Registration Dossier

Administrative data

Description of key information

Skin Irritation

Highly refined base oil was found to be non-irritating to rabbit skin over a 24 to 72 hour period with a 24 hour exposure period (similar to OECD 404).  Erythema and edema scores were 0.0 for all sites.

Eye Irritation

Highly refined base oil was found to be non-irritating to rabbit eyes when exposed to 0.1 mL of undiluted mineral oil (OECD 405).  The mean unwashed conjunctivae score (24-72 hours) was 0.22 while the mean cornea and iris score was 0 (24-72 hours).

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 Irritation

The key dermal irritation study (Klimisch score = 1, ARCO, 1987d) tested a sample of highly refined base oil on male white rabbits. The animals were exposed to 0.5 mL of undiluted white mineral oil at two abraded and two unabraded test sites for 24 hours. After exposure, the skin irritation was scored (Draize technique) for erythema and edema responses at 24 and 72 hours post-application. Mean erythema and edema scores were 0.0 for all sites. Based on these findings, highly refined base oil is considered a non-irritating substance.

 

In an additional supporting study (Klimisch score = 1, ARCO, 1987e), rabbits were dermally exposed to highly refined base oil for 24 hours and observed for irritation. The study did not result in irritation according to the mean erythema or edema scores. 

 

Eye Irritation

A key eye irritation study (Klimisch score = 1, ARCO, 1987f) analyzed the effects of highly refined base oil on male New Zealand White rabbits. A very mild irritation occurred in one rabbit in the unrinsed group at 24 hours, but was completely reversible by 48 hours. A second rabbit in the unrinsed group exhibited a very mild irritation at 48 hours, but was completely reversible by 72 hours. Under the conditions of this study, the mean unwashed cornea and iris scores (24-72 hours) were both 0.0. The mean unwashed conjunctivae score (24-72 hours) was 0.22. The test material is considered not irritating to the eye.

 

In an additional eye irritation supporting study (Klimisch score = 1, ARCO 1987g), rabbits were exposed to highly refined base oil and observed for irritation. The study did not result in irritation according to the mean cornea, iris or conjunctivae scores. 

 

Justification for selection of skin irritation / corrosion endpoint:

One of two skin irritation studies

Justification for selection of eye irritation endpoint:

One of two eye irritation studies

Justification for classification or non-classification

Based on skin irritation scores of 0.0 for both erythema and edema, after 24 hours exposure, highly refined based oils do not meet the criteria for classification as a skin irritant as defined by the EU CLP Regulation (EC No. 1272/2008).

Based on a lack of corneal and iridial irritation, and a conjunctival irritation score of 0.22/20, HRBOs do not meet the criteria for classification as an eye irritant as defined by the EU CLP Regulation (EC No. 1272/2008).