Registration Dossier

Administrative data

Description of key information

Test substance Dust, steelmaking was assayed for the in vitro skin corrosion in human epidermal model EpiDerm. The test was performed according to Method B. 40. Skin corrosion (in vitro). Under the above-described experimental design, the test substance Dust, steelmaking was non corrosive in In vitro Skin Corrosion Test on EpiDerm tissues.
Test substance Dust, steelmaking was assayed for the in vitro skin irritation in human epidermal model EpiDerm. The test was performed according to draft OECD and EC Test Guidelines and Standard Operating Procedure for EpiDerm published by ZEBET. According to study results, the test substance was non-irritating in EpiDerm model.
The test substance, Dust, steelmaking, was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test. Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion. No symptoms of systemic toxicity were observed in the animals during the test period. No skin irritation was caused by 4-hour exposure to Dust, steelmaking. According to study results, the test substance was non-irritating.
Test substance Dust, steelmaking was assayed for the in vitro eye irritation in human corneal model EpiOcular. The test was performed according to MatTekOcular Irritation Protocol: Neat Method (MTT ET-50), Rev. 1/1/01 (1). Under the above-described experimental design, the test substance Dust, steelmaking was moderately irritating for EpiOcular tissues.
The test substance, Dust, steelmaking, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed). The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. According to study results, the test substance was irritating (reversible).
All the tests mentioned above were performed in accordance with 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:
adverse effect observed (irritating)

Additional information

The results of skin irritation/corrosion were negative. Test substance Dust, steelmaking may be considered as non-irritating for skin.

The results of eye irritation were evaluated as moderately irritating (in vitro) or irritating (in vivo). Since the in vitro model (EpiOcular) have not been fully validated yet, there is preferable to consider in vivo results to be more reliable. Therefore, the test substance Dust, steelmaking may be considered as irritating (reversible).


Effects on eye irritation: irritating

Justification for classification or non-classification

The results of skin irritation/corrosion were negative. Test substance Dust, steelmaking may be considered as non-irritating for skin.

The results of eye irritation were evaluated as moderately irritating (in vitro) or irritating (in vivo). Since the in vitro model (EpiOcular) have not been fully validated yet, there is preferable to consider in vivo results to be more reliable. Therefore, the test substance Dust, steelmaking may be considered as irritating (reversible).

Due to classification according to Directive 67/548/EEC, Annex VI, the test substance does not have to be classified for skin irritation.