Registration Dossier
Registration Dossier
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EC number: 910-388-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
No skin irritation potential was observed. Furthermore, corrosive or a severe irritating potential to the eye were excluded by in-vitro testing.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The skin irritation potential of Silica-Zirkonia Filler was tested in-vitro according to OECD Guideline 431 and OECD Draft Proposal "In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method".
Skin corrosion ability was tested on a human three dimensional epidermal model (EpiDerm (EPI-200)), with 25 mg test material applied directly on top of the skin tissue. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test substance was not below 50% and 15%, respectively, the test material was not considered to be corrosive.
The skin irritation potential was tested on a human three dimensional epidermis model (EPISKIN-SM TM), with 10 mg test material applied directly on top of the skin tissue (0.38 cm2). A 15 min exposure to the test substance resulted in a 113% viability of treated skin tissue as compared to negative control treatment. Thus, the test material was considered to be non-irritant to human skin in vitro.
The eye corrosion or severe irritation potential of Silica-Zirkonia Filler was tested in-vitro according to OECD Guideline 437.
750 µL of a 20% suspension of the test material were introduced onto the epithelium of the cornea of a bovine eye and uniformously distributed over the entire cornea. The treated corneas showed opacity values ranging from 1 to 3 and permeability values ranging from 0 to 0.009, but were clear after the 240 minutes exposure. Hence, the in-vitro irritancy scores ranged from 1 to 3 after 240 minutes of treatment. According to the guideline the test substance can be regarded as neither corrosive nor severely irritating to the eye.
Justification for classification or non-classification
No classification for skin irritation is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC), respectively. Classification for eye irritation cannot be undertaken since only corrosion or a severe irritating potential were excluded.
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