C there is a brief ignition and a rapid extinction (class 2).

Description of key information

The flammability potential of T003066 was determined in a GLP study according to the UN N.1 Method (K1, Reingruber, 2017). According to the results of the preliminary test, performance of the burning rate test was not required. T003066 is considered as not readily combustible (i.e. not flammable). Furthermore, T003066 is not considered a pyrophoric or self-heating substance or a substance which emits flammable gases after contact with water.

Key value for chemical safety assessment

Flammability:
not classified

Additional information

A supporting study is available performed by the Janssen Pharmaceutica Process Safety Center (2008). In this study no spreading of fire (class 1 to 3) was observed since at 20 deg C and at 100 deg C there is a brief ignition and a rapid extinction (class 2).

Justification for classification or non-classification

The substance does not need to be classified as flammable based on the preliminary test according to UN N.1. In addition, the substance is not considered to be pyrophoric, self-heating nor as a substance which emits flammable gases in contact with water (no tests performed, waiving).