Registration Dossier
Registration Dossier
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EC number: 245-642-4 | CAS number: 23410-40-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study was performed before LLNA method was first choice method
Test material
- Reference substance name:
- N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine
- EC Number:
- 245-642-4
- EC Name:
- N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine
- Cas Number:
- 23410-40-4
- Molecular formula:
- C9H24N2O2Si
- IUPAC Name:
- N-{3-[dimethoxy(methyl)silyl]-2-methylpropyl}ethane-1,2-diamine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory
- Age at study initiation:
- Weight at study initiation: approximately 350 g
- Housing: individually in stainless steel cages
- Diet: standard PURINA guinea pig chow, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: 7 days
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: DOW Corning 344 Fluid
- Concentration / amount:
- 5%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: DOW Corning 344 Fluid
- Concentration / amount:
- 5%
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: test substance in DOW Corning 344 fluid
Injection 3: test substance in a 1:1 mixture (v/v) FCA
Epicutaneous: test substance in DOW Corning 344 fluid
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: DOW Corning 344 fluid
Injection 3: DOW Corning 344 fluid in a 1:1 mixture (v/v) FCA
Epicutaneous: test substance in DOW Corning 344 fluid
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: days 0-7
- Concentrations: intradermal 5%, epicutaneous 5%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: right flank (test substance) and left flank (vehicle)
- Concentrations: 5%
- Evaluation (hr after challenge): 24 h and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are met, Category 1B classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a GPMT conducted to GLP and OECD 406 (reliability score 1) N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine was sensitising to the skin.
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