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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Storage No.: EX0307
Chemical name: 1-[(3 -Aminopropyl)dimethyl-silyl]-2,2dimethyl- 1-aza-2-sila cyclopentane
Physical State at RT: liquid
Storage conditions: ambient, RT, protected from light
Safety precautions: Routine hygienic procedures were sufficient
to assure personnel health and safety.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

New Zealand White Rabbits Hsdlf:NZW. 3 female animals were used.
The animals were derived from a controlled full barrier maintained breeding system (spf).
Source: Harlan Winkelmann GmbH, D-33178 Borchen.

Husbandry:
- Semi-barrier in air conditioned rooms
- Temperature: 18 ± 3 °C
- ReI. humidity: 55 ± 10%
- Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30
- Air change: at least 10 x I hour
- Free access to Altromin 2123 maintenance diet for rabbits,
rich in crude fibre, totally pathogene free (TPF)
- Free access to tap water (drinking water, municipal residue control,
microbiol. controlled periodically)
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatization period

Test system

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

not specified

Controls:

other: other flank served as control

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

15 days

Number of animals:

3

Details on study design:

The test item was applied in a single dose to a small area (approx. 6 cm2 ) of skin on one side of the dorsal area with a gauze patch, which was held in
place with non-irritating tape. The untreated other side served as control. The test item was applied to the patch first, and then applied to the skin. The patch was fixed with a semi-occlusive dressing.
Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal as well as daily until day 15.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: all

Time point:

other: 24-96 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 15 days

Results 2

Irritation parameter:

edema score

Basis:

animal: all

Time point:

other: 24 - 96 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

The test item showed moderate to severe irritant effects on the intact skin after a contact time of 4 hours.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item showed moderate to severe irritant effects on the intact skin after a contact time of 4 hours.

Executive summary:

In this irritation study the test item was applied to one site of the closely clipped backs of 3 rabbits (strain NZW) at a dose of 0.5 ml per application site. The untreated other side served as control. The application site was covered with a semi - occlusive bandage for a 4 hour - contact time. Observations were recorded and compared to the control sites. 24 h, 48 h, 72 h, 96h, l20h, 144h, 168h, 192h and 216 h after removal of the dressing in all test animals erythema grade 4 as well as necrosis (extensive area in animal No. 460, small areas in animals No. 457 and 459) were found. At the 240h observation all necrosis had disappeared in all animals, as

necrotic tissues have been fully detached from the skin. But erythema (grade 4 in animal No. 457 and animal No. 460, grade 3 in animal No. 459) were still visible at the 240h and 264h readings.

Erythema decreased to grade 3 in all animals at the 288h reading, further to grade 2 in all animals at the 312h reading, to grade 1 at the 336h reading and disappeared at the 360h reading in all animals. No further clinical signs of toxicity were found.

The test item showed moderate to severe irritant effects on the intact skin after a contact time of 4 hours.

Considering the reported data of this irritation study including the development of necrosis, it can be stated that the test item showed moderate to severe irritant/corrosive effects.