Registration Dossier
Registration Dossier
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EC number: 941-237-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In a skin irritation study ammonium chloride (the main constituent of the reaction mass) appeared to be not skin irritating. Based on current information available and the current European classification, the substance is considered to be eye irritating. It is concluded that ammonium chloride should be classified as irritating to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Based on a skin irritation study in rabbits it is concluded that ammonium chloride (the main constituent of the reaction mass) is not a skin irritating substance. All observed effects were reversible within 48 hours.
Based on two old eye irritation studies in rabbits it is concluded that ammonium chloride is an eye irritating substance. In one study after 10 min, 1 and 24hrs, clear signs of inflammation with redness, swelling and cloudy corneal opacity were observed. The changes were reversible within 8 days without leaving any residues. In the second study ammonium chloride caused considerable hypermia of the iriss but by the next day the eyes appeared almost normal. Furthermore, ammonium chloride is officially classified under CLP criteria Eye Irrit. Cat. 4, H319: causes serious eye irritation (Annex VI table 3.1) and Xi, R36 (Annex VI table 3.2).
Effects on eye irritation: irritating
Justification for classification or non-classification
The registered substance has not been tested for the skin and eye irritation/corrosion and, as a result, it is proposed to provide an assessment based on data read-acrossed from its main constituents.
The registered substance is an inorganic reaction mass consisting of water as well as chloride, carbonate and bicarbonate salts of ammonium and sodium. Those salts are well-known substances and relevant peer-reviewed published data are available to characterize their ecotoxicological/environmental fate/toxicological properties.
Two studies pertaining to skin irritation/corrosion effects and two to eye irritation/corrosion effects are available for ammonium chloride. Based on the available peer-reviewed published data, sodium chloride, diammonium carbonate, ammonium hydrogencarbonate and sodium hydrogencarbonate are not irritating for skin and eyes (no classification is needed for these endpoints). As a result, it can be concluded that the reaction mass is not classified for skin and eye irritation/corrosion.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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