Methyl 2-benzoylbenzoate

Skin irritation / corrosion

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:

2014

Report date:

2014

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

Test material information

Constituent 1

Reference substance name:

Methyl 2-benzoylbenzoate

EC Number:

210-112-3

EC Name:

Methyl 2-benzoylbenzoate

Cas Number:

606-28-0

Molecular formula:

C15H12O3

IUPAC Name:

methyl 2-benzoylbenzoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): RCX 14-672
- Chemical name: methyl-2-benzoylbenzoate
- Substance type: organic
- Physical state: white to light yellowish powder
- Analytical purity: >99%
- Impurities (identity and concentrations): unknown
- Lot/batch No.: N14003
- Expiration date of the lot/batch: 30 November 2015
- Stability under test conditions: stable
- Storage condition of test material: controlled room temperature (15-25°C, below 70 RH%), protected from light and humidity

Specific details on test material used for the study:

Identification: RCX 14-672
Chemical name: methyl-2-benzoylbenzoate
Batch no.: N14003
CAS no.: 606-28-0
EC no.: 210-112-3
Molecular formula: C15H12O3
Molecular mass: 240.3 g/mol
Description: white to light yellowish powder
Purity: >99% (gas chromatography)
Water solubility: 117.7 mg/l
Test item storage: at room temperature, protected from light
Stability: stable under storage conditions
Expiry date: 30 November 2015

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

82.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

not irritating

Executive summary:

An in vitro skin irritation test of RCX 14-672 test item was performed in a reconstructed human epidermis model. EPISKIN-SM is designed to predict and classify the irritation potential of chemicals by measuring its cytotoxic effect as reflected in the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay. The irritation potential of the test item was evaluated according to the OECD Guideline No. 439. Disks of EPISKIN (three units) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of the test item was terminated by rinsing with Phosphate Buffered Saline (PBS). The epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in an incubator with 5% CO2 protected from light. The precipitated formazan crystals were then extracted using acidified isopropanol and quantified spectrophotometrically.

Following exposure with RCX 14-672, the mean cell viability was 82.1% compared to the negative control (after adjustment for colour). This is above the threshold of 50%, therefore the test item was considered as being non-irritant. The experiment met the

validity criteria, therefore the study was considered to be valid.

In conclusion, in this in vitro EPISKIN model test with RCX 14-672, the results indicate that the test item is Non Irritant (NI).