Registration Dossier

Administrative data

Description of key information

There is adequate data to assess the irritant potential of LCCPs. In a study of  liquid C20-30 LCCPs, 0.5 ml neat LCCP, which included several stabilisers, was applied as a single occlusive application for 24 hours to abraded and non-abraded skin. Erythema and oedema was scored after 24 and 72 hours. Slight erythema was observed on both the abraded and non-abraded skin in two out of six rabbits at 24 hours.  In another study, up to 6 applications of 0.1ml of either liquid or solid LCCPs, either neat or in a non-irritating vehicle, were applied to the shorn back of 3 female rats on alternate 24-hour periods. It was concluded that these test materials wereas non-irritant. Single exposure to MCCPs also caused slight irritation in standard tests, but somewhat more pronounced irritation has been reported following repeated exposure, presumably due to defatting properties. In the absence of studies on repeated application of C18-20 LCCPs to skin, a conservative assumption is made that the C18-20 LCCPs could have a similar effect. There is no data on respiratory irritation of LCCPs, but this is  not be anticipated to be significant exposure route.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

LCCP have been shown to be, at most, only slightly irritatating to the skin and eyes in experimental animals. Skin and eye irritation have been investigated in animal studies for a number of LCCP products. These studies suggest that LCCPs have the potential to cause slight irritation.

 

Single exposure to MCCPs also caused slight irritation in standard tests, but somewhat more pronounced irritation has been reported following repeated exposure, presumably due to defatting properties. The UK has advocated (UK EA, 2009) that in the absence of studies on repeated application of LCCPs to skin, a conservative assumption is made that the C18-20 LCCPs could have a similar effect.  

 

There are no specific data on respiratory tract irritation, but on the basis of the low skin and eye irritation potential it is anticipated that the LCCP products are unlikely to cause such an effect. Further, the potential for exposure to the respiratory tract is likely to be minimal given the very low vapour pressure of LCCPs.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification