3-[(2,2-Dimethyl-1,2-azasilolidin-1-yl)(dimethyl)silyl]-1-propanamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

CAS No.:388606-32-4
Batch No.: YH00701
Chemical name: 1-[(3-Aminopropyl)dimethylsilyl]-2,2dimethyl-1-aza-2-silacyc1opentan
Purpose: industrial chemical
Colour: colourless to yellowish
Physical state: liquid
Storage: at room temperature, protected from light and humidity
Safety precautions: Routine hygienic procedures were sufficient
to assure personnel health and safety

Test animals

Species:

rat

Strain:

other: HsdRccHan:WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

HsdRccHan : WIST rats (Full-Barrier), Sex: male and female. Body weight at the commencement of the study: male 240 - 258 g and female 213 - 219 g. 5 male and 5 female animals were used. The animals were derived from a controlled full barrier maintained breeding system (SPF).
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
The animals were barrier maintained (semi-barrier) in an air conditioned room
Temperature: 22 ± 3 °C
Rel. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Feeding ad libitum, ssniffR/M-H, 10 mm V1534-000, complete diet for rats/mice - maintenance, totally-pathogen-free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled peri-odically)
The animals were kept in Macrolon cages on Lignocel bedding.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The animals were marked for individual identification by tail painting. Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk by clipping. Not less than 10% of the body surface was cleared for the application. Prior to the application a detailed clinical observation was made of all animals. The test item was applied in a single dose by applying uni-formly over an area which was approx. 10% of the total body surface. Test item was held in con-tact with the skin with a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.

Duration of exposure:

24 h

Doses:

The test item was applied at a single dose (2000 mg/kg bw) by applying uniformly over an area which was approx. 10% of the total body surface.

No. of animals per sex per dose:

5 female, 5 male

Control animals:

no

Details on study design:

A careful clinical examination was made at least twice on the day of dosing and once a day thereafter. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

< 2 000 mg/kg bw

Remarks on result:

other: Exact LD50 could not be detected since all animals died during the exposition.

Mortality:

all animals died

Clinical signs:

All test animals: Complete destruction of skin, subcutanous tissue as well as musculature and compound-related mortality within 24 hours after
application. Cause of death was assumed to be the deep destruction over a large area (10% of the body surface).

Body weight:

not detected due to death of the animals

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the reported data of this dermal toxicity test it can be stated that the test item causes severe acute dermal toxic characteristics in a preliminary test.

Executive summary:

The test item 1-[(3-Aminopropyl)dimethylsilyl]-2,2dimethyl-1-aza-2-silacyclopentan was administered topically at a single dose (2000 mg/kg bw) by applying uniformly over an area which was approx. 10% of the total body surface according to OECD guideline 402. 5 male animals (HsdRccHan : WIST rats) as well as 5 female animals (HsdRccHan : WIST rats) were used. The test item was held in contact by an occlusive dressing with the skin throughout a 24-hour period. The occlusive dressing consisted of a gauze dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner. A careful clinical examination was made at least twice on the day of dosing and once a day thereafter. Necropsy was carried out to record gross

pathological changes. All test animals showed complete destruction of skin, subcutanous tissue as well as musculature and compound-related mortality within 24 hours after application. Cause of death was assumed to be the deep destruction over a large area (10% of the body surface) of the skin. The radical destruction was reconfirmed at necropsy. According to OECD 402 dosing test substances in a way to be known to cause marked pain and distress due to corrosive or irritating properties need not be carried out. Considering the reported data of this dermal toxicity test it can be stated that the test item causes severe acute dermal toxic characteristics in a preliminary test. For animal welfare reasons concerning the above reported results and in accordance with the sponsor no further animals were treated.