Registration Dossier

Administrative data

Description of key information

Skin Irritation:

The study need not be conducted because the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5).The experimental pH of tetrabutylammonium hydrogen sulphate was 1.73.Hence this endpoint was considered for waiver.

Eye Irritation:

The study need not be conducted because the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5).The experimental pH of tetrabutylammonium hydrogen sulphate was 1.73.Hence this endpoint was considered for waiver.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin and Eye Irritation:

The study need not be conducted because the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5).The experimental pH of tetrabutylammonium hydrogen sulphate was 1.73.This low value for 1%w/v solution indicates the possibility of lower pH in case of pure substance.

Hence these endpoints were considered for waiver.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) and based on the low pH of tetrabutylammonium hydrogen sulphate, 1% w/v solution (pH= 1.73), the classification H314 (Causes severe skin burns and eye damage) is proposed for tetrabutylammonium hydrogen sulphate.