Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]

Endpoint summary

Description of key information

Phosphoric acid, 2-ethylhexyl ester, compound with 2,2'-iminobis[ethanol] was evaluated for skin corrosion in line with OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method) using the EpiDerm™ tissue model. Based on the resulting tissue viability of 27.1 % after a 3-minute exposure and 26.5 % after a 60-minute exposure, the registered substance was classified as Skin Corr. 1B/1C.

In accordance with Annex VII of REACH, Column 2, as phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] has been classified as corrosive to the skin, studies for eye irritation and skin irritation do not need to be conducted.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Remarks:

EpiDerm™ reconstructed human epidermis

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: Single topical application of 50µl of neat test item

NEGATIVE CONTROL
- Amount applied: 50µl
- Lot/batch no.: RNBG4913

POSITIVE CONTROL
- Amount applied: 50µl
- Lot/batch no.: SLBD3295V

Duration of treatment / exposure:

3 and 60 minutes

Number of replicates:

Triplicate

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 minutes

Value:

27.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 minutes

Value:

26.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

After a 3- and 60-minute exposure period of EpiDerm™ reconstructed human epidermis to phosphoric acid, 2-ethylhexyl ester, compound with 2,2'-iminobis[ethanol], the registered substance was determined to be corrosive to human skin (Skin Corr. 1B/1C) (CLP Regulation (EC) No. 1272/2008). This classification was based on a resulting tissue viability of 27.1 and 26.5 % after 3 and 60 minutes, respectively.

Executive summary:

An in vitro experiment was undertaken to determine the skin corrosion potential of phosphoric acid, 2-ethylhexyl ester, compound with 2,2'-iminobis[ethanol] in line with OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method). The study was compliant with GLP. A single topical application of phosphoric acid, 2-ethylhexyl ester, compound with 2,2'-iminobis[ethanol] was applied reconstructed human epidermis Epiderm™ neat at 50 µl. A negative control of tissue grade sterile water and positive control of potassium hydroxide was run in parallel and similarly applied at 50 µl. Epiderm™ was exposed to test and reference items for a 3- and 60-minute period at 37 °C, 5 % CO2, 95 % RH. Following the exposure period and prior to final measurement of the tissue viability, all tissues were rinsed, loaded with MTT (3-[4,5dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide), and extracted in isopropanol. Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are subsequently used to make a prediction of the corrosion potential.

All controls were valid and demonstrated the reliability of the test system. Mean tissue viability, calculated as a percentage of the negative control, was 27.1 % after a 3-minute exposure and 26.5 % after a 60-minute exposure. According to CLP Regulation (EC) No. 1272/2008, phosphoric acid, 2-ethylhexyl ester, compound with 2,2'-iminobis[ethanol] should be regarded as corrosive to human skin and classified as Skin Corr. 1B/1C.

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

Justification for classification or non-classification

Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] is classified as Skin Corr 1B; 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 phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol].