Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No studies are available on the skin sensitisation effects of the substance. A waiver is proposed for skin sensitisation in accordance with Column 2 of Annexes VII, No. 8.3 on the basis that the substance is classified as corrosive. The local dermal effects of anhydrous ammonia will be dominated by irritation/corrosion and sensitisation is considered to be unlikely. Additional testing is not required and is considered to be unjustified both scientifically and on animal welfare grounds.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no studies available on the skin sensitisation effects of the substance.

 

Ammonia (anhydrous and aqueous solutions ) is corrosive to the skin: reports of skin damage in humans following exposure are numerous. According to Part 3 of Annex VI of the CLP Regulation 1272/2008/EC, anhydrous ammonia has a harmonised classification for corrosive effects. It is classified for corrosivity as: Category 1B, H314 “Causes severe skin burns and eye damage” according to Annex VI of the CLP Regulation 1272/2008/EC. A waiver is proposed in accordance with Annex VII No. 8.3 Column 2 of the REACH Regulation on the basis that the substance is classified as corrosive to the skin. Additional testing for skin sensitisation is not required and is considered to be unjustified both scientifically and on animal welfare grounds. There have been no reports of skin sensitisation (i.e. delayed contact hypersensitivity) resulting from human exposure to the substance; effects are likely to be dominated by local, site of contact effects (e.g. irritation and corrosion).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no data available on the respiratory sensitisation effects of the substance. There are currently no validated test methods for this endpoint. There have been no reports of respiratory sensitisation (e.g. occupational asthma) resulting from human exposure to the substance. The primary hazard posed by the substance to the skin and the respiratory tract is expected to be mediated by local, site of contact effects due to its corrosive properties. Ammonia is exhaled in small quantities as a consequence of its presence in the blood from protein catabolism.

Justification for classification or non-classification

There is no evidence that ammonia causes skin or respiratory tract sensitisation; effects will be mediated locally, due to the corrosive/irritant properties of the substance. The substance does not have a harmonised classification for sensitisation effects. No classification is proposed.