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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
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-benzoylbenzoic acid
EC Number:
201-612-2
EC Name:
2-benzoylbenzoic acid
Cas Number:
85-52-9
Molecular formula:
C14H10O3
IUPAC Name:
2-benzoylbenzoic acid

In vitro test system

Test system:
human skin model
Source species:
human
Vehicle:
unchanged (no vehicle)
Details on test system:
The test item was applied as supplied
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
16 mg
Duration of treatment / exposure:
42 min
Duration of post-treatment incubation (if applicable):
42h
Number of replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test item - Mean percent viability
Value:
89.1
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test item - Run 1
Value:
100.4
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test item - Run 2
Value:
89
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test item - Run 3
Value:
78
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Negative control - Mean percent viability
Value:
100
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Positive control - Mean percent viability
Value:
1.8
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation potential was tested according to OECD 439 guideline on reconstructed human epidermis. The mean percent viability of the treated tissues was 89.1%. In accordance with the regulation EC n°1272/2008, the test item has to be considered as non-irritant to skin. It corresponds to UN GHS No category.
Executive summary:

The skin irritation potential was tested according to OECD 439 guideline on reconstructed human epidermis. The mean percent viability of the treated tissues was 89.1%. In accordance with the regulation EC n°1272/2008, the test item has to be considered as non-irritant to skin. It corresponds to UN GHS No category.