2,8,9-Trioxa-5-aza-1-silabicyclo[3.3.3]undecane, 1,1'-(dithiodi-3,1-propanediyl)bis-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-03-16 - 2004-04-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

477-700-1

EC Name:

-

Cas Number:

883794-93-2

Molecular formula:

Hill formula: C18H36N2O6S2Si2 CAS formula: C18H36N2O6S2Si2

IUPAC Name:

1-{3-[(3-{2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecan-1-yl}propyl)disulfanyl]propyl}-2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F.E.R., Italy
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 2 kg
- Housing: individually in stainless steel cages, 48x63x41 cm
- Diet (e.g. ad libitum): commercially available anti-biotic free pelleted laboratory diet
- Water (e.g. ad libitum): drinking water
- Acclimation period: 10 days before dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light):24 h cycle of 12h light/12 h dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g was reduced to a paste with approx 0.7 ml sterile water

Duration of treatment / exposure:

4 hours

Observation period:

1; 24; 48; 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: the dorsal surface of the trunk
- Type of wrap if used: a gauze square was placed directly on the treated skin, a strip of aluminium foil was placed over the treated site and the trunk was encircled with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): by gentle swabbing of the skin with cotton wool soaked in water at approx body temperature
- Time after start of exposure: after 4 h

SCORING SYSTEM: Draize Scoring System
The numerical scores obtained on assessing irritation at 24, 48 and 72 h examinations were summed and a mean calculated for each animal. The values for erythema and eschar formation were calculated separately from those obtained on assessing oedema.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No irritation was apparent following a 4 hour period of exposure to the test item.

Other effects:

There was no indication of a systemic effect of treatment.
Changes in body weight during the course of the study were not remarkable.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification: not required