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

Oxidising properties

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

oxidising 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.17 (Oxidising Properties (Solids))

Version / remarks:

- EEC Directive 84/449, A.17

GLP compliance:

yes

Contact with:

powdered cellulose

Key result

Sample tested:

other: reference: 3:2 barium nitrate/celull

Parameter:

maximum burning rate

Result:

3.1 mm/s

Remarks on result:

other: barium nitrate/cellulose 60:40

Key result

Sample tested:

other: test mixture 1:4

Parameter:

maximum burning rate

Result:

1.3 mm/s

Remarks on result:

other: test substance/cellulose 20:80, steady burning with flame through 3/5 of the mass

Key result

Sample tested:

other: test mixture 1:9

Parameter:

maximum burning rate

Result:

1.3 mm/s

Remarks on result:

other: test substance/cellulose 10:90, steady burning with flame through 4/5 of the mass

Sample tested:

test mixture as specified

Parameter:

maximum burning rate

Result:

0.8 mm/s

Remarks on result:

other: test substance/cellulose 30:70, only 1 of 6 tests propagates to second reference mark

The ratio between the maximum burning rate for the test mixture (20% of product) and the maximum burning rate of the reference mixture is 0.4.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is considered to have no oxidising properties.

Executive summary:

In a study according to EU Test Method A.17 the substance showed no oxisiding properties.

Reference 2

Endpoint:

oxidising 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 oxidising properties 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.17 (Oxidising Properties (Solids))

Version / remarks:

- EEC Directive 84/449, A.17

GLP compliance:

yes

Contact with:

powdered cellulose

Key result

Sample tested:

other: reference: 3:2 barium nitrate/celull

Parameter:

maximum burning rate

Result:

3.1 mm/s

Remarks on result:

other: barium nitrate/cellulose 60:40

Key result

Sample tested:

other: test mixture 1:4

Parameter:

maximum burning rate

Result:

1.3 mm/s

Remarks on result:

other: test substance/cellulose 20:80, steady burning with flame through 3/5 of the mass

Key result

Sample tested:

other: test mixture 1:9

Parameter:

maximum burning rate

Result:

1.3 mm/s

Remarks on result:

other: test substance/cellulose 10:90, steady burning with flame through 4/5 of the mass

Sample tested:

test mixture as specified

Parameter:

maximum burning rate

Result:

0.8 mm/s

Remarks on result:

other: test substance/cellulose 30:70, only 1 of 6 tests propagates to second reference mark

The ratio between the maximum burning rate for the test mixture (20% of product) and the maximum burning rate of the reference mixture is 0.4.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is considered to have no oxidising properties.

Executive summary:

In a study according to EU Test Method A.17 the substance showed no oxisiding properties.

Description of key information

The substance has no oxidising properties.

Key value for chemical safety assessment

Oxidising properties:

no

Additional information

In a reliable study according to EU Test Method A.17 the substance showed no oxisiding properties.

Justification for classification or non-classification

As the substance did not show any oxidising properties in a study according to EU Test Method A.17, no classification is required.