Reaction mass of 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 16 Nov 1999 to 19 Nov 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP. The test material was similar to the registered substance but contained a higher proportion of an S3 isomer. The original study and the read-across are considered to be reliability 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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:

Referred to as 56706-10-6

IUPAC Name:

Referred to as 56706-10-6

Constituent 2

Reference substance name:

Multi-constituent substance; constituents 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane (CAS 56706-10-6), 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane (CAS 56706-11-7) and 4,4,12,12-tetraethoxy-3,13-dioxa-8-thia-4,12-disilapentadecane (CAS 60764-86-5)

IUPAC Name:

Multi-constituent substance; constituents 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane (CAS 56706-10-6), 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane (CAS 56706-11-7) and 4,4,12,12-tetraethoxy-3,13-dioxa-8-thia-4,12-disilapentadecane (CAS 60764-86-5)

Constituent 3

Reference substance name:

Low purity S2

IUPAC Name:

Low purity S2

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Covance Research Products, USA

- Age at study initiation: young adult

- Weight at study initiation: 2646-2689 g

- 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 7days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 68.4-68.7 deg F

- Humidity (%): 37.5-40.6

- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 1999-11-16 To: 1999-11-19

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: control: adjacent area of skin

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied: 0.5 ml

- Concentration: neat (100%)

Duration of treatment / exposure:

4 h

Observation period:

3 days

Number of animals:

3 (1 male, 2 female)

Details on study design:

TEST SITE

- Area of exposure: 2.5 x 2.5 cm = 6.25 cm2

- % coverage: not stated

- Type of wrap if used: semi occlusive: 2-ply gauze held with Micropore tape, overwrapped with gauze binder held with Dermiform tape


REMOVAL OF TEST SUBSTANCE

- Washing (if done): wiped with moist paper towels

- Time after start of exposure: 4 h

SCORING SYSTEM: Draize, 1965

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 30-60 mins

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 0.5-1, 24, 48, 72 h

Score:

< 0.1

Max. score:

8

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: EU criteria (24, 48, 72 h): erythema and oedema = 0

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #1

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 #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

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	Edema
	Max. score: 4	Max. score: 4
60 min	1,0,0	0,0,0
24 h	0,0,0	0,0,0
48 h	0,0,0	0,0,0
72 h	0,0,0	0,0,0
Average 24h, 48h, 72h	0/4	0/4
Reversibility*)	c	n/a
Average time (unit) for reversion	24 h	n/a

 *) 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:

A reliable study has been conducted in accordance with the OECD 404 and in compliance with GLP. The test material was similar to the registered substance but contained a higher proportion of an S3 isomer. The test material was found to be not irritating to the skin of rabbits.