Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No data.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in chemico
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 classified as skin corrosion (Category 1, 1A, 1B or 1C)
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.3 and sub–section 8.3.1 in chemico/in vitro and/or sub-section 8.3.2 skin sensitisation in vivo, does not need to be conducted since the substance is classified as corrosive to the skin. The substance is classified under Regulation (EC) 1272/2008: Skin Corrosive: category 1A. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3.3, July 2017) the study does not need to be conducted.
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 classified as skin corrosion (Category 1, 1A, 1B or 1C)
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.3 and sub–section 8.3.1 in chemico/in vitro and/or sub-section 8.3.2 skin sensitisation in vivo, does not need to be conducted since the substance is classified as corrosive to the skin. The substance is classified under Regulation (EC) 1272/2008: Skin Corrosive: category 1A. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3.3, July 2017) the study does not need to be conducted.
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 classified as skin corrosion (Category 1, 1A, 1B or 1C)
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.3 and sub–section 8.3.1 in chemico/in vitro and/or sub-section 8.3.2 skin sensitisation in vivo, does not need to be conducted since the substance is classified as corrosive to the skin. The substance is classified under Regulation (EC) 1272/2008: Skin Corrosive: category 1A. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3.3, July 2017) the study does not need to be conducted.
Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.3 and sub–section 8.3.1 in chemico/in vitro and/or sub-section 8.3.2 skin sensitisation in vivo, does not need to be conducted since the substance is classified as corrosive to the skin. The substance is classified under Regulation (EC) 1272/2008: Skin Corrosive: category 1A. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3.3, July 2017) the study does not need to be conducted.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for skin sensitisation.