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Registration Dossier
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EC number: 300-346-5 | CAS number: 93925-43-0
Skin irritation / corrosion
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:
- 2 012
- 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
- 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
Constituent 1
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
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