Phosphoric acid, decyl octyl ester

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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 corrosive to the skin

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Based on the in vitro study results, the test substance, mono- and di- C8-10 PSE was determined to be corrosive to the skin and eyes.

Endpoint conclusion:

adverse effect observed (corrosive)

Endpoint conclusion:

adverse effect observed (irreversible damage)

Endpoint conclusion:

no study available

Study 1: An in vitro study was conducted to determine the skin irritation potential of the test substance, mono- and di- C8-10 PSE (100%) usingReconstructed Human Epidermis Test Method,according to OECD 439 Guideline, in compliance with GLP. Three tissues of the human skin model EpiDermTM were treated with the test substance, positive or negative control for 60 minutes (25 minutes at room temperature and 35 minutes at 37 °C, 5 % CO2, 95 % RH) and 42 h post incubation period. Tissues were exposed to 30 µL of the neat test substance by topical application. 30 μL of DPBS was used as negative control and 5% of sodium dodecyl sulphate solution in water was used as positive control. Subsequently, viability of the tissues was assessed in MTT test and compared to the negative control. In the study, the percentage of viability obtained with the test substance was 4.9 %, therefore it was determined to be skin irritant. Under the study conditions, the test substance, mono- and di- C8-10 PSE was determined to be skin irritant (XCellR8, 2017).

Study 2: An in vitro study was conducted to determine the skin corrosion potential of the test substance, mono- and di- C8-10 PSE, using the Reconstructed Human Epidermis (RHE) Test Method, according to OECD Guideline 431, in compliance with GLP. Three tissues of the human skin model EpiDermTM were used per treatment with the test substance, positive and negative control. 50 µL of the neat test substance was topically applied on each tissue model. Demineralised water was used as negative control, and KOH as positive control. After 3 minutes and 1 h treatment, the test substance or the control substance was rinsed off from the tissues. Then, cell viability of the tissues was evaluated by addition of MTT. Results were compared to negative control. All validity criteria for the performed test were met. After 3 minutes and 1 h treatment, the mean viability values obtained with the test substance were determined to be 16.5% and 4.4%. The test substance did reduce the viability below 50% after 3 min and below 15% after 1 hour and should be considered as corrosive. Under the study conditions, the test substance was determined to be skin corrosive (XcellR8, 2017).

Skin irritation:

Based on the results ofin vitroskin irritation/corrosion studies, the test substance is determined to be skin corrosive with a classification as ‘Skin Corr. 1A; H314 - causes severe skin burns and eye damage’ according to EU CLP criteria (Regulation EC 1272/2008).

Eye irritation:

Based on the results ofin vivoskin irritation/corrosion studies, the test substance is determined to be corrosive to the eyes with a classification as ‘Eye Damage 1; H318- causes serious eye damage’ according to CLP criteria (Regulation EC 1272/2008). Labelling for this endpoint is covered by the above classifications for skin effects.