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Toxicological information

Skin irritation / corrosion

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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

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

Resultsopen allclose all
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
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
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
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
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
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
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
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.

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