OSHA comments from the January 19, 1989 Final Rule on Air Contaminants Project extracted from 54FR2332 et. seq. This rule was remanded by the U.S. Circuit Court of Appeals and the limits are not currently in force.
CAS: 111-30-8; Chemical Formula: OCH(CH2)3CHO
OSHA previously had no limit for glutaraldehyde and proposed establishing a ceiling limit of 0.2 ppm, based on the ACGIH (1986/Ex. 1-3) recommendation. NIOSH (Ex. 8-47, Table N1) concurred with this proposal, and the final rule establishes this limit. Glutaraldehyde is an aliphatic dialdehyde that forms colorless crystals.
Glutaraldehyde is strongly irritating to the nose, eyes, and skin (Human Sensory Irritation Threshold of Glutaraldehyde Vapor 1976, as cited in ACGIH 1986/Ex. 1-3, p. 285) and can cause allergic contact dermatitis from occasional or incidental occupational exposure (Jordan, Dahl, and Albert 1972/ Ex. 1-1056). The rat oral LD(50) has been variously reported as 250, 820, and 2380 mg/kg (Stonehill, Krop, and Borick 1963/Ex. 1-1066; Smyth 1963 and NIOSH 1975f, both as cited in ACGIH 1986/Ex. 1-3, p. 285). The dermal LC(50) in the rabbit is 2560 mg/kg, and the 4-hour inhalation LD(50) in the rat is 5000 ppm (NIOSH 1975f, as cited in ACGIH 1986/Ex. 1-3, p. 285).
Mice exposed to alkalinized glutaraldehyde at 8 and 33 ppm for 24 hours have shown marked nervous behavior with panting and compulsive washing of the face and limbs; those exposed to 33 ppm exhibited signs of toxic hepatitis at autopsy (Varpela, Otterstrom, and Hackman 1971/Ex. 1-1072).
In a study of a cold-sterilizing operation in which the operator was exposed for 12 minutes to an activated 2-percent aqueous solution, a measurement of 0.38 ppm glutaraldehyde was taken in the operator's breathing zone; the operator and the investigators experienced severe eye, nose, and throat irritation as well as sudden headache at the end of this procedure (Schneider and Blejer 1973, as cited in ACGIH 1986/Ex. 1-3, p. 285). Another study employing very precise methods of airborne concentration measurement reported the irritation response level for glutaraldehyde to be 0.3 ppm and the odor recognition threshold to be 0.04 ppm (Colwell 1976, as cited in ACGIH 1986/Ex. 1-3, p. 285).
Other than the NIOSH submission, OSHA received no comments on its proposal to establish a ceiling level of 0.2 ppm for glutaraldehyde. The Agency finds that the human evidence cited above clearly demonstrates a significant risk of irritation to the eyes, nose, and throat associated with short-term exposures to glutaraldehyde at concentrations of 0.3 ppm or above. OSHA consides the irritation effects associated with exposure to glutaraldehyde to be material impairments of health. Therefore, OSHA is establishing a 0.2-ppm ceiling limit for this substance in the final rule.
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