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Administrative data

Description of key information

- In vitro skin irritation test - a human skin model (EPISKIN Standard Model): not irritating
(OECD Draft Proposal for a New Guideline: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, December 2009, GLP).
- In vitro eye irritation test - Bovine Corneal Opacity and Permeability test (BCOP test): not irritating
(OECD 437, September, 2009, GLP).

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

The key study available for skin irritation was an in vitro skin irritation test using a human skin model (EPISKIN Standard Model). The study procedures were based on the OECD Draft Proposal for a New Guideline: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, December 2009. The relative mean tissue viability obtained after 15 minutes treatment with at least 10 mg of Phosphorous slag compared to the negative control tissues was 86%. Since the mean relative tissue viability for Phosphorous slag was above 50% after 15 minutes treatment Phosphorous slag is considered to be non-irritant.

No supporting studies were available.

 

The key study available for eye irritation was in vitro eye irritation test, the Bovine Corneal Opacity and Permeability test (BCOP test), performed according to OECD Guideline 437. The possible ocular irritancy of Phosphorous slag was tested through topical application for 240 ± 10 minutes. The test substance was applied as a 20% (w/v) suspension (750 ul) directly on top of the fresh isolated bovine corneas. Phosphorous slag did not induce ocular irritation through both tested endpoints, i.e. opacity and permeability, resulting in a mean in vitro irritancy score of 0 after 240 minutes of treatment. It is concluded that Phosphorous slag is a non irritant in this BCOP test.

No supporting studies were available.

 

The respiratory irritation was not studied for Phosphorous slag.

Justification for classification or non-classification

Both in vitro key studies indicate that Phosphorous slag does not induce significant irritation to the skin and eye. Therefore, it can be concluded that the substance is not irritating and therefore does not need to be classified as such according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS) and Annex VI of 67/548/EEC.