Registration Dossier

Administrative data

Description of key information

Non skin irritant and non eye irritant

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritation of the solid substance was tested on the reconstructed human epidermis according to OECD TG 439 (July 2015). Skin irritation was assessed at 15 min treatment followed by product washing and a post incubation period of 42 h by using the MTT test method to quantify the residual cell viability. Based on adopted prediction model and to MTT results (104.16 %) the test item was classified as not skin irritant according to UN GHS and according to the CLP Regulation (EC n.1272/2008).

 

Eye irritation

The eye irritation of the solid substance was tested on EpiOcularTM Eye Irritation Test (EIT) according to OECD TG 492 (July 2015) specific for solid chemicals. Eye irritation was assessed at 6 h exposure followed by product washing and a post incubation period of 18 h by using the MIT test method to quantify the residual cell viability. Based on the adopted prediction model and to MIT results (66.94 %) the test item was not irritant according to UN GHS and according to the CLP Regulation (EC n.1272/2008).

Justification for classification or non-classification

According to the OECD TG 439 (EPISKIN) the test item is classified not irritant to skin if the mean relative viability is higher than 50 % according to the UN GHS and according to the CLP Regulation (EC n.1272/2008). Based on the result of the in vitro skin irritation test (OECD TG 439: % Viability mean of 3 replicates: 104.16 %) no classification is proposed for test item regarding skin irritation according to the CLP Regulation (EC n.1272/2008).

According to the OECD TG 492 (EIT) the test item is classified not irritant to eye if the mean relative viability is higher than 60 % according to the UN GHS and according to the CLP Regulation (EC n.1272/2008). Based on the result of the in vitro eye irritation test (OECD TG 492: % Viability mean of 2 replicates: 66.94 %) no classification is proposed for test item regarding eye irritation according to the CLP Regulation (EC n.1272/2008).