The notified chemical was found to be at least, severely irritating to the eye in rabbits. Considering the progress of the corneal opacity observed during the study, the damage to the cornea might not be reversible. This may indicate that PF-310 has corrosive potential to the rabbit eye. The chemical was a slight skin irritant in rabbits and showed mild skin sensitisation in guinea pigs at low levels of induction. In a 28-day repeated oral dose study in rats, administration of the notified chemical at a dose level of 1 000 mg.kg-1.day-1 was associated with low body weight, reduced food consumption, swollen appearance of the abdominal area, rales, laboured breathing and excessive salivation. There were no significant haematological changes. The target organ for toxicity was the gastro-intestinal tract. The notified chemical was found not to be mutagenic by bacterial reverse mutation assay or genotoxic by chromosomal aberration assay in cultured human lymphocytes in vitro. No in vivo studies were performed. The notified chemical would be classified as hazardous according to National Occupational Health and Safety Commission’s Approved Criteria for Classifying Hazardous Substances (Approved Criteria) in relation to serious eye effects but not in relation to the other toxicological data supplied. However, as the notified chemical will be imported as a minor ingredient (less than 1%) of photocopier products (which are not hazardous according to the Approved Criteria), photocopier toners and developers would not be classified as hazardous. ASSESSMENT OF ENVIRONMENTAL EFFECTS Ecotoxicological data are not required for chemicals with import volumes less than one tonne per year according to the Act. However, the notifier supplied the following studies, summarised below. The studies were carried out to OECD and to U.S. EPA Guidelines.
The notified chemical was found to be at least, severely irritating to the eye in rabbits. Considering the progress of the corneal opacity observed during the study, the damage to the cornea might not be reversible. This may indicate that PF-310 has corrosive potential to the rabbit eye. The chemical was a slight skin irritant in rabbits and showed mild skin sensitisation in guinea pigs at low levels of induction. In a 28-day repeated oral dose study in rats, administration of the notified chemical at a dose level of 1 000 mg.kg-1.day-1 was associated with low body weight, reduced food consumption, swollen appearance of the abdominal area, rales, laboured breathing and excessive salivation. There were no significant haematological changes. The target organ for toxicity was the gastro-intestinal tract. The notified chemical was found not to be mutagenic by bacterial reverse mutation assay or genotoxic by chromosomal aberration assay in cultured human lymphocytes in vitro. No in vivo studies were performed. The notified chemical would be classified as hazardous according to National Occupational Health and Safety Commission’s Approved Criteria for Classifying Hazardous Substances (Approved Criteria) in relation to serious eye effects but not in relation to the other toxicological data supplied. However, as the notified chemical will be imported as a minor ingredient (less than 1%) of photocopier products (which are not hazardous according to the Approved Criteria), photocopier toners and developers would not be classified as hazardous. ASSESSMENT OF ENVIRONMENTAL EFFECTS Ecotoxicological data are not required for chemicals with import volumes less than one tonne per year according to the Act. However, the notifier supplied the following studies, summarised below. The studies were carried out to OECD and to U.S. EPA Guidelines.