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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 13 - 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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
Reference substance name:
A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime
EC Number:
458-680-3
EC Name:
A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime
Cas Number:
797751-44-1
Molecular formula:
not applicable, multiconstituent substance
IUPAC Name:
3-ethenyl-3-methoxy-6-methyl-2,4-dioxa-5-aza-3-silahept-5-ene; 5-ethenyl-2,8-dimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene; 5-ethenyl-5-methoxy-2,8-dimethyl-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga
- Age at study initiation: approximately 8 weeks (males) and 12 weeks (females)
- Weight at study initiation: 245-254g (males) and 229-240 g (females)
- Housing: single caging in Makrolon cages type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 22 ºC
- Humidity (%): average 56%
- 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

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg per kg body weight
Duration of exposure:
24 hours
Doses:
One dose level of 2000 mg/kg body weight
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed 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 were determinate before administration, 7 and 14 days after administration.
- Necropsy of survivors performed: yes

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:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: No relevant findings in life were noted, except for signs of discomfort in 1 male rat a day after the test substance administration. The clinical signs were chromodacryorrhoea, attributed to the discomfort caused by the dressing and was not considered to
Gross pathology:
Effect on organs: no relevant findings were noted.
Other findings:
No relevant local findings were noted.

Any other information on results incl. tables

Body weights and body weight gain:

 

Individual data, mean and standard deviation SD

Sex

No.

before
administr.

7 days
p.a.

14 days
p.a.

death

0-7 days
p.a.

7-14 days
p.a.

 

11

253

276

320

-

23

44

2000 mg/kg

12

251

298

351

-

47

53

male

13

245

278

322

-

33

44

 

14

246

268

311

-

22

43

 

15

254

284

332

-

30

48

 

mean

250

281

327

-

31.0

46.4

 

SD

4

11

15

-

10.1

4.2

 

16

239

244

263

-

5

19

2000 mg/kg

17

236

241

263

-

5

22

female

18

240

249

266

-

9

17

 

19

234

241

257

-

7

16

 

20

229

232

254

-

3

22

 

mean

236

241

261

-

5.8

19.2

 

SD

4

6

5

-

2.3

2.8

Synopsis of Results

dose
(mg/kg)

sex

No. of animals

prominent findings

exposed

affected

deceased

in life

post mortem

 

 

 

 

 

systemic

local

 

2000

male

5

1

0

signs of discomfort

none

none

2000

female

5

0

0

none

none

none

presence of clinical signs

1 d p.a.

full recovery of the survivors

yes

body weights

all animals gained weight in the weeks after dosing

sex differences

no

findings in life and post-mortem indicate

no toxic effects

 

 

LD50, dermal

> 2000 mg/kg body weight

Applicant's summary and conclusion

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
No test substance related effects were noted from clinical observations or post-mortem examination at a dose of 2000 mg test substance per kg body weight.
The LD50, dermal of the test substance is > 2000 mg/kg body weight in rats.
Executive summary:

The Acute Dermal Toxicity assay for the test substance was performed (According to OECD 402 Guideline) in Sprague Dawley rats. One female group and one male group, of 5 animals each one, 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 observation was conducted at 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 weight was controlled before the administration, 7 and 14 days after the administration. All animals were subjected to gross necropsy.

No test substance related effects were noted from clinical observations or post-mortem examination at a dose of 2000 mg test substance per kg body weight. The LD50dermal of the test substance was > 2000 mg/kg body weight in rats.