Registration Dossier

Administrative data

Description of key information

No studies of skin or eye irritation are available; waivers are proposed as the subsatnce is considered to be corrosive based on its low pH.

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

No studies of skin or eye irritation are available. The pH of an aqueous solution of MK92K was measured to be 1.2 (Leslie & Moseley, 2010).

Skin irritation

 

According to Annex XI of the REACH Regulation, a study of skin irritation does not need to be performed if the substance is a strong acid or base (pH value of <2 or >11.5). A waiver is therefore proposed for this endpoint for MK92K as the pH of the substance is such that corrosivity is assumed. Testing for skin irritation according to the requirements of Annexes VII and VIII of the REACH Regulation is not scientifically justified and cannot be supported on animal welfare grounds.

 

Eye irritation

According to Annex XI of the REACH Regulation, a study of eye irritation does not need to be performed if the substance is a strong acid or base (pH value of <2 or >11.5). A waiver is therefore proposed for this endpoint for MK92K as the pH of the substance is such that corrosivity is assumed. Testing for eye irritation according to the requirements of Annexes VII and VIII of the REACH Regulation is not scientifically justified and cannot be supported on animal welfare grounds.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

It is proposed that the substance is classified according the Dangerous Substances Directive (67/548/EEC) as Corrosive (R34) ‘Causes burns’ and according to the CLP Regulation (1272/2008) as Corrosive (Skin Corr. 1B) with the hazard statement (H314) Causes severe skin burns and eye damage. This classification is proposed in the absence of specific data, but based on the low pH of the substance. The use of the additional risk phrase (R41) ‘Risk of serious damage to eyes’ is implicit under the Dangerous Substances Directive and is not required.