Registration Dossier

Administrative data

Description of key information

Waivers are appropriate for acute oral, dermal and inhalation toxicity as sodium hydrogen difluoride is a corrosive substance and additionally is already classified as Toxic if swallowed (H301) under CLP.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Test material information:
Composition 1
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
No study is available: a waiver is proposed.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
No study is available: a waiver is proposed.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Test material information:
Composition 1
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
No study is available: a waiver is proposed.

Additional information

Acute oral toxicity

No data are available. A waiver is appropriate for this endpoint in accordance with Column 2 of REACH Annex VII as the substance is corrosive. It is noted that sodium hydrogen difluoride is classified for acute toxicity under CLP.

Acute inhalation toxicity

No data are available. A waiver is appropriate for this endpoint in accordance with Column 2 of REACH Annex VIII as the substance is corrosive.

Acute dermal toxicity

No data are available. A waiver is appropriate for this endpoint in accordance with Column 2 of REACH Annex VIII as the substance is corrosive.


Justification for selection of acute toxicity – oral endpoint
A waiver is proposed in accordance with Column 2 of the Annex VII REACH data requirements (specific rules for adaptation from Column 1). A study does not need to be conducted because sodium hydrogen difluoride is classified as Corrosive and additionally is already classified as Toxic if swallowed (H301) under CLP.

Justification for selection of acute toxicity – inhalation endpoint
A waiver is proposed in accordance with Column 2 of the Annex VIII REACH data requirements (specific rules for adaptation from Column 1). A study does not need to be conducted because sodium hydrogen difluoride is classified as Corrosive.

Justification for selection of acute toxicity – dermal endpoint
A waiver is proposed in accordance with Column 2 of the Annex VIII REACH data requirements (specific rules for adaptation from Column 1). A study does not need to be conducted because sodium hydrogen difluoride is classified as Corrosive.

Justification for classification or non-classification

Sodium hydrogen difluoride is classified according to the CLP Regulation (EC) 1272/2008 in Acute Toxicity Category 3 (H301). No change is proposed to the existing classification.