2,11-Dioxa-3,10-disiladodecane, 3,3,10,10-tetramethoxy-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-03-31 to 2009-04-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

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:

3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane

EC Number:

617-969-6

Cas Number:

87135-01-1

Molecular formula:

(CH3O)3Si(CH2)6Si(OCH3)3 C12 H30 O6 Si2

IUPAC Name:

3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane

Constituent 2

Reference substance name:

1,6,-Bis(trimethoxysilyl)hexane

IUPAC Name:

1,6,-Bis(trimethoxysilyl)hexane

Test material form:

other: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no details
- Age at study initiation: at least 6 months
- Weight at study initiation: 2911-3034 g
- Housing: 1/cage with suspended metal slat floor
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8-21.3
- Humidity (%): 42-49
- Air changes (per hr): 13.1
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: From: 2009-03-24 To: 2009-04-03

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat

Duration of treatment / exposure:

4 h exposure.

The pre-test involved 3 minute, 1 and 4 hour exposures of a single animal.

Observation period:

1 h, 24 h, 48 h, 72 h

Number of animals:

3 (for 4h test)

Details on study design:

TEST SITE
- Area of exposure: not stated
- % coverage: not stated
- Type of wrap if used: The dose was applied under a coverlet. The coverlet was secured in place, and then a layer of gauze bandage was wrapped over the coverlet and around the trunk followed by a layer of elastic wrap (Eiastoplast®) to prevent the removal and ingestion of the test article. An Elizabethan collar was placed around the animal's neck after the bandaging was completed to prevent the removal of the bandaging and remained in place for at least 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing: Following the appropriate exposure period, the bandaging was removed and any remaining test article was wiped from the skin using gauze moistened with reverse-osmosis water followed by dry gauze.

SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of dermal irritation or corrosion were seen at any scoring interval throughout the study on any animal (see table 1).

The Primary Irritation Index (PII) for 1 ,6-bis(trimethoxysilyl)hexane (supplied as Dow Corning® Z-6162 Silane) was calculated to be 0.0 for erythema and 0.0 for edema per EEC guidelines.

Other effects:

There were no deaths during the study. None of the animals had any remarkable body weight changes during the experimental phase of the study.

Any other information on results incl. tables

Table 1: Exposure for 4 hours

Irritant/corrosive response data for each of 3 animals at each observation time up to removal of each animal from the test.

Animal number	Erythema & eschar (24/48/72h)	Edema (24/48/72h)
	Max. score: 4	Max. score: 4
1	0/0/0	0/0/0
2	0/0/0	0/0/0
3	0/0/0	0/0/0
Primary irritation Index (PII)	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted in accordance with OECD 404 and GLP, found no evidence of irritation or corrosion when the test material was in 4h semi-occluded contact with rabbit skin. The Primary Irritation Index was 0.0 and the test material would be judged not irritating according to EC criteria.