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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:
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:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent

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 group
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 group
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 group
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.