Methyl 2-benzoylbenzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July-August 2014

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species and strain: RccHan:WIST rats
Source: Harlan Laboratories S.r.l. S.Pietro al Natisone (UD), Zona Industriale Azzida, 57 33040, Italy
Hygienic level at arrival: SPF
Number of animals: 5 animals/sex
Sex: Male and female, female rats will be nulliparous and non-pregnant.
Age of animals at dosing: Young adult rats
Planned body weight range at dosing: Between 200 g and 300 g
Acclimatization time: At least 5 days

Housing: Individual caging
Cage type: Type II. polypropylene/polycarbonate
Bedding: Laboratory bedding
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 15-20 air exchanges/hour
Enrichment: Rodents are housed with deep wood sawdust bedding to allow digging and other normal rodent activities.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The back of the animals was shaved (approximately 10% area (and not less) of the total body surface) approximately 24 hours prior to treatment. The test item was applied as supplied as a single dose to the shaved skin and remained in contact with the skin for the 24 hour exposure period. Sufficient water was added to dampen the material to ensure good contact with the skin. Sterile gauze pads (approximately 5 x 5 cm) were placed on the skin of the rats to cover the test item. The gauze was kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped with semi occlusive plastic wrap. At the end of the exposure period, residual test item was removed, using body temperature water.

Duration of exposure:

24 hours

Doses:

A limit dose of 2000 mg/kg bw was chosen.

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Administration of the test item at a dose level of 2000 mg/kg body weight did not cause any mortality.

Clinical signs:

other: No clinical signs were observed after treatment with the test item or during the 14-day observation period. No local dermal signs were observed after treatment with the test item during the 14 day observation period.

Gross pathology:

There was no evidence of the macroscopic findings at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of the test item RCX 14-672 was found to be higher than 2000 mg/kg bw in male and female rats.

Executive summary:

The acute dermal median lethal dose (LD50) of the test item RCX 14-672 was found to be higher than 2000 mg/kg bw in male and female rats.