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Diss Factsheets

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:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
no
GLP compliance:
yes (incl. QA statement)
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

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(2-butoxyethyl) orthosilicate
EC Number:
242-560-0
EC Name:
Tetrakis(2-butoxyethyl) orthosilicate
Cas Number:
18765-38-3
Molecular formula:
C24H52O8Si
IUPAC Name:
tetrakis(2-butoxyethyl) orthosilicate
Details on test material:
- Name of test material (as cited in study report): Dynasil BG
- Substance type: Organosilane
- Physical state: Liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann
- Age at study initiation: no data
- Weight at study initiation: 429-491 g
- Housing: no data
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction phase 1: neat
Induction phase 2 (day 7): neat
Induction phase 3 (day 14): 50% in corn oil
Challenge: 50% in corn oil
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction phase 1: neat
Induction phase 2 (day 7): neat
Induction phase 3 (day 14): 50% in corn oil
Challenge: 50% in corn oil
No. of animals per dose:
Ten
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Six hours
- Test groups: test substance only
- Control group: Corn oil
- Site: Left flank
- Frequency of applications: 0, 7 and 14 days
- Concentrations: neat


B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 28
- Exposure period: Six hours
- Control group: Corn oil
- Site: Right flank
- Concentrations: 50% in corn oil
- Evaluation (hr after challenge): 24, 48 and 72
Challenge controls:
Corn oil negative controls only
Positive control substance(s):
not required

Results and discussion

Positive control results:
No positive controls

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
12
Group:
test chemical
Dose level:
50% in corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical observations
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% in corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical observations
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50% in corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical observations
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
corn oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
corn oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: positive control readings were not included

Any other information on results incl. tables

In induction phase 1, no skin reactions were evident at six hours post-exposure, but by 24 hours 3/10 animals had grade 1 erythema, and no oedema. In induction phase 2, there were no skin reactions by six hours, but by 24 hours 4/10 and 3/10 animals had grade 1 erythema and oedema, respectively. In phase 3 induction, 4/10 animals had erythema and 2/10 animals had oedema by six hours, but there was no evidence of a reaction by 24 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was not sensitising to the skin of guinea-pigs under the conditions of this good quality OECD 406 study, conducted to GLP.
Executive summary:

Ten test and ten control (corn oil only) Dunkin-Hartley guinea-pigs were used in this OECD 406 Buehler test. Following three six-hour induction phases (using 100% test material in phases 1 and 2, and 50% in corn oil in phase 3) on the left flanks of the animals, the challenge phase involved a six-hour induction phase on the right flanks of the animals. During the induction phases there was mild irritation in some animals. None of the guinea-pigs showed any skin reactions in the challenge phase and hence the substance was concluded not to be a skin sensitiser.