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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:
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
other: erythema & eschar
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48, 72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 9 days
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.
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.