Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23.09.1996 to 12.12.1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen
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
- Age at study initiation: 'adult'
- Weight at study initiation: 500 g
- Housing: Maximum of 5 animals in Makrolon Type IV cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23.09.1996 to 12.12.1996

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Remarks:
In pretest only
Concentration / amount:
100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Remarks:
In pretest only
Concentration / amount:
100%
No. of animals per dose:
Pretest: 3
Main test: 20
Main control: 10
Details on study design:
RANGE FINDING TESTS: The undiluted test substance was determined to be the highest non-irritating concentration. Therefore the test substance was applied undiluted in the induction and challenge phases.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three
- Exposure period: six hours
- Site: Flank regions (left)
- Frequency of applications: Day 0, day 7 and day 14
- Concentrations: 100 %


B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 28
- Exposure period: six hours
- Site: right flank
- Concentrations: 100 %
- Evaluation (hr after challenge): 24 and 48 hours after patch removal.
Challenge controls:
Test substance applied to animals exposed to vehicle only in induction phases.
Positive control substance(s):
yes
Remarks:
Results with a standard allergen are presented, but the identity of the allergen does not appear to have been included.

Study design: in vivo (LLNA)

Statistics:
None required.

Results and discussion

Positive control results:
Positive results were presented for a standard allergen, the identity of which was not included in the report.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No clinical observations or effects on body weight gain.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No clinical observations or effects on body weight gain. .
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Any other information on results incl. tables

No irritation was observed in any of the animals during the three induction phases or the challenge phase.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a skin sensitisation study (Buehler test) conducted according to OECD 406 and to GLP, (3-chloropropyl)diethoxymethylsilane was not sensitising to the skin of guinea pigs. No local or systemic effects were observed in this study.