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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 oils are of low acute toxicity in animal studies conducted by oral (similar to OECD 401), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.
• The oral LD50 was > 5000 mg/kg bw in male and female rats for highly refined base oils.
• The inhalation LC50 was > 5 mg/L (5000 mg/m3) aerosol in male and female rats for highly refined base oils.
• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for highly refined base oils.
In a key acute oral
toxicity study, Sprague-Dawley rats (5/sex) were administered a single
oral gavage dose of 5000 mg/kg of highly refined base oil (Klimisch
score = 2, ARCO, 1987b). After 14 days no mortality was observed. One
of ten animals exhibited loose stools on the day of dosing. No gross
lesions were present at necropsy. All animals exhibited an overall net
weight gain over the study period. The acute oral LD50 of white
mineral oil is greater than 5000 mg/kg body weight and not classified
according to EU guidelines.
In a supporting
study conducted on highly refined base oil (Klimisch score = 2; ARCO,
1987a), rats were administered a single oral gavage dose of 5000 mg/kg
bw. No mortality or other systemic effects were noted at this dose
For acute inhalation
the key study analyzed the effects of white mineral oil on male and
female Crl:CD(SD)BR rats exposed (whole body) to 5 mg/L of aerosolized
highly refined base oil for 4 hours (Klimisch score = 1, ARCO 1988a).
After 14 days no mortality was observed. Clinical signs included
laboured breathing, rates, partial closing of the eyes, nasal
discharge, recumbency, and incoordination. All animals appeared
normal at day 5 after exposure and throughout the remainder of the
study period. Four of five females had transient weight loss during
the first week of observation. The LC50 of highly refined base oil
aerosol administered to rats is greater than 5 mg/L (5000 mg/m3). This
dose level is not classified according to EU guidelines.
In a supporting
study, rats were exposed via inhalation to highly refined base
oil. The LC50 as measured based on mortality and systemic effects was
> 4.5 mg/L aerosol (Klimisch score = 1, ARCO 1988b). In an additional
supporting study, rats were exposed to 5.2 mg/L aerosol of highly
refined base oil (Klimisch score = 1, MB Research Laboratories, Inc.,
1997). Based on mortality and systemic effects, the LC50 was > 5.2
mg/L. These results do not lead to classification of highly refined
base oils as acute inhalation toxicants.
A key study analyzed
the acute dermal toxic effects of highly refined base oil at a dose of
2000 mg/kg under semi-occlusive conditions for 24 hours (Klimisch
score = 2, ARCO, 1987c). After 14 days of exposure no mortality or
treatment-related lesions were observed. Three animals lost weight on
week two and one animal lost weight during the 14-day observation
period. No gross lesions were observed upon necropsy. The acute dermal
toxicity LD50 of highly refined base oil to male and female New
Zealand White Rabbits is greater than 2000 mg/kg and, therefore, is
not classified under EU guidelines.
In a supporting
study, rabbits were dermally exposed to 2000 mg/kg white mineral oil
(Klimisch score = 2, ARCO, 1986). No mortality was noted at this dose
Justification for selection of acute toxicity – oral endpoint
One of two acute oral studies
Justification for selection of acute toxicity – inhalation endpoint
One of three acute inhalation toxicity studies
Justification for selection of acute toxicity – dermal endpoint
One of two acute dermal studies
on evaluation of all the acute toxicity data discussed above, HRBOs do
not meet the criteria for classification as acute oral, inhalation or
dermal toxicants under EU
CLP Regulation (EC No. 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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