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Registration Dossier
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EC number: 249-385-9 | CAS number: 29043-70-7
Toxicological information
Skin irritation / corrosion
Currently viewing:
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 without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- not specified
- Remarks:
- Guideline described as "OECD-guidelines", no number given
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics
- GLP compliance:
- no
Test material
- Reference substance name:
- Dimethylbis(octadecyloxy)silane
- EC Number:
- 249-385-9
- EC Name:
- Dimethylbis(octadecyloxy)silane
- Cas Number:
- 29043-70-7
- Molecular formula:
- C38H80O2Si
- IUPAC Name:
- dimethylbis(octadecyloxy)silane
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 given in report
- Age at study initiation: no information given in report
- Weight at study initiation: average weight 2.5 kg
- Housing: individual cages
- Diet: standard diet ad libitum
- Water: ad libitum
- Acclimation period: no information given in report
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2°C
- Humidity (%): 50-60%
- Air changes (per hr): no information given in report
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: the test substance was applied to shaved skin and to abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- Observed immediately after removal of test substance, 48 hours and 7 days later
- Number of animals:
- 8
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: rubber cloth
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after bandage removed
- Time after start of exposure: 24 hours
SCORING SYSTEM: Primary irritation index
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours and 7 days after application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours and 7 days after application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Time point:
- other: 24 and 72 hours and 7 days after application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #4
- Time point:
- other: 24 and 72 hours and 7 days after application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #5
- Time point:
- other: 24 and 72 hours and 7 days after application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #6
- Time point:
- other: 24 and 72 hours and 7 days after application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: #7
- Time point:
- other: 24 and 72 hours and 7 days after application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: #8
- Time point:
- other: 24 and 72 hours and 7 days after application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- 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
- Remarks:
- at 24 and 72 hours and 7 days after application
- 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
- Remarks:
- 24 and 72 hours and 7 days after application
- 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
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- erythema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- erythema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- 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
- Remarks:
- 24 and 72 hours and 7 days after application
- 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
- Remarks:
- 24 and 72 hours and 7 days after application
- 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
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- edema score
- Basis:
- animal: '#7
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritation parameter:
- edema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- 24 and 72 hours and 7 days after application
- Irritant / corrosive response data:
- No erythema or edema was observed at any time point after application to shaved and to abraded skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dimethylbis(octadecyloxy)silane has been tested for acute skin irritation in an occlusive study conducted according to a protocol equivalent or similar to OECD TG 404. The test substance was applied to the shaved and also abraded skin of eight rabbits for twenty-four hours. No signs of skin irritation were observed. It is concluded that the test substance is not irritating to the skin.
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