Registration Dossier

Administrative data

Description of key information

3 Skin irritation studies (one with multiple exposures), 2 Eye irritation studies. All in vivo.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin:

In a study following a protocol similar to the Draize test AMP was tested for irritation using an occluded application to the shaved backs of 6 rabbits (DR-0309-4391-012). The reporting of the study is limited, but under the circumstances of the study AMP was found to be highly irritating, producing clear signs of erythema and odema. There was no information on the recovery period or reversibility of the lesions. In a second study (DR-0309-4391-016) a single rabbit was used to confirm AMP was not corrosive. The test material was applied undiluted to the shaved back of a single rabbit under an occlusive dressing. After 4 hours the patch was removed and the skin was scored for corrosivity. The conclusion of the study was that AMP is not corrosive. The study was terminated at 4 hours and so no details on recovery were reported. Finally, a 5-day repeated dose dermal study was conducted in rabbits (Machle et al., 1940). There are minimal details available in this report and information relating to animal numbers, dose applied, and other key experimental parameters are missing. However the study confirmed that AMP was irritating under the circumstances of the study.

Eyes:

In a study designed to assess the irritancy to eyes, AMP was applied to the eyes of 12 rabbits undiluted. In six of the rabbits, the AMP was washed out 15-30 seconds after dosing. In this study AMP caused serious damage to the eyes and ultimately destroyed the vision (Power, 1975b). The damage was not mitigated even with an immediate flushing of the eyes. The serious occular damage is likely the result of the high pH of the compound instead of any inherent toxicity based on the chemical structure.

Respiratory Tract:

Studies of the potential irritant characteristics of inhaled AMP have been undertaken using the ATSM E981 sensory irritation methodology. Restrained mice were head-only exposed up to 1160 mg/m3 aerosolized AMP for 3 hours followed by a 20 minute recovery period (Detwiler-Okabayashi and Shaper, 1996). No deaths were recorded but sensory and pulmonary irritation of mice was noted


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Based on the above data and in accordance with Annex 1 to the Dangerous substances directive, AMP is classified as Irritating to Skin and Damaging to the eyes. Considering the information on the respiratory irritation it appears that exposure to mists of AMP may cause some respiratory irritation due to the high pH of AMP, however due to the low volatility of AMP and it is not considered appropriate to classify for respiratory inhalation based on the available data.