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Description of key information

There are no skin sensitisation data for 3-chloropropyl(dimethoxy)methylsilane. Therefore, data have been read across from the structurally related 3-chloropropyl(diethoxy)methylsilane.

In a skin sensitisation study (Buehler test) conducted to OECD 406 and to GLP (Hüls AG, 1997e) 3-chloropropyl(diethoxy)methylsilane was not sensitising to the skin of guinea pigs. No local or systemic effects were observed in this study.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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.
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
Route:
epicutaneous, occlusive
Vehicle:
other: maize oil / in pre-test only
Concentration / amount:
100%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: maize oil / in pre-test 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.
Positive control results:
Positive results were presented for a standard allergen, the identity of which was not included in the report.
Key result
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:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
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:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: Positive results were presented for a standard allergen, the identity of which was not included in the report.

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

Interpretation of results:
GHS criteria not met
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no skin sensitisation data for 3-chloropropyl(dimethoxy)methylsilane. Therefore, data have been read across from the structurally related 3-chloropropyl(diethoxy)methylsilane. The key study was conducted according to OECD 406 and in compliance to GLP and was the only skin sensitisation study available for the source substance. The test substance was not sensitising to guinea pig skin (Huls AG, 1997b).

At induction, 100% of the test substance in maize oil vehicle was applied to the left flank region of the animals (day 0). This application process was repeated in total three times (day 7 and 14). The undiluted test substance was applied epicutaneously to the same area for 6 h.

At challenge, on day 28 (two weeks after the last topical induction application), 100 % of the test substance in maize oil as the vehicle, was applied to the right flank region for 6 h. Evaluation of sensitisation occurred 24 and 48 h after patch removal. No local or systemic effects were observed and no irritation was observed in any of the animals during the three induction phases or the challenge phase.

Skin sensitisation data on the analogue substances, 3-chloropropyl(trimethoxy)silane (Evonik Degussa, 1993) and 3-chloropropyl(triethoxy)silane (DCC, 1995), have been included in support of the analogue group approach taken for this substance.

See Section 13 of IUCLID for the read-across justification reports.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on read across data from 3-chloropropyl(diethoxy)methylsilane, 3-chloropropyl(dimethoxy)methylsilane is not classified as a skin sensitiser according to Regulation (EC) No 1272/2008.