Registration Dossier
Registration Dossier
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EC number: 614-114-9 | CAS number: 67746-08-1
Endpoint summary
Administrative data
Description of key information
Skin irritation:
- In vitro Human Skin Model Test (OECD 431, GLP): not corrosive
- In vitro Reconstructed Human Epidermis (RhE) Test Method (OECD draft, GLP): not irritating
Eye irritation:
- In vitro Bovine Corneal Opacity and Permeability (BCOP) test (OECD 437, GLP): not irritating
- In vivo acute eye irritation/corrosion test (OECD 412, GLP): not irritating
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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The in vitro key studies for the endpoint skin irritation indicate that no irritation is to be expected. Additionally, the acute dermal toxicity test indicates that no skin irritation was observed in rats up to a single dose of 2000 mg/kg bw. For eye irritation specifically, in both the in vitro and in vivo test it is concluded that there is no irritation potential by polymerised linseed oil.
Justification for selection of skin irritation / corrosion endpoint:
Two key in vitro skin irritation studies are available for this endpoint, both concluding that there is no dermal irritation to be expected. The Human Skin Model Test was selected as this is an adopted OECD guideline (the RhE test is still a draft OECD guideline).
Justification for selection of eye irritation endpoint:
This study is the in vivo study which is considered of higher toxicological relevance as compared to the in vitro study, although that study indicates the same result.
Justification for classification or non-classification
Based on the available information for skin and eye irritation, polymerised linseed oil does not need to be classified for these endpoints according to the criteria outlined in Annex I of CLP (1272/2008/EC) and Annex VI of DSD (67/548/EEC).
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