Registration Dossier

Administrative data

Description of key information

In accordance with ANNEX VII colum 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5). The experimental pH of the test chemical was 14. Hence, based on the high pH of the test chemical, the in vivo and in vitro sensitization studies were considered for waiver.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH ≤2.0) or base (pH =>11.5)
the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH ≤2.0) or base (pH =>11.5)
the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
Executive summary:

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 hydroxide was 14.Hence this endpoint skin sensitization was considered for waiver.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In accordance with ANNEX VII colum 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5)

The experimental pH of the test chemical was 14. Hence, based on the high pH of the test chemical, the in vivo and in vitro studies were considered for waiver.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) and based on the high pH (pH= 14) of the test chemical, the classification Skin Sensitizer 1 is proposed for the test chemical