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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:
11 Oct - 02 Nov 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted Jul 2015
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
May 2008
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
Aug 1998
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147
Version / remarks:
Nov 2000
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Remarks:
Food and Consumer Product Safety Authority (VWA), Utrecht, The Netherlands

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane
EC Number:
300-346-5
EC Name:
Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane
Cas Number:
93925-43-0
Molecular formula:
C4H8O2, C20H44O4SiSn, C24H52O6SiSn, C40H84O8SiSn2, C60H128O12Si2Sn3, C80H172O16Si3Sn4, C100H216O20Si4Sn5
IUPAC Name:
Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 25 - 29 weeks
- Weight at study initiation: 3.72 - 3.88 kg
- Housing: Animals were individually housed in labeled cages with perforated floors (67 x 62 x 55 cm) and shelters (40 x 32 x 23 cm).
- Diet: Global Diet 2030, pelleted, 100 grams per day; hay and wooden sticks
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.8 – 21.2
- Humidity (%): 43 - 77
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
7 days
Reading time points: 1, 24, 48, 72 hours and 7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap if used: The test substance was applied to the skin of one flank using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed using tap water and watery ethanol (50% v/v)
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
The skin irritation effects (erythema, oedema, scales, dryness) were assessed 1, 24, 48, 72 h and 7 days after removoal of the dressings and test substance.

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: Animal #1, #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
other: Animal #2, #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Very slight erythema (grade 1) at the 1-, 48- and 72-h reading time point and well-defined erythema (grade 2) at the 24-h reading time point were observed in Animal #1 and #2. In Animal #3 very slight erythema (grade 1) were noted at the 1-, 24- and 48-h reading time point. Very slight edema (grade 1) at the 1- and 48-h reading time point and well-defined edema (grade 2) at the 24-h reading time point occured in Animal #1, whereas only very slight edema (grade 1) were noted in Animal #2 and #3 at the 1-, 24- and 48-h reading time point. The skin irritation had resolved within 72 h after exposure in Animal #3 and within 7 Days after exposure in Animal #1 and #2, respectively.

Any other information on results incl. tables

Table 1: Individual skin irritation scores

Observation time Rabbit no.
1 2 3
Erythema (0-4) Edema (0-4) comments Erythema (0-4) Edema (0-4) comments Erythema (0-4) Edema (0-4) comments
1 h 1 1 - 1 1 b 1 1 b
24 h 2 2 b 2 1 b 1 1 b
48 h 1 1 b 1 1 b 1 0 b
72 h 1 0 - 1 0 - 0 0 -
7 days 0 0 - 0 0 - 0 0 -

b: Dry remnants of the test substance present

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008