Registration Dossier

Administrative data

Description of key information

The submission substance was found to be non-irritating to the skin and eyes during two separate studies on the New Zealand White Rabbit.

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

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. the method used was OECD Guideline 404. A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced no irritation. All treated skin sites appeared normal at the 24 -hour observation.

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit following OECD Guideline 405. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48 -hour observation.

Reliability

The above studies have all been ranked reliability 1 according to the scoring system from Klimish at al. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Justification for classification or non-classification

The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations during the dermal irritation study.

The test material did not meet the criteria for classification as an irritant (to the eye) according to the EU labelling regulations. No symbol or risk phrases are required.