Registration Dossier

Administrative data

Description of key information

Acute toxicity oral: Study not required because test item is corrosive (Cat. 1B); Regulation (EC) 1907/2006, Annex VII, Part 8.5, Column 2.

Acute toxicity inhalation: Study not required because test item is corrosive (Cat. 1B); test item not available in granular form, Regulation (EC) 1907/2006, Annex VIII, Part 8.5, Part 8.5.2., Column 2.

Acute toxicity dermal: Study not required because test item is corrosive (Cat. 1B); Regulation (EC) 1907/2006, Annex VIII, Part 8.5, Column 2.

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:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
An OECD 431 (EPIDERM) corrosion study was performed on the test item, and the result determined that the test item is corrosive (combination of Cat. 1B and 1C). As per Regulation (EC) 1907/2006, Annex VII, Part 8.5, Column 2:
The study/ies do(es) not generally need to be conducted if: — the substance is classified as corrosive to the skin.
In addition to the above, there is no indication that there is any acute toxicity at concentrations below the corrosivity levels.
Endpoint conclusion
Endpoint conclusion:
no study available

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:
the study does not need to be conducted because the substance is classified as corrosive to the skin
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
An OECD 431 (EPIDERM) corrosion study was performed on the test item, and the result determined that the test item is corrosive (combination of Cat. 1B and 1C). As per Regulation (EC) 1907/2006, Annex VIII, Part 8.5, Column 2:
The study/ies do(es) not generally need to be conducted if: the substance is classified as corrosive to the skin.
In addition to the above, there is no indication that there is any acute toxicity at concentrations below the corrosivity levels.
Furthermore, as per Regulation (EC) 1907/2006, Part 8.5.2., Column 2:
Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.
The registrant confirms that the test item is formulated into a non-granular form prior to import and being placed on the market, therefore there is no liklihood of human exposure to particles of an inhalable size.
Endpoint conclusion
Endpoint conclusion:
no study available

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:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
An OECD 431 (EPIDERM) corrosion study was performed on the test item, and the result determined that the test item is corrosive (combination of Cat. 1B and 1C). As per Regulation (EC) 1907/2006, Annex VIII, Part 8.5, Column 2:
The study/ies do(es) not generally need to be conducted if: the substance is classified as corrosive to the skin.
In addition to the above, there is no indication that there is any acute toxicity at concentrations below the corrosivity levels.
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: oral and dermal

The test item was determined to be corrosive (Cat. 1B) following an OECD 431 (EPIDERM) corrosion study. As per Regulation (EC) 1907/2006, Annex VII, Part 8.5, Column 2:

The study/ies do(es) not generally need to be conducted if the substance is classified as corrosive to the skin.

In addition to the above, there is no indication that there is any acute toxicity at concentrations below the corrosivity levels.

Acute toxicity: inhalation

The test item was determined to be corrosive (Cat. 1B) following an OECD 431 (EPIDERM) corrosion study.

As per Regulation (EC) 1907/2006, Annex VIII, Part 8.5, Column 2:

The study/ies do(es) not generally need to be conducted if: the substance is classified as corrosive to the skin.

In addition to the above, there is no indication that there is any acute toxicity at concentrations below the corrosivity levels.

Furthermore, as per Regulation (EC) 1906/2006, Part 8.5.2., Column 2:

Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.

The registrant confirms that the test item is formulated into a non-granular form prior to import and being placed on the market, therefore there is no liklihood of human exposure to particles of an inhalable size.

Justification for classification or non-classification

Due to the corrosive classification (Cat. 1B) assigned to the substance following an OECD 431 Test, acute toxicity tests (oral / dermal / inhalation) were not performed. However, the unknown potential for acute toxicity of the substance will be considered in hazard communications for products containing the substance.