Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

No studies on skin irritation have been performed with the substance and none are proposed, based on scientific considerations and for reasons of animal welfare. In accordance with section 8.1, column 2, Annex VII of regulation (EC) 1907/2006), the in-vitro skin irritation study does not need to be conducted as the available information indicates that the criteria are met for classification as corrosive to the skin. In accordance with section 8.1.1, column 2, Annex VIII of regulation (EC) 1907/2006), the in-vivo skin irritation study does not need to be conducted as the substance is a strong acid (pH <2).

Eye irritation

No studies on eye irritation have been performed with the substance and none are proposed, based on scientific considerations and for reasons of animal welfare. In accordance with section 8.2, column 2, Annex VII of regulation (EC) 1907/2006), the in-vitro eye irritation study does not need to be conducted as the available information indicates that the criteria are met for classification as corrosive to the eyes. In accordance with section 8.2.1, column 2, Annex VIII of regulation (EC) 1907/2006), the in-vivo eye irritation study does not need to be conducted as the substance is classified as corrosive to the skin and it is provided that the registrant classified the substance as damaging to eyes, since the substance is a strong acid (pH <2).


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin irritation:
The test substance should be classified as corrosive to the skin by worst case (pH <2). Therefore, the in vivo skin irritation was not conducted due to animal welfare. Hence, the substance has to be classified as skin corrosive 1A substance and labeled with H314: Causes severe skin burns and eye damage.

Eye irritation:

The test substance is classified as corrosive to the skin by default. Therefore, the in vivo eye irritation was not conducted due to animal welfare. Hence, the substance has to be classified as eye damage 1 and labeled with H318: Causes serious eye damage which was already covered by the labeling H314: Causes severe skin burns and eye damage.

Respiratory irritation:

Any classification and labelling according to EUH071: “corrosive to the respiratory tract” is not considered to be applicable in this case, since the substance is only produced, marketed and used in aqueous solution. Additionally, the substance is also only stable in water, the volatility of this substance from aqueous solution is negligible and any exposure to aerosols, particles or droplets of an inhalable size can be ruled out for the intended uses. Therefore, it is not proposed to classify the substance as “corrosive to the respiratory tract”.