Registration Dossier

Administrative data

Description of key information

Skin irritation (in vivo): not irritating (method similar to OECD404)

Eye irritation not irritating (according to OECD405)

Respiratory irritation: not irritating (based on the non irritant properties of skin and 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 adverse effect observed (not irritating)

Additional information

Skin irritation

The skin irritating potential of Cyclaprop in rabbits was determined in an acute skin irritation study which was performed according to a method similar to OECD404. New Zealand White rabbits were exposed to Cyclaprop for 4 hours (semi-occlusive), after which the patch was removed and exposure sites wiped clean. The skin sites were assessed immediately after treatment and 24, 48 and 72 hours after treatment.

Cyclaprop produced a mild reaction 24 hours after treatment, which decreased at 48 and 72 hr. The mean erythema scores over the 24, 48 and 72 hour time period, were 0 (1 animal), 0.67 (4 animals) and 1 (3 animals). The mean edema scores over the 24, 48 and 72 hour time period, were 0 (1 animal), 0.67 (2 animals), 1 (4 animals), and 1.33 (1 animal). As all animals had scorings below 2.3, the test substance is not considered to be a skin irritant.

Eye irritation

The potential of Cyclaprop to cause eye irritation was determined according to OECD guideline 405. Four New Zealand White female rabbits were exposed to 0.1 ml of the undiluted test article in one of the eyes. The other eye served as a control. The eyes were examinated and the changes graded according to a numerical scale one hour, 24, 48, 72 hours after dosing. The animals showed very slight signs of irritation on the treated eyes. Mean corneal opacity, chemosis, and iris scores at the 24, 48, and 72 hour time point were 0 in all animals. Mean conjunctivae score was 0.33 in three animals and 0 in one animal. The effects seen in the one animal was reversible within one day. It is concluded that Cyclaprop is not an eye irritant.

Respiratory irritation

For respiratory irritation mostly human data are used for the assessment because no suitable in vitro or in vivo tests are available that can identify respiratory irritation (REACH guidance R.7.2.3). There are no human data available such as indicated in part R7.2.3 of the ECHA guidance that indicate respiratory reactions of the substance e.g. from consumer experience or occupational exposure. In addition, the substance is not corrosive or severely irritating (absence of classification and labelling for skin and eye irritation) which further minimizes the respiratory irritation hazard (REACH guidance: 7.2.1.2).

Justification for classification or non-classification

Based on the available corrosion and irritation information the substance does not need to be classified for skin, eye and irritation according to EU CLP (EC 1272/2008 and its amendments).