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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
23.09.1996 to 12.12.1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP, and is therefore considered to be reliability 1. Read-across of the result is considered to be reliability 2. Further information on read-across is given in the endpoint summary.

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)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dynasylan CPMDEO (3-chlorpropylmethyldiethoxysilan)
- Substance type: Chloroalkoxysilane
- Physical state: Liquid
- Expiration date of the lot/batch: Six months
- Storage condition of test material: Under inert gas

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:
maize oil
Remarks:
In pretest only
Concentration / amount:
100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
maize 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:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
100
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 100.0. 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
Conclusions:
In a skin sensitisation study (Buehler test) conducted to OECD 406 and to GLP (reliability score 1) (3-chloropropyl)diethoxymethylsilane was not sensitising to the skin of guinea pigs. No local or systemic effects were observed in this study.