Registration Dossier

Administrative data

Description of key information

In accordance with ANNEX VII column 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 1.77, which is highly acidic in nature. This is suggestive of the test chemical being highly corrosive and damaging to skin. Hence, the in vivo and in vitro skin 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 (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)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In accordance with ANNEX VII column 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 1.77, which is highly acidic in nature. This is suggestive of the test chemical being highly corrosive and damaging to skin. Hence, the in vivo and in vitro skin sensitization studies were considered for waiver.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The experimental pH of the test chemical was 1.77, which is highly acidic in nature. This is suggestive of the test chemical being highly corrosive and damaging to skin.

According to the CLP Regulation (EC n. 1272/2008) and based on the low pH (pH= 1.77) of the test chemical, the classification Skin Sensitizer 1 is proposed for the test chemical