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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:
other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

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

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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% test substance.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% test substance.
No. of animals per dose:
Pretest: 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)

Results
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:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 100% test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No effect on body weight gain in control or test animals. .

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:
not sensitising
Remarks:
Migrated information
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.