92/69/EEC A.14 Explosive Properties. SafePharm Laboratories Reactivity Remarks The chemical is not expected to have oxidising properties based on its structure and experience in use. None known any incompatibility with other substances or conditions contributing to instability. The chemical is considered to be stable. are no known hazardous decomposition products. However, the chemical is combustible and will burn if involved in a fire, evolving fumes. 7. TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50>2 000 mg/kg, low toxicity Rat, acute dermal LD50>2 000 mg/kg, low toxicity Rat, acute inhalation No toxicity data were submitted Rabbit, skin irritation Moderately irritating Rabbit, eye irritation Slightly irritating Guinea pig, skin sensitisation adjuvant test Limited evidence of sensitisation. – Rat, repeat dose oral toxicity 28 days. NOAEL = 15 mg/kg/day based on the effects in blood – chemistry, liver and kidney at higher dose levels. Genotoxicity bacterial reverse mutation Non mutagenic – Genotoxicity in vitro Chromosome Aberration Non genotoxic – Genotoxicity in vivo micronucleus test Non genotoxic – Human volunteers, skin irritation Non-irritating in human patch test Guinea pigs, phototoxicity Non-phototoxicity to the skin 7.1. toxicity oral – SUBSTANCE Notified chemical OECD TG 401 Oral Toxicity Limit Test. – EC Directive 84/449/EEC B.1 Acute Toxicity (Oral) Limit Test. – Species/Strain Rat/ Sprague-Dawley Vehicle None. Remarks - Method A range-finding study was performed to establish a dosing regime. No deaths were observed and systemic toxicity noted were hunched posture and lethargy with an additional sign of ataxia. Based on these observations, a dose level of 2000 mg/kg bw was selected for the main study. RESULTS Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/sex 2000 None. LD50 >2000 mg/kg bw Signs of Toxicity Ataxia, hunched posture and lethargy with additional of decreased respiratory rate were seen after dosing. All animals recovered after 24 hours. Effects in Organs None. Remarks - Results None.
92/69/EEC A.14 Explosive Properties. SafePharm Laboratories Reactivity Remarks The chemical is not expected to have oxidising properties based on its structure and experience in use. None known any incompatibility with other substances or conditions contributing to instability. The chemical is considered to be stable. are no known hazardous decomposition products. However, the chemical is combustible and will burn if involved in a fire, evolving fumes. 7. TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50>2 000 mg/kg, low toxicity Rat, acute dermal LD50>2 000 mg/kg, low toxicity Rat, acute inhalation No toxicity data were submitted Rabbit, skin irritation Moderately irritating Rabbit, eye irritation Slightly irritating Guinea pig, skin sensitisation – adjuvant test Limited evidence of sensitisation. Rat, repeat dose oral toxicity – 28 days. NOAEL = 15 mg/kg/day based on the effects in blood chemistry, liver and kidney at higher dose levels. Genotoxicity – bacterial reverse mutation Non mutagenic Genotoxicity – in vitro Chromosome Aberration Non genotoxic Genotoxicity – in vivo micronucleus test Non genotoxic Human volunteers, skin irritation Non-irritating in human patch test Guinea pigs, phototoxicity Non-phototoxicity to the skin 7.1. toxicity – oral Notified chemical OECD TG 401 Oral Toxicity – Limit Test. EC Directive 84/449/EEC B.1 Acute Toxicity (Oral) – Limit Test. Species/Strain Rat/ Sprague-Dawley Vehicle None. Remarks - Method A range-finding study was performed to establish a dosing regime. No deaths were observed and systemic toxicity noted were hunched posture and lethargy with an additional sign of ataxia. Based on these observations, a dose level of 2000 mg/kg bw was selected for the main study. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 2000 None. LD50 >2000 mg/kg bw Signs of Toxicity Ataxia, hunched posture and lethargy with additional of decreased respiratory rate were seen after dosing. All animals recovered after 24 hours. Effects in Organs None. Remarks - Results None. SUBSTANCE RESULTS
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