Registration Dossier

Administrative data

Description of key information

Skin irritation / corrosion:
Primary skin irritation/corrosion study (OECD Guideline 404), rabbit: not irritating
Eye irritation:
Acute eye irritation/corrosion study (OECD Guideline 405), rabbit: not irritating

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

To determine skin irritating properties of the test substance, RDP was tested in the rabbit primary skin irritation/corrosion test in accordance with OECD Guideline 404. The right dorsal flank skin of 3 female albino rabbits was exposed to 0.5 ml of the test substance for 4 hours using semi-occlusive dressings. The test substance caused no adverse effects to the skin in any of the animals. The primary skin irritation index amounted to 0.

The eye irritating potential of the test material was tested in the rabbit acute eye irritation/corrosion test, performed according to OECD Guideline 405, 1987. Instillation of 0.1 ml of the test substance in one of the eyes of each of three albino rabbits resulted in adverse effects to the conjunctivae only. Approximately 60 min. after exposure, one animal showed slight reddening of the eyelids and slight chemosis, which resolved within 24 hours. No other adverse eye effects were observed in the treated animals, except for slight lacrimation on day 0.

Justification for classification or non-classification

According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC), and outlined in Annex I of 1272/2008/EC (CLP/EU-GHS), the test substance need not be labelled as a skin irritant nor an eye irritant.