Registration Dossier

Administrative data

Description of key information

The tests were performed according to the following methods: 
Skin irritation in vitro: draft OECD and EC Test Guidelines andStandard Operating Procedure for EpiDermMTMpublished by ZEBET
Skin corrosion in vitro: Method B.40. Skin corrosion (in vitro),Council Regulation (EC) No.440/2008. Published in O.J. L 142, 2008
Skin irritation/corrosion in vivo: Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008
Eye irritation in vitro: MatTek Ocular Irritation Protocol: Neat Method (MTT ET-50), Rev. 1/1/01 (1)
Eye irritation in vivo: Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008
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

Skin corrosion (in vitro): under the experimental design, the test substance was non corrosive in In vitro Skin Corrosion Test on EpiDermTM tissues.

Skin irritation (in vitro): under the experimental design. average viability of tissues treated by the test substance was 95.1 % of negative control average value (i.e. viability is >50%). According to study results, the test substance was non-irritating in EpiDermTM model.

Acute dermal irritation/corrosion (in vivo): No symptoms of systemic toxicity were observed in the animals during the test period. No skin irritation was caused by 4-hour exposure to test substance. According to study results, the test substance was non-irritating.

Eye irritation in vitro in human corneal model EpiOcularTM: under the design, the test substance was non-irritating for EpiOcularTM tissues.

Eye irritation/corrosion (in vivo): examination of eye irritation after single application demonstrated, that the test substance is slightly irritating for eye of rabbit.

The results of skin irritation/corrosion were negative. Test substance Ashes (residues) – Biomass Combustion may be considered as non-irritating for skin.

The results of eye irritation were evaluated as non-irritating (in vitro) or slightly 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 may be considered as slightly irritating (reversible in six days).


Effects on eye irritation: slightly irritating

Justification for classification or non-classification

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

The results of eye irritation were evaluated as slightly irritating (in vivo) or non-irritating (in vitro). 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 may be considered as slightly irritating (reversible).

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