A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 28 to October 12, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

According to OECD 402 Guideline, with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

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:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime

EC Number:

460-110-3

EC Name:

A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime

Cas Number:

797751-43-0

Molecular formula:

not applicable, multiconstituent substance

IUPAC Name:

2,5,8-trimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene; 3-methoxy-3,6-dimethyl-2,4-dioxa-5-aza-3-silahept-5-ene; 5-methoxy-2,5,8-trimethyl-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene

Details on test material:

- Name of test material (as cited in study report): Wasox-MMAC2
- Physical state: Clear liquid.
- Lot/batch No.: 1000024854.
- Expiration date of the lot/batch: December 2005.
- Storage condition of test material: Storage under a nitrogen atmosphere at ambient temperature
- Other: Handling precautions: Exothermic reaction with water or humidity from the air.

Test animals

Species:

rat

Strain:

other: CRL:CD (SD) BR SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiqa, 0-97633 Sulzfeld.
- Age at study initiation: approximately 8 weeks (males) and 12 weeks (females)
- Weight at study initiation: 246-260g (males) and 232-240 g (females)
- Housing: Single caging in Makroion cages type 111(39 cm x 23 cm x 18 cm). Wire mesh lids. Bedding material: aspen wood chips.
- Diet (e.g. ad libitum): ad libitum (Altromin 1324 forte)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 22 ºC (continuous control and recording).
- Humidity (%): average 56% (continuous control and recording).
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: an area of 6.5 cm x 8 cm (52 cm2) on the dorsal thoracal region
- % coverage: at least 10% of the estimated body surface.
- Type of wrap if used: A cellulose patch with the test substance was applied and held in place by fixing marginally with non irritating tape and covered semi-occlusively by a dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was wiped off using wet cellulose tissue, if necessary.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex and per dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations: within the periods 0-0.5, >0.5-1, >1-2, >2-4 and >4-6 hours after administration of the test substance and then at least once a day for a total of 2 weeks.
Body weights: before administration, 7 and 14 days after administration.
- Necropsy of survivors performed: yes.
- Other examinations performed:
Clinical signs: skin, fur, eyes, occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
Body weight: body weight gain for each week of the study (0-7 days, 7-14 days).
Gross pathology.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until the scheduled termination of the study.

Clinical signs:

other: All animals were normal during the entire observation period. Exposed skin was not found to be altered by the test substance.

Gross pathology:

All animals were normal at terminal necropsy.

Other findings:

No noteworthy sex difference in the response to the test substance was derived from clinical observations or post-mortem findings.

Any other information on results incl. tables

Synopsis of Results

Sex	Animal	Dose	Number of animals
	Nos.	(mg/kg)	exposed	affected	deceased
Male	1-5	2000	5	1	0
Female	6-10	2000	5	0	0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

LD50 value of test article Wasox-MMAC2 in rats by dermal route at 24 h exposure period is higher than 2000 mg/kg bw.

Executive summary:

The Acute Dermal Toxicity assay for the test substance Wasox-MMAC2 was performed according to OECD 402 Guideline in Sprague Dawley rats. 5 animals per sex were treated with a single dose of 2000 mg/kg body weight (limit test). The test material was applied via a patch to an area of approximately 6.5 x 8 cm on the dorsal thoracal region, and covered by a semi-occlusive dressing. The duration of the exposure was 24 hours. Clinical signs and body weights were monitored for 14 days after administration and all animals were subjected to gross necropsy. All animals survived until the scheduled termination of the study. The body weights were inconsplcuous in males during the study. No body weight gain was observed in one female in the first week after administration (0 -7 days) but was inconspicuous in all females in the second (7 - 14 days). All animals were normal during the entire observation period and at terminal necropsy. The dermal LD50 of the test substance was > 2000 mg/kg body weight.