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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2008-04-29 to 2008-05-02
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP lab following OECD guideline

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: OECD Guideline 431 (In vitro skin corrosion: Human Skin Model Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 2-ethylhexylal
- Physical state: liquid
- Analytical purity: 99.82%
- Lot/batch No.: 0803181500
- Expiration date of the lot/batch: 2009-03-18
- Storage condition of test material: room temperature

Test animals

other: Episkin Standard Model

Test system

Type of coverage:
unchanged (no vehicle)
not required
Duration of treatment / exposure:
3, 60 and 240 minutes
Observation period:
3 hours after end of exposure

Results and discussion

In vitro

Irritation / corrosion parameter:
other: other: Cell Viability
> 35
Remarks on result:
Basis: mean. Time point: 240 minutes. Reversibility: no data. Remarks: Following OECD Guideline 431: the cell viability is never below 35% even after 4 hours exposure. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Migrated information: non corrosive
According to the obtained results (cell viability never below 35% for tested exposure time) and reporting to the UN and EU classification criterias for corrosive chemical categorisation, we can conclude that the organic solvent 2-ethylhexylal can be classified as non corrosive.
Executive summary:

The objective of this study is to predict and classify the skin corrositivity potential of the chemical product 2-ethylhexylal according to chemical safety regulation, by assessment of its effect on a reconstructed human epidermis.

The principle of this test is based on the experience that corrosive chemicals show cytotoxic effect following short-term exposure on the stratum corneum of the epidermis. The test protocol does not provide adequate information on skin irritation. The assay was conducted according to the OECD guideline n° 431 "In vitro skin corrosion: Human Skin Model Test".

The Episkin is a highly differentiated and stratified epidermis validated model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum obtained after a culture period. Its use for skin corrositivity testing involves topical application of the test material to the surface of the epidermis, and the subsequent assessment of its effects on cell viability.

The selected positive and negative reference chemicals are phosphate buffer saline and acetic acid glacial.

Corrositivity potential of 2-ethylhexylal involved topical application of test item to the surface of the reconstructed human epidermis and the subsequent assessment of its effect on cell viability. 10µl of the test item was applied topically to the epidermal model for 3, 60 and 240 minutes (3 epidermis units were used per test material, 2 for positive and 1 for negative controls and time exposure). At the end of the treatment, all residual test item and chemical controls were removed by thoroughly rinsing epidermis units with 25 ml of sterile phosphate buffered saline solution. The resulting cell viability was further assessed by incubating tissues for 3 hours at 37°C, 5% CO2 atmosphere with MTT (0.3 mg/ml) in assay medium. The basis of this test is that viable cells metabolize MTT into intra-cellular formazan crystals. The precipitated formazan was finally extracted using acidified isopropanol and quantified spectrophotometrically at 550 nm by comparison to a blank (acidified propanol).

According to the obtained results (cell viability never below 35% for tested exposure time) and reporting to the UN and EU classification criteria for corrosive chemical categorization, we can conclude that the organic solvent 2-ethylhexylal can be classified as non corrosive (OECD 431: non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%).