4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 6 Feb 1996 to 19 Feb 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

fully occlusive covering

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

EC Number:

260-350-7

EC Name:

4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Cas Number:

56706-10-6

Molecular formula:

C18H42O6S2Si2

IUPAC Name:

4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Constituent 2

Reference substance name:

S2

IUPAC Name:

S2

Test animals

Species:

rabbit

Strain:

other: White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ASTA Medica AG, GERMANY
- Age at study initiation: 18-53 months
- Weight at study initiation: 2.41-2.71 kg
- Housing: 1/cage
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: at least 1 day


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0-20.0
- Humidity (%): 48-78
- Photoperiod (hrs dark / hrs light): 12h/12 h

IN-LIFE DATES: From: 1996-02-06 To: 1996-02-19

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: control: adjacent area of skin

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): neat

Duration of treatment / exposure:

4 h

Observation period:

9 days (study period suggests 13 days)

Number of animals:

3 (males)

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm2
- % coverage: not stated
- Type of wrap if used: occlusive: cellulose gauze/cellulose fibre coated with natural rubber/synthetic film glue

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing "as far as possible"
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize, 1944; OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

erythema, eschar and oedema

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 1, 24, 48, 72 h

Score:

1.5

Max. score:

8

Reversibility:

fully reversible within: 9 days

Remarks on result:

other: EU criteria (24, 48, 72 h): no two animals with a mean score >=2.

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 9 days

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within:

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 9 days

Remarks:

Initial edema reversed by 24 hours, edema observed days 4, 6 and 7

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

6 days

Remarks on result:

no indication of irritation

Other effects:

No systemic effects reported

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema & Eschar	Edema
	Max. score: 4	Max. score: 4
60 min	1,0,1	0,0,0
24 h	1,1,2	1,0,1
48 h	1,1,2	0,0,1
72 h	1,1,2	0,0,1
4 days	2,1,2	1,0,11
6 days	2,0,0,	1,0,0,
7 days	1	1
9 days	0	0
Average 24h, 48h, 72h	1.3	0.4
Reversibility*)	c	c
Longest time (unit) for reversion	9 days	9 days

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An otherwise reliable study, conducted in accordance with OECD 404 and GLP but using an occlusive dressing, found the test material to be slightly irritating (PII 1.5) based on readings at 1, 24, 48 and 72 h. This result would be judged to be not irritating according to EU criteria. It is possible that the use of a semi-occlusive dressing might reduce irritation.