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EC number: 232-455-8
CAS number: 8042-47-5
A highly refined petroleum mineral oil consisting of a complex combination of hydrocarbons obtained from the intensive treatment of a petroleum fraction with sulfuric acid and oleum, or by hydrogenation, or by a combination of hydrogenation and acid treatment. Additional washing and treating steps may be included in the processing operation. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C50.
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.
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).
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.
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
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
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).
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).
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