Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis(4-chlorophenyl)-2,5-dihydro-

Flammability

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

Version / remarks:

- EEC Directive 84/449, A.10

GLP compliance:

yes (incl. QA statement)

Key result

Test procedure:

burning rate test: preliminary screening test

Remarks on result:

other: brief ignition, rapid extinction, no spreading of fire.

The substance shows brief ignition, rapid extinction, no spreading of fire.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is considered to be not highly flammable.

Executive summary:

based on the results of a study according to EU Test Method A.10, the test substance is considered to be not highly flammable.

Reference 2

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

GLP compliance:

no

Test procedure:

burning time (test type not further specified)

Remarks:

not specified in description of method

Burning time:

ca. 120 s

Interpretation of results:

other: not highly flammable

Conclusions:

In a study according to EU Test Method A.10, the substance was not highly flammable.

Executive summary:

In a study according to EU Test Method A.10, the substance was not highly flammable.

Reference 3

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across is performed between two forms of the same substance. The identities of the two forms are describe below.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source form is 3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrol-1,4-dione (EC-no. 401-540-3), referred to here as PR254. PR254 is an organic mono-constituent substance with a typical purity of > 99.5% (w/w). It does not contain any impurity relevant for classification or labelling of the substance. The target form is the nanoform of the source substance, referred to here as PR254 nanoform. As the source form, it has a typical purity of > 99.5% (w/w) and it does not contain any impurity relevant for classification or labelling of the substance. The PR254 nanoform is spheroidal with a pure polyhedral shape and is not surface-treated.

3. ANALOGUE APPROACH JUSTIFICATION
The two analogue forms have the same structure. Under ambient atmosphere, the specific surface energy of particles increases with decreasing particle size. Therefore, particle aggregate to reach an energy minimum. The driving forces are hydrogen bonds and van der Waals forces (π-π interaction). Substantial energy is required to disperse the PR254 nanoform aggregates to particles that fall under the nanoform definition.
PR254 was been tested extensively addressing information requirements of Annexes VII to IX without identifying any biological target. PR254 nanoform could potentially have biological targets due to the different particle size distribution, which would require processes capable of dispersing the aggregates, e.g. in aqueous milieu. However, both forms have been tested according to OECD Test Guideline 318, demonstrating that PR254 nanoform cannot be dispersed under the condition of the study, i.e. immediately after sonification re-forms aggregates. Also, PR254 aggregates to a large extent, but can be more easily dispersed than the nanoform. The experiments demonstrated that exposure in aqueous milieu will be primarily to aggregates, regardless of the PR254 form.
Therefore, it is concluded that both forms will behave identically in studies, in which they are applied under atmospheric conditions and/or in aqueous milieus, so that for the PR254 nano-form no specific biological targets need to be considered.
Most physico-chemical properties (PCP) are inherent properties of a substance, which are not affected by the substance form. In addition, many PCP are determined starting the experimental procedure under ambient conditions, at which both forms have a similar particle size distribution. Therefore, the flammability will also be similar and the read-across from the source to the target form is scientifically justified.

4. DATA MATRIX
The data matrix is included as Annex 1 in the assessment report ‘PR254 bulk nano analogue approach 210111’ attached here below under ‘Attached justification’.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

Version / remarks:

- EEC Directive 84/449, A.10

GLP compliance:

yes (incl. QA statement)

Key result

Test procedure:

burning rate test: preliminary screening test

Remarks on result:

other: brief ignition, rapid extinction, no spreading of fire.

The substance shows brief ignition, rapid extinction, no spreading of fire.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is considered to be not highly flammable.

Executive summary:

based on the results of a study according to EU Test Method A.10, the test substance is considered to be not highly flammable.

Description of key information

The substance is not highly flammable.

Key value for chemical safety assessment

Flammability:

not classified

Additional information

In two reliable studies (without or with limitation) according to EU Test Method A.10, the

substance was not highly flammable.

Justification for classification or non-classification

As the substance was not flammable in two tests according to EU Test Method A.10, no classification is required.