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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
refer to analogue report provided in IUCLID section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The test was performed in 2000 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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): A-1160 (methanol stripped)
- Physical state: clear, colourless liquid
- Substance type: Alkoxysilane
- Storage condition of test material: At room temperature in the dark under nitrogen

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan strain, albino guinea pig
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Biotechnology and animal breeding division (RCC Ltd.), Fuellinsdorf, Switzerland
- Age at study initiation: approx. 4 weeks
- Weight at study initiation: 294 ± 14 g (control group), 308 ± 16 g (experimental group)
- Housing: 5 animals per metal cage
- Diet: standard guinea pig diet including ascorbic acid (1000 mg/kg) (Charles River breeding and maintenance diet for guinea pigs, Altromin, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml (100%)
Day(s)/duration:
1-15
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml (100%)
Day(s)/duration:
28
Adequacy of challenge:
other: undiluted test substance
No. of animals per dose:
Control group: 10 animals
Experimental group: 20 animals
Details on study design:
RANGE FINDING TESTS:
In a range finding test the application of undiluted test substance to 2 animals did not reveal any erythema or edema findings 24 and 48 h after exposure.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (day 1, 8, and 15)
- Exposure period: 6 h
- Test groups: 0.5 ml undiluted test substance (100%)
- Control group: 0.5 ml water
- Site: left side of the scapular region
- Frequency of applications: every 7 days
- Duration: day 1-15
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: 0.15 ml (100%) test substance + 0.15 mL water
- Control group: 0.15 ml (100%) test substance + 0.15 mL water
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamic aldehye

Results and discussion

Positive control results:
No positive control was used with this study, but data are available showing that a reliability check is carried out at regular intervals at least every six months. The positive control substance (alpha-hexylcinnamic aldehyde) was used for a reliability check, and induced positive reactions in 60% of the animals, thus meeting the reliability criteria for the Buehler test (=15% positive response).

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%, challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Induction: 100%, challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%, challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
Induction: 100%, challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects observed
Group:
positive control
Remarks on result:
positive indication of skin sensitisation

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 Buehler Test conducted to GLP and OECD 406 the test material was not sensitising to the skin.