MINERAL OIL (medium- and low-viscosity, Class II)

Comments:

The Committee concluded that the newly submitted data did not adequately address its previous requests for information on the relevance to humans of the response of F344 and Sprague-Dawley rats to mineral oil (medium and low viscosity) classes II and III. The studies were conducted with a single administration, and it was not possible to predict the concentration in the target organ (liver) at steady state, or the potential for accumulation, in humans. Information requested at the forty-fourth meeting on compositional factors of mineral oils that influence absorption and toxicity had not been provided for materials meeting the criteria of mineral oil (medium and low viscosity) classes II and III. The Committee noted that hydrocarbon deposits with carbon numbers consistent with mineral oils, including those of classes II and III, and associated lesions have been reported in human tissues, demonstrating the potential relevance to humans of the effects in the F344 rat. Because all blood levels were below the limit of detection in the single-dose human toxicokinetic study, it was not possible to reach conclusions on the rate of elimination of mineral oils in humans or on the concentration in the liver at steady state following prolonged exposure. Therefore, the new data did not provide information that would allow an ADI to be established based on internal exposure. Similarly, it was not possible to establish an ADI based on external dose in the absence of information on the relative accumulation potential of classes II and III mineral oils in humans compared with rats. The Committee noted that the temporary group ADI for mineral oil (medium and low viscosity) classes II and III had been established in 1995 and extended on a number of occasions. As data supporting the establishment of a full ADI had not been made available, the previously established temporary group ADI was withdrawn.

Specs Code:

W

Report: 

Specification: 

Comments:

Extension of the temporary group ADI

Report: 

Tox Monograph: 

ADI:

0-0.01 mg/kg bw (1995)

Comments:

Temporary group ADI of 0-0.01 mg/kg bw for class II oils, including N70(H) and N70(A), and class III oils, including P15(H), N15(H), and N10(A), extended to 2011

Meeting:

44

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

Previous Years: