Ethanone, 2,2-dichloro-1-(2,3-dihydro-3-methyl-4H-1,4-benzoxazin-4-yl)-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 January 1986 to 27 January 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dichloro-1-[(3R)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one; 2,2-dichloro-1-[(3S)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one

EC Number:

619-372-6

Cas Number:

98730-04-2

Molecular formula:

C11H11Cl2NO2

IUPAC Name:

2,2-dichloro-1-[(3R)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one; 2,2-dichloro-1-[(3S)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: H.A.R.E. Inc Hewitt NJ, USA
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.5 to 3.5 kg
-
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 3 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): standard laboratory conditions
- Humidity (%): standard laboratory conditions
- Air changes (per hr): standard laboratory conditions
- Photoperiod (hrs dark / hrs light): standard laboratory conditions


IN-LIFE DATES: From: 13.01.1986 To: 27.01.1986

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

The test material was moistened with water and applied to the shaved skin. It was covered by a gauze pad, which was held in place for 24 hours with a tape. Thereafter the material was removed with tap water. Collars prevented the rabbits from ingesting the test article.

Duration of exposure:

24 hours

Doses:

2010 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

Two week observation period. Clinical signs and bodyweights recorded.

Statistics:

Not applicable.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 010 mg/kg bw

Remarks on result:

other: No notable effects on any parameters at limit dose level

Mortality:

No mortality was observed.

Clinical signs:

other: No signs of systemic toxicity were recorded; however, a slight erythema was noted in one male on test day two.

Gross pathology:

At necropsy, no remarkable findings were noted.

Any other information on results incl. tables

No notable clinical signs were observed. One male had a slight erythematous dermal response on day 2 but otherwise there were no changes indicative of derrmal irritation or systemic toxicity.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the dermal LD50 was determined to be greater than 2010 mg/kg.

Executive summary:

A single dose of 2010 mg benoxacor /kg bw was administered topically to a group of five male and five female NZW rabbits.

No notable clinical signs were observed. One male had a slight erythematous dermal response on day 2 but otherwise there were no changes indicative of dermal irritation or systemic toxicity. No mortalities occurred and the median lethal dose was found to exceed 2010 mg/kg bw. Benoxacor (CGA154281 Technical) was found to be of low toxicity when applied topically to rabbit skin on a single occasion.