Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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