Registration Dossier

Administrative data

Description of key information

An in vitro skin corrosion study was performed for 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) in line with OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method). The test was compliant with GLP. 2-Ethylhexanoic acid, compound with 2-aminoethanol (1:1) was applied neat at 50µl to reconstructed human epidermal model Epiderm™. A negative (sterile water) and positive control (potassium hydroxide) was prepared and run in parallel. Exposure was permitted for a 3- and 60-minute period at 37 °C, 5 % CO2, 95 % RH. Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are then used to make a prediction of the corrosivity potential of the test item.

All controls were valid and demonstrated the reliability of the test system. Mean tissue viability, calculated as a percentage of the negative control, was 8.6 % after a 60-minute exposure and 97.6 % after a 3-minute exposure. A classification for skin corrosion (Skin Corr. 1B/1C) is subsequently required for 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) according to CLP Regulation (EC) No. 1272/2008.

Therefore, 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) was classified as corrosive to skin (Skin Corr. 1B/1C) following a mean tissue viability of 97.6 and 8.6 % after a 3- and 60-minute exposure period, respectively (CLP Regulation (EC) No. 1272/2008). In accordance with Annex VII of REACH, Column 2, as 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) is classified as corrosive to the skin, the eye irritation and skin irritation studies do not need to be conducted.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VII of REACH, Column 2, it is not needed to conduct an in vitro skin irritation since results from the in vitro skin corrosion study performed on the registered substance already allow a conclusive decision on the classification.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

2-Ethylhexanoic acid, compound with 2-aminoethanol (1:1) is classified as Skin Corr 1B/1C; H314. In accordance with Annex VII of REACH, a substance being classified as corrosive to the skin shall be classified as Eye Dam 1; H318. Studies for eye irritation and skin irritation therefore do not need to be conducted and no classification is to be derived regarding eye and skin irritation for 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1).