Registration Dossier

Administrative data

Description of key information

A single study assessing each of the endpoints (skin and eye) was available. Both studies were awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). In the studies the substance was found not to warrant classification as an irritant to skin or eye.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN

A study was performed to assess the irritancy potential of the test material in accordance with the standardised guidelines OECD 404 and EU Method B.4 under GLP conditions.

A single application of 0.5 g of the test material moistened with 0.5 mL of distilled water was made to the clipped skin of 3 male New Zealand White rabbits. The skin was exposed in a semi-occlusive fashion for a period of 4 hours.

Following the exposure period, any residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale.

Very slight erythema was noted at all treated skin sites one hour after patch removal and at one treated skin site at the 24 and 48-hour observations. Very slight oedema was noted at one treated skin site one hour after patch removal.

All treated skin sites appeared normal 72 hours after treatment.

Under the conditions of this study the test material was determined to be non irritating to the skin

EYE.

The irritancy potential of the test material was investigated in a study conducted in accordance with the standardised guidelines OECD 405 and EU Method B.5 under GLP conditions.

A single application of the neat test material was made to the non-irrigated eye of three New Zealand White rabbits. One rabbit was initially treated. Immediately after administration of the test material an assessment of the initial pain reaction was made.

After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. In order to minimise pain on installation of the test material, one drop of local anaesthetic (Ophthaine, 0.5 % proxymetacaine hydrochloride) was instilled into both eyes of the third animal 1 to 2 minutes before treatment.

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize scale. Any other adverse ocular effects were also noted.

No adverse corneal effects were noted during the study. Iridial inflammation was noted in two treated eyes one hour after treatment; no other adverse iridial effects were noted. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation. No adverse ocular effects were noted 24 to 48 hours after treatment.

Under the conditions of this study the test material was found to be non irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
A single study assessing this endpoint was available. As such the results of this study have been used for chemical safety assessment.

Justification for selection of eye irritation endpoint:
A single study assessing this endpoint was available. As such the results of this study have been used for chemical safety assessment.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to irritation or corrosion to the skin and eye.