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Description of key information

1-Methyl-N,N',N''-tris(1-methylpropyl)silanetriaminel is reported to not be sensitising to guinea pig skin in the study, conducted according to OECD TG 406 and in compliance with GLP (Hazleton, 1990).

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:
1988-08-05 to 1990-04-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Information regarding positive control group not included in the report.
GLP compliance:
yes
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.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Lebeau, France
- Age at study initiation: young adults
- Weight at study initiation: 341 - 500 g
- Housing: housed by sex in groups of 5 or 6 in polystyrene cages
- Diet: complete pelleted guinea-pig maintenance diet, ad libitum
- Water: filtered and softened drinking water, ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 27.5
- Humidity (%): 23 - 83
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Route:
epicutaneous, occlusive
Vehicle:
other: sterile Codex liquid paraffine
Concentration / amount:
Range finder: Undiluted, 25%, 10%, 5% and 1%

Test group:
Induction - 1 %
Challenge - 1 %
0.5 ml of the test article in 1 % (W/W) solution in sterile Codex liquid paraffin.
Negative control group: 0.5 ml per animal of sterile Codex liquid paraffin.
Positive control group: not included in the study
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: sterile Codex liquid paraffin
Concentration / amount:
Range finder: Undiluted, 25%, 10%, 5% and 1%

Test group:
Induction - 1 %
Challenge - 1 %
0.5 ml of the test article in 1 % (W/W) solution in sterile Codex liquid paraffin.
Negative control group: 0.5 ml per animal of sterile Codex liquid paraffin.
Positive control group: not included in the study
No. of animals per dose:
Test group: 10 (+1) males, 10 (+1) females
Control group: 10 males, 10 females
Details on study design:
RANGE FINDING TESTS:

PRELIMINARY STUDY:

The test material was applied undiluted, then in 25 %, 10 %, 5 % and 1 % (w/w) solution in sterile Codex liquid paraffin to guinea-pig skin. When undiluted, total necrosis of the application site was observed in the 4 treated animals. When 25 % solution of the test material was applied to the skin, moderate irritation and less than a quarter burnt aspect of the application site was observed in 3 out of 4 animals. Following 10 % solution application, erythema was noted in 3 out of 4 guinea-pigs. When 5 % solution was applied to the skin, less than a quarter of the area was burnt in 1 out 4 animals with no evidence of erythema or oedema. Following 1 % solution of the test material in sterile Codex liquid paraffin, no cutaneous abnormality was observed.

MAIN STUDY

A. INDUCTION EXPOSURE

The left lateral abdominal region was clipped and shaved. The test material and the vehicle (sterile Codex liquid paraffin) were applied at days 1, 8 and 15. 0.5 ml of sterile Codex liquid paraffin was applied to the control group and 0.5 ml in 1 % (W/W) sterile Codex liquid paraffin was applied to the treated group. An occlusive dressing kept the test material/vehicle in contact with the skin. The exposure period was 6 hours. The animals were not subject to treatment from day 15 until day 29 from the study period.

B. CHALLENGE EXPOSURE

The application area was clipped and then shaved. 0.5 ml of the test material in 1 % (W/W) sterile Codex liquid paraffin was applied to the posterior flank of the abdominal region and 0.5 ml of sterile Codex paraffin was applied to the anterior flank of the abdominal region. The test material was applied at day 29 from the study period. The test material and the vehicle were both kept with an occlusive patch for 6 hours onto the skin.
Challenge controls:
0.5 ml per animal of sterile Codex liquid paraffin.
Positive control substance(s):
no
Positive control results:
No positive control data.
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:
negative control
Dose level:
0.5 ml of sterile Codex liquid paraffin
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:
negative control
Dose level:
0.5 ml of sterile Codex liquid paraffin
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:
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:
negative control
Dose level:
0.5 ml sterile Codex liquid paraffin
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:
negative control
Dose level:
0.5 ml sterile Codex liquid paraffin
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Two females were found dead at 1 day and 1 month after the 'challenge' application. No clinical sings were observed after necropsy. Both animals were replaced by guinea-pigs from the complementary group. No other clinical changes were observed.

Slight increase in the body weight was observed during the study period.

Interpretation of results:
GHS criteria not met
Conclusions:
1-Methyl-N,N',N''-tris(1-methylpropyl)silanetriamine is reported to be not sensitising to guinea pig skin in the study, conducted according to OECD TG 406 and in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a skin sensitisation Buehler test conducted according to OECD 406 and in compliance with GLP (Hazleton, 1990), using albino Dunkin-Hartley guinea pigs, 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine was applied in three induction applications and a challenge application (0.5ml, 1% w/w in sterile codex liquid paraffin, posterior flank, 10 animals/sex). The negative control group had three induction applications to sterile codex liquid paraffin only, followed by a challenge application of 1-methyl-N,N',N''-tris(1 -methylpropyl)silanetriamine (0.5 ml, 1% w/w in sterile codex liquid paraffin, posterior flank, 10 animals/sex). Sterile codex liquid paraffin was also applied to the anterior flank of all animals during the challenge phase. Macroscopic examinations of the skin were conducted 24 and 48 hours after challenge applications were completed. Reactions were graded according to the Draize scale. No cutaneous reactions were observed in treated or control animals. Therefore, it was concluded that the test substance was not sensitising to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available in vivo data, 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine, is not classified as sensitising to skin according to Regulation (EC) 1272/2008.

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