Registration Dossier

Administrative data

Description of key information

DERMAL IRRITATION:  Two in vitro dermal irritation / corrosion studies were conducted, one according to OECD Guideline 431.
EYE IRRITATION: Two eye irritation studies were conducted, one in vivo study according to OECD Guideline 405 and EU Method B.5 and one in vitro study.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

DERMAL IRRITATION:

Two GLP compliant in vitro studies were conducted, one (001) according to OECD Guideline 431 (corrosivity) and the other (002) measuring irritation endpoints. The corrosivity study is considered to be reliable (1 according to the Klimisch system) and has been selected as the key study. The other in vitro irritation study is considered to be reliable with restrictions (2 according to the Klimisch system as it is not a guideline study). The studies provide adequate evidence that the substance does not require classification as irritant or corrosive according to the EU DSD and CLP schemes. No in vivo study is considered necessary to further address this endpoint.

EYE IRRITATION

Two eye irritation GLP compliant studies were conducted, one in vivo study (001) according to Guideline 405, which was considered reliable (1 on the Klimisch scale) and one non-guideline in vitro study which applied sound scientific principles (2 on Klimisch scale). Both studies showed that the substance does not warrant classification as an eye irritant according to the EU DSD and CLP schemes.

RESPIRATORY IRRITATION

No specific data on respiratory irritation are available however, no cases of respiratory irritation have been reported by the workers exposed to the substance.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The available study data show that the test material did not produce irritant/corrosive effects to the skin or eye. Hence, there is no requirement to classify the substance as irritant to either skin or eye.