Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Skin Irritation: not irritant; OECD 404, CIBA 1986c
Eye Irritation: not irritant; OECD 405, CIBA 1986d

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

There are valid in vivo data available for the assessment of the skin and eye irritation potential of Pyrrolo(3,4-c)pyrrole-1,4-dione, 2,5-dihydro-3,6-diphenyl-.

Skin: In a primary dermal irritation study (OECD 404, CIBA, 1986c), 3 female New Zealand White rabbits were dermally exposed to 0.5 mg of the test substance for 4 hours under occlusive conditions. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean score for the 24, 48 and 72 h reading for erythema and edema were 0. In this study, the test substance is not a dermal irritant.

Eye

An eye irritation test was performed with three New Zealand White rabbits according to OECD 405 (CIBA 1986d). Eyes were left unwashed after application of 0.1 g of the test substance and the animals were observed 72 h. The mean scores for the 24, 48 and 72 h reading for conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis were 0 at any reading time point.

 

Respiratory system

No data available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin and eye irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No. 1272/2008.