Registration Dossier

Administrative data

Description of key information

Irritation
- skin: not irritating (OECD 404)
- eyes: not irritating (OECD 405)

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

Skin Irritation

 

In vivo

In a primary dermal irritation study, performed according to protocols of the OECD TG 404, three (7 -9 weeks old) New Zeeland white rabbits, were dermally exposed to 0.5 ml of undiluted test substance (99%) for 4 hours. The test substance was applied semiocclusively to shaved intact skin. The skin of the animals was washed with water after exposure. Skin irritation was scored at 1, 24, 48, 72 hours after application using the Draize scoring system. No skin irritation or corrosion was caused by the 4 hour exposure. In this study, the test substance is not a dermal irritant (NOTOX B.V 2004; reliability = val 1)

 

 

Eye Irritation

In vivo

In a GLP study performed according to the protocols of the OECD TG 405, 0.1 ml undiluted test substance (99%) was instilled into the conjunctival sac of the eye of 3 New Zealand White rabbits (7 - 9 weeks). The other eye remained untreated and served as control. After 24-hour, the eyes were washed with 2% fluorescein in water (adjusted to pH 7.0). Eyes were scored for damage according to the Draize scoring system at the time points 1, 24, 48 and 72 hours after instillation of the test substance. No effect was observed for the parameters corneal opacity (mean score = 0) and iritis (mean score = 0). Slight redness was seen in all three animals starting 1 hour post application. 24 - 72 h mean score were 0.6 for erythema and 0.1 for edema. Effects were reversible within 72 h. The test substance is not an eye irritant (NOTOX B.V 2004; reliability = val 2).

Justification for classification or non-classification

The test substance does not meet the classification and labelling criteria as laid down in 67/548/EEC and 1272/2008/EEC (EU-GHS) for irritation.