Registration Dossier

Administrative data

Description of key information

GPMT (similar to OECD 406): sensitising

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
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
Route:
intradermal and epicutaneous
Vehicle:
other: DOW Corning 344 Fluid
Concentration / amount:
5%
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
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
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In the available key study (Dow Corning Corporation, 1985), the test item was investigated for skin sensitising properties in the Guinea Pig Maximization Test, conducted similar to the OECD TG 406, and in compliance with GLP. 20 Hartley guinea pigs per dose were induced with the test material by receiving 3 pairs of intradermal injections, followed by epicutaneous application of the test material 7 days later. Control animals received the vehicle only during the induction period. Challenge exposure was carried out by epicutaneous application of test item and the vehicle only to both test and control animals. The test material concentrations applied in this test were 5% for intradermal injections and epicutaneous induction, as well as for the challenge exposure. 24 and 48 h after chellenge exposure the animals were examined for skin reactions. None of the negative control animals showed any skin reaction at 24 and 48 h, respectively.In contrast, 9/20 animals (45%) induced with the test material showed skin reactions at both readings. Based on this data, the test material meets the criteria to be classified as a skin sensitiser (Cat 1B, H317) according to EC/1272/2008.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data is reliable and suitable for classification. Based on this data, the registered substance meets the criteria to be classified as a skin sensitiser (Cat 1B, H317) according to EC/1272/2008.