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Registration Dossier
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EC number: 402-140-1 | CAS number: 17865-32-6 CHMMS; CHMS; DYNASYLAN 9407; Z-6187
Endpoint summary
Administrative data
Description of key information
In an acute dermal irritation
study conducted according to OECD Test Guideline 404 and in compliance
with GLP (Safepharm Laboratories Ltd., 1995c)
cyclohexyl(dimethoxy)methylsilane was concluded to be irritating to the
skin of rabbits, based on persistent, widespread erythema and oedema,
with desquamation in all three animals. The irritation was reversible.
In an eye irritation study conducted according to OECD Test Guideline 405 and in compliance with GLP (Safepharm Laboratories Ltd., 1995d) cyclohexyl(dimethoxy)methylsilane was concluded to be not irritating to the eyes of rabbits.
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:
- 30.06.1995 to 14.07.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.38-2.89 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 49-74
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30.06.1995 To: 14.07.1995 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- 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:
- 14 days (approximately 1, and 24, 48 and 72 hours, and 7 and 14 days after removal of patches)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal flank
- % coverage: No data
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, residual test substance removed by gentle swabbing with cotton wool soaked in 74% Industrial methylated spirits
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7-14 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Sum of 24 and 72-hour reading
- Score:
- 4.3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 7-14 days
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Well-defined erythema and slight to moderate oedema were noted at all treated skin sites one hour after patch removal and at the 24, 48 and 72-hour observations. The erythema extended up to 3 cm beyond one treatment site at the one hour observation and up to 6 cm beyond the remaining treatment sites at the 24, 48 and 72 hour observations.
- Other effects:
- Crust formation was noted at all treated skin sites at the 7-day observation. Crust formation prevented accurate evaluation of erythema at one treated skin site at this time. Desquamation was noted at all treated skin sites 14 days after treatment. This reaction was considered to be reversible.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal irritation study conducted to OECD Test Guideline 404 and in compliance with GLP (reliability score 1) cyclohexyldimethoxymethylsilane was irritating to the skin of rabbits under semi-occlusive conditions, based on persistent, widespread erythema and oedema, with desquamation in all three animals. The irritation was reversible.
Reference
Table 1 Summary of individual irritation scores
| Skin reaction | Observation time | Scores | ||
| Animal 1 | Animal 2 | Animal 3 | ||
| Erythema | 1 hour | 2R | 2 | 2 |
| 24 hours | 2R | 2R | 2 | |
| 48 hours | 2R | 2R | 2 | |
| 72 hours | 2R | 2R | 2 | |
| 7 days | ?eCf | 0Cf | 0Cf | |
| 14 days | 0D | 0D | 0D | |
| Oedema | 1 hour | 3 | 2 | 2 |
| 24 hours | 3 | 2 | 2 | |
| 48 hours | 3 | 2 | 2 | |
| 72 hours | 3 | 2 | 2 | |
| 7 days | 0 | 0 | 0 | |
| 14 days | 0 | 0 | 0 | |
D= desquamation
R= reaction extending up to 3 to 6 cm beyond treatment site
Cf= crust formation
?e= adverse reactions prevent accurate evaluation of erythema
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 05.07.1995 to 09.07.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEc, Method B5
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.7-2.92 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 49-68
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05.07.1995 To: 09.07.1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- N/A
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- One initially, then an additional two
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: examination was facilitated using the light source from a standard ophthalmoscope - 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
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- 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:
- conjunctivae score
- Remarks:
- (redness)
- 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 #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
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- 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:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal effects noted. Iridial inflammation noted in one treated eye at 24 hours, but no other iridial effects noted. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation. Minimal conjunctival redness persisted in one treated eye at the 48-hour observation. Changes fully reversible within 72 hours.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an eye irritation study conducted according to OECD Test Guideline 405 and in compliance with GLP (reliability score 1) cyclohexyldimethoxymethylsilane was not irritating to the eyes of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
There are several reliable studies that address the skin and eye irritation endpoints. The most recent of these were selected as the key studies. The other available studies provide valuable supporting data.
In the case of skin irritation, two of the studies showed cyclohexyl(dimethoxy)methylsilane to be irritating to the skin of the rabbits tested, and it is these two studies that the classification is based on.
All three of the eye irritation studies were negative.
Justification for classification or non-classification
Based on the available in vivo data, cyclohexyl(dimethoxy)methylsilane is classified skin irritant Category 2, with the hazard statement 'H315: Causes skin irritation' and is not classified eye irritant, according to the criteria of 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.
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