Registration Dossier
Registration Dossier
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EC number: 915-673-4 | CAS number: 211519-85-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: FDA (1965). Part 191, Section 11.
- Deviations:
- not applicable
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction Mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
- EC Number:
- 915-673-4
- Cas Number:
- 211519-85-6
- Molecular formula:
- For the substance, C18H42O6SnSi2 (n = 2 – 4) Constituent 1 (S2): C18H42O6S2Si2 Constituent 2 (S3): C18H42O6S3Si2 Constituent 3 (S4): C18H42O6S4Si2
- IUPAC Name:
- Reaction Mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No information available
- Age at study initiation: No information available
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: Animals were individually housed in V2A steel cages with a ground area of 0.4 m2
- Diet: ALTROMIN 2023 ad libitum except during treatment
- Water: Tap water ad libitum except during treatment
- Acclimation period: No information available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°
- Humidity (%): 60 ± 3%
- Air changes (per hr): No information available
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: No information available
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Shaved, intact (3 animals) or abraded (3 animals)s
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration (if solution): Neat - Duration of treatment / exposure:
- 24 h exposure
- Observation period:
- Observed at 48, 72, 96 and 120 h following application.
- Number of animals:
- 6 (3 male, 3 female), with 3 intact and 3 abraded
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No information available
- Type of wrap: Plastic foil fastened with a gum patch.
REMOVAL OF TEST SUBSTANCE
- Washing: No information available
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- 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
- Remarks:
- intact skin
- 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
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- 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
- Remarks:
- intact skin
- 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
- Remarks:
- intact skin
- 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
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- No skin reactions or clinical signs were observed in any animal. Re-growth of hair was unaffected by treatment. See Table 1 below.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time point up to removal of each animal from the test
Score at time point*/ Reversibility |
Erythema |
Oedema |
Max. score: 4 |
Max. score: 4 |
|
24 h (removal of patch) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h (24h following removal) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h (48h following removal) |
0/0/0/0/0/0 |
0/0/0/0/0/0s |
96 h (72h following removal) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
120 h (96h following removal) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h (following removal) |
0 |
0 |
Reversibility** |
n/a |
n/a |
Average time (unit) for reversion |
n/a |
n/a |
* Results for 6 animals shown: 3 abraded, 3 non-abraded, all individual scores also equal to 0.
** 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:
- In a reliable skin irritation study conducted in accordance to an appropriate national test guideline similar to OECD Test Guideline 404, the substance was found to be non-irritant to rabbit skin. The test pre-dated GLP.
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