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Toxicological information

Skin sensitisation

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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:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent

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 group
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 group
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.