Registration Dossier

Administrative data

Description of key information

No experimental data available for skin and eye irritation. Further, no prediction could be made using the OECD Toolbox. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Justification for type of information:
No reliable experimental data is available. No prediction for skin irritation could be made using the OECD Toolbox. However, the substance in general is considered as an skin irritant as 131 notifiers out of 225 notifiers in the ECHA CLP data base have classified the substance as skin irrit. 2. For full scientific clarification this would warrant an in vivo testing. As the substance will be classified as a skin sensitizer which indicate a potential for local activity it is considered appropriate to classify the substance as skin irrit.2 without further testing.
Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Justification for type of information:
No reliable experimental data available. No prediction for eye irritation could be made using the OECD Toolbox. However, the substance in general is considered as an eye irritant as 133 notifiers out of 225 notifiers in the ECHA CLP data base have classified the substance as eye irrit. 2. For full scientific clarification this would warrant an in vivo testing. As the substance will have to be classified as an eye irritant it is considered appropriate to classify the substance as eye irrit.2 here without further testing.
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No reliable experimental data available. No prediction for skin and eye irritation could be made using the OECD Toolbox. However, the substance in general is considered as an skin and eye irritant as more than 130 notifiers of a total of 225 notifiers in the ECHA CLP data base have classified the substance as skin and eye irrit. 2. For full scientific clarification this would warrant further in vivo testing for both endpoints. As the substance will be classified as a skin sensitizer which indicate a potential for local activity it is considered appropriate to classify the substance as skin irrit.2 and eye irrit.2 without further testing.

The notifications also contain classifications as an respiratory irritant (STOT SE 3). However, a final conclusion on this endpoint will be taken when the acute inhalation toxicity study has been finalized.


Justification for selection of skin irritation / corrosion endpoint:
No reliable experimental data available. No prediction for skin irritation could be made using the OECD Toolbox. However, the substance in general is considered as an skin irritant as 131 notifiers out of 225 notifiers in the ECHA CLP data base have classified the substance as skin irrit. 2. For full scientific clarification this would warrant an in vivo testing. As the substance will be classified as a skin sensitizer which indicate a potential for local activity it is considerde appropriate to classify the substance as skin irrit.2 without further testing.

Justification for selection of eye irritation endpoint:
No reliable experimental data available. No prediction for skin irritation could be made using the OECD Toolbox. However, the substance in general is considered as an skin irritant as 133 notifiers out of 225 notifiers in the ECHA CLP data base have classified the substance as eye irrit. 2. For full scientific clarification this would warrant an in vivo testing. As the substance will have to be classified as a skin irritant it is considerde appropriate to classify the substance as eye irrit.2 without further testing.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the overall use of classification for skin and eye irritation by the majority of notifiers the classification with Skin irrit. 2; H315 and Eye irrit.2; H319 is maintained.