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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation (OECD 406), GPMT: not 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
Study period:
06 - 30 Mar 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study conducted according to the appropriate OECD test guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
no information on periodically reliability checks is reported
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed in 1990 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods".“
Species:
guinea pig
Strain:
other: Albino (Bor: DHPW)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 393 g (mean test group), 395 g (mean control group)
- Housing: Animals were housed in groups of 1 - 5 in Makrolon cages (type IV)
- Diet: G4 diet for guinea pigs (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 - 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
5 and 100%
Day(s)/duration:
0-14
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
corn oil
Concentration / amount:
100%
Day(s)/duration:
22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 (test group), 10 (control group)
Details on study design:
RANGE FINDING TESTS:
No detailed information on a range finding test is reported. The neat test material (100%) did not induce any skin reactions in the range finding test. Thus, animals were treated with 10% SDS (in vaseline) one day prior to epicutaneous application with the test material (induction phase).

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: 5% test substance in water (v/v)
Injection 3: 5% test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: 100% test substance

- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: corn oil
Injection 3: corn oil at 50% (v/v) in a 1:1 mixture (v/v) FCA/water
Epicutaneous: corn oil
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 5%, epicutaneous 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day(s) of challenge: 22 (challenge)
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: left flank (test substance and vehicle)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
no
Positive control results:
No information on periodically reliability checks reported.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%; challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
neither erythema nor edema observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction: 5 and 100%; challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
neither erythema nor edema observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%; challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
neither erythema nor edema observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction: 5 and 100%; challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
neither erythema nor edema observed
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In a GPMT according to OECD guideline 406, the test item was not sensitising. Induction (intradermal: 5%; topical: 100%) and challenge (100%) with the test item revealed no skin reactions in any of the 20 animals. Furthermore no skin reactions were observed in the negative controls (induction with corn oil, topical challenge with 100% test item).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Skin sensitisation

The skin sensitising properties of N-methyl-3-(trimethoxysilyl)propylamine (CAS 3069-25-8) were tested in a study according to OECD TG 406 using the Guinea pig maximization test (GPMT, Hüls AG, 1990). The GPMT test was performed on 20 female Albino (Bor: DHPW) guinea pigs. At the beginning of the induction exposure 20 test animals and 10 control animals were either intradermally treated with 5% of the test substance or vehicle (corn oil), followed by SDS treatment for induction of local irritation and topical induction (100% or vehicle) under occlusive conditions one week later. On Day 22 all animals were challenged with the test substance at a concentration of 100%. Skin reactions of all animals were evaluated 24 and 48 hours after challenge exposure (after removal of the patch). No skin reactions were observed at any animal neither in the control nor in the test group. No information on periodically reliability checks were reported. In conclusion, under the conditions of the test, the test substance revealed no skin sensitising properties.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

The available data on skin sensitisation of N-methyl-3-(trimethoxysilyl)propylamine do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.