Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin: Rabbit, 0.5 moistened test substance, occlusive, shaved, 4 hours: not irritating (GLP, OECD 404, RCC AG 1986a). 
Eye: Rabbit, 0.1 undiluted test substance (no washing out): not irritating (GLP, OECD 405, RCC AG 1986b).
The moistened and undiluted substance, respectively was not irritating to the skin and the eye of rabbits.

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 the test substance.

 

Skin irritation:

In a skin irritation study conducted GLP conform by RCC AG (1986a) according to the protocol of OECD 404 (1981), with polyethylene glycol 0.5 g moistened test substance (analytical purity not known) was applied to the shaved skin of 3 New Zealand White rabbits in an occlusive dressing for the exposure period of 4 hours. At the end of the exposure period the dressing was removed and the skin was flushed with luke warm tap water. Subsequently, the skin reaction was assessed at 1, 24, 48 and 72 hours intervals. No signs of skin irritation or skin corrosion were seen. No other signs of intoxication were observed. A severe red discoloration of the skin was observed in all animals during the whole observation period which was regarded to be related to effects of the red test article.

 

 

Eye irritation:

In a GLP conform eye irritation study, performed by RRC AG (1986b) according to OECD guideline 405 (1981), the 0.1 g of the undiluted substance (analytical purity not known) was applied to the eye of 3 New Zealand White rabbit. After an observation period of 24 h, 48 h and 72 h after application no irritation to eye was observed. Additionally, no clinical signs of systemic toxicity were observed and no mortality occurred. Red residues were observed at 1 h in all animals. No discoloration of the cornea and conjunctivae was observed.

 

Respiratory system:

There are no data available concerning the irritating potential of the test substance to the respiratory system.

 

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 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.

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