Registration Dossier
Registration Dossier
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EC number: 941-237-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a skin sensitisation test with guinea pigs (maximalisation test), ammonium chloride (the main constituent of the reaction mass) appeated to be non skin sensitising. The treated animals did not show any signs of toxicity throughout the study period. During induction: Very slight to slight edema were observed in the treatment group. During challenge: 24 and 48 hours after removal of the occlusive dressing, a total of 2 animals (in 20) of the treatment group showed very slight, hardly perceptible erythema. Ten percent of the animals of treatment group demonstrated a positive reaction after the challenge exposure (the criteria: the limit value of 30 percent).
Migrated from Short description of key information:
In a skin sensitisation study with guinea pigs, ammonium chloride (the main constituent of the reaction mass) appeared to be not skin sensitising.
Justification for classification or non-classification
The registered substance has not been tested for the skin sensitization, 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.
One study pertaining to skin sensitization is available for ammonium chloride. Based on the available peer-reviewed published data, sodium chloride, diammonium carbonate, ammonium hydrogencarbonate and sodium hydrogencarbonate are not a skin sensitizer (no classification is needed for this endpoint). As a result, it can be concluded that the reaction mass is not classified for skin sensitization.
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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