Methyl 2-benzoylbenzoate

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23rd October - 11th November 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

Chemical name: methyl-2-benzoylbenzoate
Batch no.: 103189
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: 99.6%

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Strain Crl:HanWist(Glx:BRL)BR

Route of administration:

oral: gavage

Vehicle:

other: 15% methyl cellulose

No. of animals per sex per dose:

5

Control animals:

no

Sex:

male

Dose descriptor:

discriminating dose

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Single oral administration of methyl-2-benzoylbenzoate at a dose level of 2000 mg/kg caused no death in a group of ten fasted rats.

Clinical signs:

other: No clinical signs observed.

Gross pathology:

No macroscopic changes were observed for animals killed on Day 15.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single oral administration of methyl-2-benzoylbenzoate at a dose level of 2000 mg/kg caused no death in a group of ten fasted rats. Accordingly, the discriminating dose was 2000 mg/kg and the acute oral minimum lethal dose of methyl-2-benzoylbenzoate to rats was found to exceed 2000 mg/kg.

Executive summary:

The acute oral minimum lethal dose of methyl-2-benzoylbenzoate to rats was found to exceed 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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

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.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Justification for classification or non-classification

Based on the results of the available studies, methyl-2-benzoylbenzoate does not need to be classified for acute toxicity, according to Regulation EC 1272/2008 and Directive 67/548/EEC.