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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-cyanoethyl 3-oxobutanoate
EC Number:
613-755-1
Cas Number:
65193-87-5
Molecular formula:
C7H9NO3
IUPAC Name:
2-cyanoethyl 3-oxobutanoate

In vitro test system

Test system:
human skin model

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
92

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean value of cell viability was recorded to be 92 % (rounded). The test item was thus shown to be not irritating to reconstructed human skin in vitro.
Executive summary:

A study was performed for the assessment of the skin irritancy of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 439 and EU Test Method B.46. The mean value of cell viability was recorded to be 92 % (rounded). The test item was thus shown to be not irritating to reconstructed human skin in vitro.