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EC number: 213-914-1 | CAS number: 1066-40-6
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 16.09.1991 to 16.06.1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- ; no info on when sensitivity test was done - OECD 406 states that should be done every 6 months.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation 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:
- Triethoxy(methyl)silane
- EC Number:
- 217-983-9
- EC Name:
- Triethoxy(methyl)silane
- Cas Number:
- 2031-67-6
- Molecular formula:
- C7H18O3Si
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Iffa- Credo (69592 L'Arbresle Cedex - France), Elevage Lebeau (78950 Gambais - France), Interfauna (37600 Loches - France), Charles River France.
- Age at study initiation: 'young' adult
- Weight at study initiation: 300 - 500 g
- Housing: by sex and in groups of five or six (2 for preliminary studies), in polystyrene cages with perforated flooring.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16.09.1991 to 16.06.1992
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sterile Codex liquid paraffin
- Concentration / amount:
- Induction: 25%
Challenge: 10%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sterile Codex liquid paraffin
- Concentration / amount:
- Induction: 25%
Challenge: 10%
- No. of animals per dose:
- Preliminary studies (minimum of 3): 2 males, 2 non-pregnant females, per study.
Main study: Control group: 10 males, 10 non-pregnant females.
Treated group: 10 males, 10 non-pregnant females. Two extra guinea pigs (1/sex) treated to allow for any possible non-treatment-related deaths. - Details on study design:
- RANGE FINDING TESTS: 0.1 mL intradermal injection of 50, 25 and 10% was administered to the dorsal region in order to determine the concentration that will provoke a weak to moderate irritation and which is not toxic. The skin was evaluated at each concentration at 24 and 48 hours after the injections, according to the scale of Magnusson and Kligman. For the topical application a 48 hour occlusive patch test was performed with 50 and 25%. The aim of the topical applications is to determine the concentration that will provoke a weak to moderate irritation and which is non-toxic. The skin was evaluated at each concentration at 24 and 48 hours after the injections, according to the scale of Magnusson and Kligman.
To determine the challenge concentration a 0.5 mL topical application of the test substance was applied using a 24 hour occlusive patch test in order to determine the maximum non-irritating concentration. The treated skin was evaluated at 24 and 48 hours after removal of the patches according to the above mentioned scale.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two (one intradermal on Day 1 and one topical on Day 9)
- Exposure period: Topical application was for 48 hours
- Test groups: Intradermal: 3 series of 2 x 0.1 mL injections: 1) Freund's complete adjuvant at 50% (v/v) in an isotonic injectable solution; 2) test substance in a 25% (v/v) solution in Sterile Codex liquid paraffin; 3) mixture 50/50 (v/v): test substance in a 50% (v/v) solution in Sterile Codex liquid paraffin + Freund's complete adjuvant at 50% (v/v) in an isotonic injectable solution, i.e. a final 25% concentration of the test substance.
Topical occlusive: 0.5 mL of the test substance in a 50% (v/v) solution in Sterile Codex liquid paraffin.
- Control group: The intradermal injections and the topical occlusive application for 48 hours were conducted under the same conditions as in the treated group, Sterile Codex liquid paraffin replacing the test substance.
- Site: clipped dorsal shoulder region
- Concentrations: 25% solution (weak to moderate irritation in preliminary study)
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Following 11 days 'rest period' the challenge phase was initiated on Day 22.
- Exposure period: 24 hours
- Test and control groups: Topical occlusive application for 24 hours was performed in the treated and control group with the test substance in a 10% (v/v) solution in Sterile Codex liquid paraffin and at a rate of 0.5 mL.
- Site: Clipped and shaved flank
- Concentrations: 10% (maximum non-irritating concentration)
- Evaluation (hr after challenge): 24 and 48
OTHER: Histopathological examinations of the skin were performed for three animals of the treated group which showed doubtful macroscopic reactions at 48 hours. - Challenge controls:
- Vehicle challenge
- Positive control substance(s):
- no
- Remarks:
- Sensitivity test conducted (no date)
Study design: in vivo (LLNA)
- Statistics:
- None required
Results and discussion
- Positive control results:
- No positive controls. However, it appears that the laboratory had conducted the same protocol with reference substances to show the sensitivity of their methodology.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% TS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema or edema in any animal. Mild desquamation at test substance site at 24 and 48 hour readings (observed in more males than females).
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 % TS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema or edema in any animal. Mild desquamation at test substance site at 24 and 48 hour readings (observed in more males than females).
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% TS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema and edema in any animal. Desquamation in one animal.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema/edema in males, Grade 1 erythema/edema in three females, where subsequent histopathology revealed no signs of cell mediated delayed hypersensitivity. 7/10 males and 4/10 females showed desquamation (including the three with erythema/edema).
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Signs of irritation were noted during the induction. Although macroscopic examination showed grade 1 erythema/edema in 3 females 48 h after challenge subsequent histopathological examinations did not reveal any lesion of delayed hypersensitivity in the those animals. No noticeable cutaneous abnormality was noted in the 20 guinea pigs examined in the control group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Guinea pig Maximisation Test conducted to GLP and OECD 406 (reliability score 1) triethoxy(methyl)silane was not sensitising to the skin.
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