Registration Dossier

Administrative data

Description of key information

Based on the information available, cumene is not a skin irritant and not eye irritant in terms of EU classification. In the EU RAR it was concluded that the pulmonary irritation response is weak.

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

Data on this endpoint are presented in Section 4.1.2.3 of the EU RAR (2001; page 54ff).

Based on the information available, cumene is not a skin irritant and not eye irritant in terms of EU classification. In the EU RAR it was concluded that the pulmonary irritation response is weak.

 

Skin

The key study for this endpoint was the skin irritation study performed by Ciba Geigy Corporation (1985, see robust study summary in IUCLID Section 7.3). In the study with albino rabbits an irritation score of 1.84 of max. 8 was observed after 24h. The effect was fully reversible within 72h.

This result is supported by other studies with rabbits, which has been also described in EU RAR: Monsanto Corporation (1985), and Smyth et al. (1951). In the more recent study, application of 0.5 ml undiluted cumene; 24 h exposure; the mean irritation score was: 1.9 (24, 72 h average); slight defeating effect-skin flaked off in seven to ten days, but there was no injury in depth.

Therefore, the substance is only slightly irritating to the skin and in terms of classification criteria is described as not irritating.

In the EU RAR indentified 4 other studies of skin irritation 3 of them in rabbit and one in cow. All results coincide in slightly irritating except the study done in cow, which result was moderate irritating. However, in this study the substance was applied 10-20 times over a period of 2 to 4 weeks. The study was not considered relevant in the course of this evaluation.

Eye

The key study for this endpoint was the irritation study performed by Ciba Geigy Corporation (1985, see robust study summary in IUCLID Section 7.3). Studies in rabbits reveal that the mean irritation score was 7.7 of max. 110, average (24h: 13, 48h: 6.5, 72 h: 3.5). The effect was reported to be fully reversible after 120h.

This result is supported by another study with rabbits, which has been also described in EU RAR: Monsanto Corporation (1978), note EU RAR cited Monsanto Company (1985), which has been identified to be the same study). In this study, application of 0.1 ml undiluted cumene, mean irritation score was 7.6 of 110 (24, 48, 72 h average), at 120 h the score was 0 of 110.

Therefore, the substance is described as not irritating to the eye in terms of classification criteria.

In the EU RAR identified 4 other studies of eye irritation. All of them, using rabbit and all results coincide in the EC classification as not irritant.

One studies, Wolf et al. (1956), revealed the result slightly irritant. Cumene was tested by introducing two drops of liquid onto the right eye ball. Visual observations of irritation and corneal injury (both internal and external) were made upon the treated eye at the following times after treatment: three minutes, one hour, and one, two and seven days. A 5% water solution of fluorescein dye was used to stain and render visible the external injury of the cornea in all observations after the first (three minutes). The response of rabbit's eyes to cumene caused perceptible irritation of the conjunctival membranes but no corneal injury. 

 

Respiratory tract

Regarding irritation of the respiratory tract no key study were identified. In the EU RAR two studies were cited. Exposure of 1480 ppm and more were found to have impact on respiratory rate. No effect was observed at 580 ppm. In the EU RAR it was concluded that the pulmonary irritation response is weak.

 

Corrosivity

The available in vivo data for irritation in animals indicate that cumene is not corrosive to the skin or eyes. The same conclusion has been drawn in the EU RAR.

Justification for classification or non-classification

The available data indicated that classification as skin and eye irritant is not warranted.