Registration Dossier
Registration Dossier
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EC number: 219-784-2 | CAS number: 2530-83-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.09.1993 to 05.11.1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Reference substance name:
- [3-(2,3-epoxypropoxy)propyl]trimethoxysilane
- EC Number:
- 219-784-2
- EC Name:
- [3-(2,3-epoxypropoxy)propyl]trimethoxysilane
- Cas Number:
- 2530-83-8
- Molecular formula:
- C9H20O5Si
- IUPAC Name:
- trimethoxy[3-(oxiran-2-ylmethoxy)propyl]silane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33176 Borchen.
- Age at study initiation: 'young'
- Weight at study initiation: <500 g
- Housing: Maximum of five animals per Makrolon type IV cage.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.3°C
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26.09.1993 to 05.11.1993
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test substance.
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test substance.
- No. of animals per dose:
- Pre-test: 3
Main study group: 20
Control group: 10 - Details on study design:
- RANGE FINDING TESTS: 2.5%, 25% and 50% w/w test substance in corn oil MEH 56 and 100% test substance were applied to the skin of three guinea-pigs, under occlusive conditions for six hours. The skin reactions were then assessed 24 and 48 hours after dressing removal. No signs of irritation were observed in any of the animals.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Six hours
- Control group: Treated the same with corn oil MEH 56
- Site: Left flank
- Frequency of applications: On days 0, 7 and 14
- Concentrations: 100% undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 28
- Exposure period: Six hours
- Test groups: 100 % test substance
- Control group: Corn oil MEH 56
- Site: Right flank
- Evaluation (hr after challenge): 24 and 48 hours after dressing removal.
In a separate study, Dunkin-Hartley guinea-pigs were treated with standard allergen 1-chlor-2,4-dinitrbenzol (0.05-0.1 % in vaseline) under the conditions of the Buehler test. They were tested alongside negative controls (vaseline only). This separate study showed the sensitivity of the Buehler test in the laboratory in question. - Challenge controls:
- Negative - corn oil MEH 56
- Positive control substance(s):
- yes
- Remarks:
- 1-chlor-2,4-dinitrobenzol (CDNB; separate investigation)
Results and discussion
- Positive control results:
- Approximately 40-50% of animals gave a positive result.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No effect on body weight gain in control or test animals.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 100 % test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No effect on body weight gain in control or test animals.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 100% vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 100% vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05% 1-chloro-2,4-dinitrobenzol in vaseline
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- No clinical effect observed
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- In an assay to determine the sensitivity of the assay, carried out between 1993-04-25 and 1993-05-27, 50% of animals showed evidence of sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.05% 1-chloro-2,4-dinitrobenzol in vaseline
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- No clinical effects observed
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- In an assay to determine the sensitivity of the assay, carried out between 1993-04-25 and 1993-05-27, 50% of animals showed evidence of sensitisation
Any other information on results incl. tables
There were no substance related effects or influence on body
weight in either test or control animals. There was no
erythema or edema observed during Induction Phase I, II or
III; no skin irritation was observed in the control animals.
There was no skin irritation observed in either test or
control animals in the Challenge Phase.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a well conducted Buehler test (reliability score 1) conducted to OECD 406 and GLP, DYNASYLAN GLYMO (glycidyloxypropyl-trimethoxysilan) was not a skin sensitiser in guinea-pigs.
- Executive summary:
In a well conducted Buehler test (reliability score 1) conducted to OECD 406 and GLP, DYNASYLAN GLYMO (glycidyloxypropyl-trimethoxysilan) was not a skin sensitiser in guinea-pigs.
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