Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 214-685-0 | CAS number: 1185-55-3
Endpoint summary
Administrative data
Description of key information
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 (Hazelton Laboratories, 1966).
In an in vivo eye irritation study conducted according to OECD Test Guideline 405 and in compliance with GLP, trimethoxy(methyl)silane was non-irritant to rabbit eyes (Hoechst, 1991).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressings used
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- 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. - 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.
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.10.1991 to 18.10.1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.1 - 3.9 kg
- Housing:
- Diet: Altromin 2123 ad libitum
- Water: deionised tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 55 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: Neat - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein (0.01% ) - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Mild to moderate conjunctival redness and discharge were observed in all test animals 1 hour post-instillation. Mild chemosis was also observed at this time point. All effects were fully resolved by the 24-hour observation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo eye irritation study conducted according to OECD Test Guideline 405 and in compliance with GLP, trimethoxy(methyl)silane was non-irritant to rabbit eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the key in vivo skin irritation study (Hazelton Laboratories, 1966), 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.
A second study on skin irritation is also available, (Mellon Institute, 1963) in which the results were consistent with the key study.
The key study for eye irritation found the test material non-irritating to the eyes of rabbits, in a study conducted in accordance with OECD 405 and in compliance with GLP (Hoechst, 1991). Mild to moderate conjunctival redness and discharge were observed in all test animals 1-hour post-instillation. Mild chemosis was also observed at this time point. All effects were fully resolved by the 24-hour observation.
A supporting study by the Mellon Institute (1963) was also available, reporting Grade 2 corneal necrosis determined according to a protocol which was lacking in detail on the study conduct, and was not compliant with GLP, using an excess amount of test material.
A second supporting study found the test substance slightly irritating in a reliable study conducted according to an appropriate test protocol, but not compliant with GLP (Hazelton Laboratories, 1966). The observed effects do not meet the criteria for classification as an eye irritant.
Finally, a reliability 4 supporting study was also available which found the test material slightly irritating, but which does not meet current guideline requirements (Laboratoires de Recherches de la Societe des Usines Chimiques Rhone-Poulenc, 1972). The result does, however, add to the weight of evidence for eye irritation. The observed effects do not meet the criteria for classification as an eye irritant in the EU.
Justification for classification or non-classification
Based on the available data trimethoxy(methyl)silane does not require classification for irritation according to Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
