Registration Dossier

Administrative data

Description of key information

In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in chemico or in vitro / ex vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin irritation / skin corrosion study performed in 1981 are available, indicating that the substance should be classified as skin corrosion (Category 1, 1A, 1B or 1C) (carried out before 11 October 2016). The study is therefore scientifically not necessary, as other information is available.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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) 1907/2006 as amended: Annex VII, section 8.3: the in chemico or in vitro / ex vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin irritation / skin corrosion study performed in 1981 are available, indicating that the substance should be classified as skin corrosion (Category 1, 1A, 1B or 1C) (carried out before 11 October 2016). The study is therefore scientifically not necessary, as other information is available.
Reason / purpose:
data waiving: supporting information

Conclusions:
An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin irritation / skin corrosion study performed in 1981 are available, indicating that the substance should be classified as skin corrosion (Category 1, 1A, 1B or 1C) (carried out before 11 October 2016). The study is therefore scientifically not necessary, as other information is available.
Executive summary:

In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in chemico or in vitro / ex vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin irritation / skin corrosion study performed in 1981 are available, indicating that the substance should be classified as skin corrosion (Category 1, 1A, 1B or 1C) (carried out before 11 October 2016). The study is therefore scientifically not necessary, as other information is available.

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in chemico or in vitro / ex vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin irritation / skin corrosion study performed in 1981 are available, indicating that the substance should be classified as skin corrosion (Category 1, 1A, 1B or 1C) (carried out before 11 October 2016). The study is therefore scientifically not necessary, as other information is available.

Justification for classification or non-classification

In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in chemico or in vitro / ex vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin irritation / skin corrosion study performed in 1981 are available, indicating that the substance should be classified as skin corrosion (Category 1, 1A, 1B or 1C) (carried out before 11 October 2016). The study is therefore scientifically not necessary, as other information is available.