Registration Dossier

Administrative data

Description of key information

No studies of the acute toxicity of MK92K are available. Waivers are proposed in accordance with Column 2 of Annexes VII and VIII of the REACH Regulation as the substance is corrosive.

Key value for chemical safety assessment

Additional information

The substance MK92K is classified as corrosive based on the basis of pH measurements. Testing for acute toxicity has therefore been waived for scientific reasons and additionally cannot be justified on animal welfare grounds. The likely poor systemic absorption of the substance (predicted from its physicochemical properties and by read-across from other quaternary ammonium compounds) indicates that the effects of MK92K will be predominantly or entirely local (i.e. at the site of contact).

 

Acute oral toxicity

 

No study of the acute oral toxicity of MK92K is available. A waiver is proposed for this endpoint in accordance with Column 2 of Annex VII of the REACH Regulation as the substance is corrosive.

 

Acute dermal toxicity

 

No study of the acute dermal toxicity of MK92K is available. A waiver is proposed for this endpoint in accordance with Column 2 of Annex VIII of the REACH Regulation as the substance is corrosive. Although dermal exposure is a potentially relevant route of occupational exposure, the corrosive nature of the substance means that appropriate personal protective equipment (PPE) including gloves, face mask and overalls must be used by workers. Dermal exposure under the normal conditions of use of MK92K is therefore not predicted. The physicochemical properties of the substance are such that, even if dermal exposure were to occur, systemic absorption is considered unlikely and the effects of exposure would local (i.e. at the site of contact only).

 

Acute inhalation toxicity

 

No study of the acute inhalation toxicity of MK92K is available. A waiver is proposed for this endpoint in accordance with Column 2 of Annex VIII of the REACH Regulation as the substance is corrosive. Although inhalation exposure is a potentially relevant route of occupational exposure, the substance is a non-volatile liquid and is not used in a way which is likely to generate inhalable particles. Inhalation exposure under the normal conditions of use of MK92K is therefore not predicted. The physicochemical properties of the substance are such that, even if inhalation exposure were to occur, systemic absorption is considered likely to be low and the effects of exposure would local (i.e. at the site of contact only).

Justification for classification or non-classification

No acute toxicity data are available. The effects of acute exposure to the substance will be dominated by local irritation/corrosion at the site of contact and significant systemic toxicity is not predicted due to the likely poor absorption of the substance. Testing for acute toxicity is not justified on scientific grounds or for reasons of animal welfare. No classification for acute toxicity is therefore proposed according to the Dangerous Substance Directive (67/548/EEC) or the CLP Regulation 1272/2008.