Registration Dossier

Administrative data

Description of key information

Oral studies: 1 study in the rat (key study), 1 study in the rabbit, 3 studies in the mouse
Dermal Studies: 1 study in the Rabbit
Other studies: 1 intraperitoneal study in the mouse

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 900 mg/kg bw

Additional information

Oral

The acute oral toxicity of AMP was calculated, based on experimental data, to have an LD50 of 2900 ±140 mg/kg (Power, 1976) for rats. Signs of acute toxicity in the rat included labored breathing, ataxia, and death due to respiratory collapse. There was grossly observable damage noted to the liver, kidney, spleen, and respiratory system, and doses greater than 2800 mg/kg produced irritation to the stomach and duodenum.

Dermal

AMP was evaluated in rabbits via a 24-hour skin patch test, and the LD50 was reported greater than 2000 mg/kg (Parekh, 1980). There were no signs of systemic toxicity, however the treatment sites were necrotic within 2-3 days, and remained so at study termination. Treated groups exhibited a loss in body weight over the 14-day post-treatment period.

Inhalation

There is a low potential for inhalation exposure to AMP based upon typical use patterns and relatively low vapor pressure. There is no available data specifically for acute lethality of inhaled AMP. No guideline studies establishing an LC50 value have been conducted on AMP. Considering the low toxicity via other routes it is probable that AMP would also be of low toxicity via the inhalation route.

Conclusion

AMP is of low toxicity to rabbits by the dermal route (LD50 > 2000 mg/kg). Although the dermal test sites were necrotic within 2-3 days, there were no signs of systemic toxicity noted. Acute oral data in rats supports that AMP is not significantly toxic (LD50 = 2900 mg/kg); signs of acute toxicity noted in the rat were supported by gross pathological observations.

Justification for classification or non-classification

Since the acute toxicity values for AMP are in excess of 2000 mg/kg bw (oral and dermal) AMP does not meet the requirements for classification as Acutely toxic according to either the Dangerous Substances Directive or the GHS classification and labelling criteria.