Registration Dossier

Administrative data

Description of key information

Additin E459 proved to be corrosive in an in-vitro skin irritation/Corrosion study and is allocated to the respective category of corrosive substances.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN IRRITATION / CORROSION

In an in-vitro study for predicting non-specific, corrosive potential of Additin E 459 by using reconstructed human skin (RHS) EST-1000 was performed in accordance with OECD TG 431 and with EC guideline (amending Concil Direcrive 67/548/EEC B 40 Skin corrosion). Additin E 459 was tested undiluted (25 mg per insert, plus 50 µl 0.9 % NaCl to moisten and to ensure good contact with the skin). An incubation time of 3 min or of 60 min was used to determine time related toxic effects. After incubation the MTT reduction assay was performed to measure the cell viability which was 47 % and 37 % , respectively. Thus, the results show that a corrosive property of the test item was determined by the assay used (Vohr 2013)

EYE IRRITATION

There is no in-vitro eye irritation study available. According to the specific rules in Column 2 of ANNEX VII of Regulation (EC) No. 1907/2006 (REACh) a study does not need to be conducted because the available information indicates that the critera are met for the classification as corrosive to the skin. Hence, the substance is classified as corrosive by the producer.


Justification for selection of skin irritation / corrosion endpoint:
The available in vitro study is performed according to the respective guidline under GLP conditions and evaluated with Klimisch score 1. The substance was shown to have corrosive properties.

Justification for selection of eye irritation endpoint:
Additin E 459 was shown to have corrosive properties to the skin and is classified/labelled accordingly. Therefore no study needs to be conducted.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Based on the available study results Additin E 459 is classified as corrosive (R35 = causes severe burns) according to Directive 67/548/EWG.

With respect to Regulation (EC) 1272/2008 Additin E 459 is allocated to the category of corrosive substances. Referring to the revised OECD TG 431 in July 2013, which provides now clear definitions for the evaluating of corrosive substances, Additin E 459 has to be allocated to Category 1A (H314) of corrosive substances.