TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, oral LD50 2000 mg/kg bw low toxicity Rat, acute oral LD50 >5000 mg/kg bw low toxicity Rat, acute dermal LD50 2000 mg/kg bw low toxicity Rat, acute inhalation not conducted Rabbit, skin irritation slightly irritating Rabbit, eye irritation slightly irritating Guinea pig, skin sensitisation – non-adjuvant test. limited evidence of sensitisation. Rat, repeat dose oral toxicity – 28 days. NOEL <160 mg/kg bw/day Genotoxicity – bacterial reverse mutation non mutagenic Genotoxicity – in vitro chromosomal aberration test non genotoxic toxicity – oral Acute toxicity – oral – Initial Test TEST SUBSTANCE Notified chemical METHOD EC Directive 92/69/EEC B.1 Toxicity (Oral) – Limit Test. Species/Strain Rat/Sprague-Dawley (CD) Vehicle None Remarks - Method No significant protocol deviations. A preliminary study was carried out on a female rat dosed at 500 or 2000 mg/kg bw, and as a result, 2000 mg/kg bw was chosen as the dose level for the main study. RESULTS Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 2000 0/10 LD50 2000 mg/kg bw of Toxicity Piloerection in all animals were observed almost immediately after dosing and was accompanied by hunched posture on Day 1. All animals recovered by Day 4. Effects in Organs Macroscopic examination of all animals at termination kill revealed no abnormalities. Remarks - Results Two male animals had slightly low body weight gain on Day 8 and Day 15. All animals had normal body weight gains through out the study. CONCLUSION The notified chemical is of low toxicity via the oral route. TEST FACILITY Huntingdon Life Sciences Ltd Acute toxicity – oral – Repeat Test TEST SUBSTANCE Notified chemical METHOD OECD TG 401 Acute Oral Toxicity – Limit Test. EC Directive 92/69/EEC B.1 Acute Toxicity (Oral) – Limit Test. Toxic Substances Control Act (TSCA) Health Effects Test Guidelines (40 CFR 798.1175).
There is Low Concern to occupational health and safety under the conditions of the occupational settings described. Public health There is No Significant Concern to public health when used as a fire retardant additive in the manufacture of polyurethane foams. MATERIAL SAFETY DATA Material Safety Data Sheet The MSDS of the notified chemical and products containing the notified chemical provided by the notifier were in accordance with the NOHSC National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC, 2003). The MSDS of the notified chemical is published here as a matter of public record. The accuracy of the information on the MSDS remains the responsibility of the applicant. Label The for the notified chemical and products containing the notified chemical provided by the notifier were in accordance with the NOHSC National Code of Practice for the Labelling of Workplace Substances (NOHSC, 1994). The accuracy of the information on the label remains the responsibility of the applicant. RECOMMENDATIONS REGULATORY CONTROLS Hazard Classification and Labelling The NOHSC Chemicals Standards Sub-committee should consider the following health hazard classification for the notified chemical: R36/38 – Irritating to eyes and skin R43 – May cause sensitisation by skin contact R48/22 – Harmful: danger of serious damage to health by prolonged exposure if swallowed Use the following risk phrases for products/mixtures containing the notified chemical: 20%: R36/38 – Irritating to eyes and skin 1%: R43 – May sensitisation by skin contact 10%: R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed The notified chemical should be classified as follows under the ADG Code: Class 9 – Miscellaneous dangerous goods and articles Packaging Group III CONTROL MEASURES Occupational Health and Safety Employers should implement the following engineering controls to minimise occupational exposure to the notified chemical as introduced: Exhaust ventilation during weighing and transfer of notified chemical into the mixing tank. Enclosed and automated manufacture of polyol and polyurethane foams. Employers should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical as introduced: During transfer operations and cleaning of equipment, avoid spills and splashing.