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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Sep 1991 - 16 Jun 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline, and in compliance with GLP. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
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:
The test was performed in 1992 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods.“

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethoxy(methyl)silane
EC Number:
217-983-9
EC Name:
Triethoxy(methyl)silane
Cas Number:
2031-67-6
Molecular formula:
C7H18O3Si
IUPAC Name:
triethoxy(methyl)silane
Details on test material:
- Name of test material (as cited in study report): Silan M1-triethoxy
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: Not clear, but stated that administered within 4 hours of preparation
- Storage condition of test material: About 4oC, in the dark and away from humidity

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: Ad libitum
- Water: Ad libitum
- Acclimation period: At least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16 Sep 1991 to 16 Jun 1992

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: Sterile Codex liquid paraffin
Concentration / amount:
intradermal induction: 25%
topical induction: 50%
Day(s)/duration:
48 hr for topical exposure
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Sterile Codex liquid paraffin
Concentration / amount:
10%
Day(s)/duration:
24 hr
No. of animals per dose:
20 (test group), 20 (control group)
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 Klingman. 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: (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal: (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/ isotonic injectable solution
Injection 2: test substance in a 25% (v/v) solution in Sterile Codex liquid paraffin
Injection 3: test substance in a 1:1 mixture (v/v) FCA/ isotonic injectable solution
Epicutaneous: test substance in a solution in Sterile Codex liquid paraffin
- Control group:
Intradermal: (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/ isotonic injectable solution
Injection 2: Sterile Codex liquid paraffin
Injection 3: Sterile Codex liquid paraffin at 50% (v/v) in a 1:1 mixture (v/v) FCA/ isotonic injectable solution
Epicutaneous: Sterile Codex liquid paraffin
- Site: dorsal shoulder region
- Frequency of applications: every 7 days
- Duration: Example: Days 0-8
- Concentrations: 25% solution (weak to moderate irritation in preliminary study)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test and control groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: clipped and shaved flank
- Concentrations: 10% - Evaluation (hr after challenge): 24 and 48 h

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:
The control group is actually a challenge control.
Positive control substance(s):
no
Remarks:
Sensitivity test conducted (no date)

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
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%; challenge: 10%
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).
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%; challenge: 10%
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).
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction: 25%; challenge: 10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No erythema and edema in any animal. Desquamation in one animal.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction: 25%; challenge: 10%
No. with + reactions:
3
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).
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
but referred to regular positive testing in the laboratory

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:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
Conclusions:
In a guinea pig skin sensitisation study (guinea pig maximisation test) conducted to OECD 406 and to GLP the test material did not induce any skin sensitization in any of the animals tested at any time point. There were no clinical signs of systemic toxicity.