Registration Dossier
Registration Dossier
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EC number: 214-685-0 | CAS number: 1185-55-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- This study generally follows current guidance for conducting skin irritation studies, but certain details regarding study conduct are missing. In addition, abraded skin was evaluated (only intact skin should be evaluated) and the study was not conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressings used
- GLP compliance:
- no
Test material
- Reference substance name:
- Trimethoxy(methyl)silane
- EC Number:
- 214-685-0
- EC Name:
- Trimethoxy(methyl)silane
- Cas Number:
- 1185-55-3
- Molecular formula:
- C4H12O3Si
- IUPAC Name:
- trimethoxy(methyl)silane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 24 hour(s)
- Number of animals:
- 6
- Details on study design:
- Six albino rabbits of either sex, weighing from 2.1 to 2.7 kg, were used to evaluate the primary skin irritation of the test material.
The animals were divided into two groups, three with intact and three with abraded skin.
The test material was applied to six one-inch square gauze patches in the amount of 0.5 ml per patch.
The patches were applied to the back of each rabbit, and the patches backed with adhesive tape and covered with a protective tape layer.
After 24-hours the patches were removed and the test sites observed for irritation. The sites were re- examined at 72 hours, the animals weighed
and the study terminated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores were not given in the study report.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores were not given in the study report.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores were not given in the study report.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores were not given in the study report.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores were not given in the study report.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores were not given in the study report.
Any other information on results incl. tables
The average values for erythema and edema obtained from the
three abraded (A) and three intact (I) areas are presented
below:
| 24 hours | 72 hours | ||||
| Erythema | Edema | Erythema | Edema | ||
| Abraded | 1.0 | 0 | 0.33 | 0.33 | |
| Intact | 1.0 | 0 | 0 | 0 |
Based on a PDII of 0.66, this material is considered to be slightly irritating to rabbit skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo skin irritation study, conducted according to a protocol similar to OECD Test Guideline 404 but prior to GLP, trimethoxy(methyl)silane was not irritating to intact skin following 24-hour occluded dermal application.
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