Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Four irritation studies were carried out on the test material H-MI ammonium salt, two in relation to skin irritation and two concerned with eye irritation.
All studies have been ranked 'reliability 1' according to the Klimisch et al scale as they were conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
In both cases an in vitro study was carried out prior to an in vivo study. As in vivo studies are considered to provide a more accurate basis for classification the in vivo studies were designated as the key studies.
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:
- no adverse effect observed (not irritating)
Additional information
Skin Irritation: Both the in vitro study ( Determination of skin irritation potential using the EPISKIN (TM) Reconstituted Human Epidermis Model) and the in vivo study (OECD Guideline 404 (Acute Dermal Irritation / Corrosion)) showed no effects to exposure to H-MI ammonium salt and as a result it was concluded that the test material was non irritating to the skin.
Eye Irritation: Both the in vitro study (SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, Nice, France)) and the in vivo study (OECD Guideline 405 (Acute Eye Irritation / Corrosion)) showed no effects to H-MI ammonium salt and as a result it was concluded that the test material was non irritating to eyes.
Justification for classification or non-classification
Skin Irritation: No effects to the skin were noted either during the in vitro or in vivo study indicating that the test material can be considered to be non classified in relation to skin irritation.
Eye irritation: No effects to the eye were noted either during the in vitro or in vivo study indicating that the test material can be considered to be non classified in relation to eye irritation.
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