2-butanone-O,O',O''-(phenylsilylidyne)trioxime

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-02-23 to 1999-03-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to EEC method B3 and OECD guidleline 402 with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-360-6

EC Name:

-

Cas Number:

34036-80-1

Molecular formula:

C18H29N3O3Si

IUPAC Name:

6-{[(butan-2-ylidene)amino]oxy}-3,9-dimethyl-6-phenyl-5,7-dioxa-4,8-diaza-6-silaundeca-3,8-diene

Constituent 2

Reference substance name:

2-butanone-O,O',O''- (phenylsilylidyne)trioxime

IUPAC Name:

2-butanone-O,O',O''- (phenylsilylidyne)trioxime

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): OS-9000
- Physical state: Clear liquid
- Analytical purity: >92%
- Lot/batch No.: M-350B
- Expiration date of the lot/batch: 12 February 2000

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Spague Dawley CD obtained fiom Harlan U.K. Ltd., Bicester, Oxon, England.
- Age at study initiation: eight to eleven weeks
- Weight at study initiation: 219 to 242 g
- Fasting period before study:
- Housing: Individually in stainless steel metal cages (20cm high x 39cm wide x 39cm long) until Day 3 when they were returned to group housing.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-22 ºC
- Humidity: 28- 52 %
- Photoperiod: time switch to provide 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorso lumbar region, equivalent approximately to 10% of the total body weight.
- % coverage: Treatment area (50mm x 50mm) was covered with porous gauze with a non-irritating dressing
- Type of wrap if used: Further covered by a waterproof dressing encircled firmly around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm water (38ºC) and blotted dry with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL:
- Amount(s) applied (volume or weight with unit): 1.947 mL/kg bw
- Concentration (if solution): Administered as supplied.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 rats per sex and per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed on at least two occasions during the day. Bodyweight of each rat was recorded on days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, dermal responses (using the scoring system according to the guidelines), body weight, macroscopic pathology (opening the thoracic and abdominal cavities)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths throughout the study.

Clinical signs:

other: There was no evidence of a systemic response in any animal throughout the study.

Gross pathology:

No macroscopic abnormalities were observed for animals killed at study termination.

Other findings:

Dermal responses: No treatment related dermal reactions were seen in any animal during the study.

Any other information on results incl. tables

The acute lethal dermal dose to rats was demonstrated to be greater than 2000 mgkg bodyweight.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal dermal dose to rats was demonstrated to be greater than 2000 mg/kg bodyweight.

Executive summary:

The study was designed to assess the toxicity of the test item following a single dermal administration to the rat according to EEC method B3 and OECD guideline 402. Five rats per sex rats were exposed by topical application (dorso lumbar region) to 2000 mg/kg bw under occlusive conditions. After 24 hours of exposure the treated area was washed with water. No treatment related dermal reactions were seen in any animal during the study. No deaths and no evidence of a systemic response in any animal throughout the study. The acute lethal dermal dose to rats was demonstrated to be greater than 2000 mg/kg bodyweight.