Registration Dossier

Administrative data

Description of key information

An in vitro skin corrosion (OECD TG 431) and in vitro skin irritation study B46 have been performed. Kieselguhr soda ash flux calcined is not irritating to skin. An in vitro eye irritation study using RHC tissue and an in vivo eye irritation study (OECD TG 405 ). Kieselguhr soda ash flux calcined is not irritating to eyes. 

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

Skin irritation:

An in vitro skin corrosion study and in vitro skin irritation study using using the EpiskinTM reconstituted human epidermis model have been performed (Warren 2010). In the in vitro skin corrosion study duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes. The test material was considered to be non-corrosive. In the skin irritation study triplicate tissues were treated with the test material for an exposure period of 15 minutes. The relative mean viability of the test material treated tissues was 102.6% after a 15 minute exposure and was therefore not considered to be a skin irritant.

Eye irritation (in vitro):

An in vitro eye irritation study has been performed (Warren 2010) using the SkinEthic Reconstituted Human Corneal model after a treatment period of 10 minutes.Cytotoxicity was determined by the reduction of MTT to formazan by viable cells in the test material treated tissues (quantitative measurement of tissue viability) relative to the negative control. The test material was classified according to the following criteria:i) If the percentage relative mean tissue viability ≥ 60% the test material was considered to be non-irritant (NI). ii) If the percentage relative mean tissue viability was <60% the test material was considered to be an irritant (I). The relative mean viability of Kieselguhr soda-ash flux calcined after a 10 minute exposure was 99.1% and it was therefore considered not to be an eye irritant.

Eye irritation (in vivo):

An in vivo eye irritation study was performed according to OECD Guideline 205. A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. Both treated eyes appeared normal after the 72 h observation. The test material was not considered to be irritating to eyes in accordance with CLP criteria.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin irritation/corrosion:

An in vitro skin corrosion and irritation study have been performed which confirm that the substance is not corrosive or irritating to skin. The in vitro method using the EpiSkinTM test method is considered for the classification of substances for skin irritancy according to CLP criteria (ECVAM/ESAC, 2009). No classification for skin irritancy is required.

Eye irritation:

The test substance was not irritating to the eyes of rabbits. No classification for eye irritation is required.