Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritating, OECD TG 404; study "Arcelin Skin irritation / corrosion (in vivo "
Eye irritation: causes serious eye damage, OECD TG 437; study " Heppenheimer (2010) Eye irritation "
Respiratory irritation: no information available

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:
adverse effect observed (irritating)

Additional information

- skin irritation/corrosion:

One fully reliable in vitro study is available (Arcelin Skin irritation / corrosion (in vivo)) conducted according to OECD TG 404 and GLP using semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits.

The individual mean score for erythema/eschar and oedema for each of the three animals across 3 scoring times (24, 48 and 72 hours after patch removal) was 0.

The test item caused slight to marked blue staining of the treated skin in all animals up to 10 days after removal of the dressing and persisted in one animal up to the last day of observation (test day 15). Based on these results the substance is deemed not to be irritating.

 

- eye irritation/corrosion:

One fully reliable in vitro study is available (Heppenheimer (2010) Eye irritation) conducted according to OECD TG 437 and GLP using the Bovine Corneal Opacity and Permeability test.

FAT 40849/A TE induced severe ocular irritation through one endpoint (opacity), resulting in a mean in vitro irritancy score (IVIS) of 457.95 after 240 minutes of treatment. Since FAT 40849/A TE induced an IVIS >= 55.1, it is concluded that FAT 40849/A TE is corrosive or severe irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.

- respiratory irritation:

no data available


Effects on eye irritation: corrosive

Justification for classification or non-classification

- skin irritation/corrosion:

Based on the above stated assessment of the skin irritation potential of FAT 40849/A TE (individual mean score for erythema/eschar and oedema for each of the three animals across 3 scoring times = 0) the substance does not needto be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

 

- eye irritation/corrosion:

Based on the above stated assessment (IVIS >= 55.1) FAT 40849/A TE is to be classified as having irreversible effects on the eye (R41 Risk of serious damage to eyes) according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and Category 1 (Danger; H318: Causes serious eye damage) according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

 

- respiratory irritation:

As no data on respiratory irritation is available for FAT 40849/A TE a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.