Registration Dossier
Registration Dossier
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EC number: 232-136-3 | CAS number: 7787-93-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-11-18 to 1998-04-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 substance name:
- Dichloro(3-chloropropyl)methylsilane
- EC Number:
- 232-136-3
- EC Name:
- Dichloro(3-chloropropyl)methylsilane
- Cas Number:
- 7787-93-1
- Molecular formula:
- C4H9Cl3Si
- IUPAC Name:
- dichloro(3-chloropropyl)methylsilane
Constituent 1
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, Borchen, GERMANY
- Age at study initiation: young adults (no further details)
- Weight at study initiation: lest than 500 g (no further details)
- Housing: 5/Makrolon type IV cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: main study From: 1998-03-18 To: 1998- 04-17
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- induction: 2.5% (causing moderate to intense skin irritatin in the preliminary study)
challenge: 1% (the highest non-irritating concentration)
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- induction: 2.5% (causing moderate to intense skin irritatin in the preliminary study)
challenge: 1% (the highest non-irritating concentration)
- No. of animals per dose:
- 20 treated
10 control
9 premilinary range-finding study - Details on study design:
- RANGE FINDING TESTS: 6 animals tested at 0.5-50%. A further 3 animals used to determine challenge concentration.
INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test group: 20
- Negative control group: 10
- Site: left flank
- Frequency of applications: days 0, 7, 14
- Duration: induction period continues to day 14
- Concentration: test group 2.5% in corn oil; control group corn oil
- Reliability check (+ve control): 20 treated and 10 control animals; induction with neat alpha-cinnamaldehyde
CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 28
- Exposure period: 6h
- Test group: 20
- Negative control group: 10
- Site: right flank
- Concentration: test and control groups 1% in corn oil
- Reliability check (+ve control): 20 treated and 10 control animals; challenge with 50% alpha-cinnamaldehyde in corn oil - Challenge controls:
- Negative (vehicle): corn oil
Positive (reliability check): alpha-cinnamaldehyde - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Delayed contact hypersensitivity identified in 50%, tested 24-11-1997 to 24-12-1997.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- HCA
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- HCA
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table 1: Incidence of dermal response to challenge dosing
GROUP |
MATERIAL |
INTERVAL |
Number with skin reaction |
SENSITIZATION INCIDENCE INDEX |
|
||||
Test |
TS 1% |
24h |
0/20 |
0/20 |
48h |
0/20 |
0/20 |
||
Vehicle control |
TS 1% |
24h |
0/10 |
0/10 |
48h |
0/10 |
0/10 |
||
Positive control |
alpha-HCA 50% |
24h |
10/20 |
10/20 |
48h |
9/20 |
9/20 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A well conducted, well reported guinea-pig skin sensitization test (Buehler Method) reported that a 2.5% concentration of the test material in corn oil failed to induce a sensitization response in guinea pigs when challenged with a 1% solution. Appropriate negative and positive compliance controls data were provided.
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