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Diss Factsheets

Administrative data

Description of key information

The key skin sensitisation study for 1,3,5-tris[3-(trimethoxysilyl)propyl]-1,3,5-triazinane-2,4,6-trione reports that the test material is not sensitising to the skin of guinea pig. The study was conducted according to OECD TG 406 and in compliance with GLP ( BSL Bioservice, 2016).

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:
2015-11-04 to 2016-01-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
An LLNA study was not performed because the 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:
other: Crl: HA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: approximately 4 weeks old
- Weight at study initiation: 311-366 g
- Housing: kept in groups in Terluran cages
- Diet: autoclaved hay and to Altromin 3122 maintenance diet for guinea pigs, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12/ 12

Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction I, II and III: 0.5ml of 100 % test material
Challenge: 0.5 ml of 100 % test material
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction I, II and III: 0.5ml of 100 % test material
Challenge: 0.5 ml of 100 % test material
No. of animals per dose:
test group: 20 animals
negative control group: 10 animals
Details on study design:
RANGE FINDING TESTS: 2 animals were treated topically with 0.5 ml of 100% and 75% of the test item (diluted with cottonseed oil) for 6 hours. The patch was applied to the test area of approximately 2.5 x 2.5 cm and was held in contact with the help of an occlusive dressing for 6 hours.

MAIN STUDY
A. INDUCTION EXPOSURE
The hair on the left flank was clipped prior to the first, second and third exposure.
Test group: 0.5 ml of the test material was applied to approximately 2.5 x 2.5 cm area and held in contact to the skin by occlusive dressing for 6 hours. The procedure was repeated once a week on the same test area at weekly intervals for 3 weeks.
Negative control group: a dry patch was applied to the test area of approximately 2.5 x 2.5 cm and held in contact to the skin under occlusive dressing for 6 hours. The procedure was repeated once a week on the same test area at weekly intervals for 3 weeks.

B. CHALLENGE EXPOSURE
The hair was clipped from both flanks prior to treatment.
Test group: 14 days after the last induction 0.5 ml of the test substance was applied to an area of approximately 2.5 x 2.5 cm on the right flank and held under occlusive dressing for 6 hours.
Negative control group: 14 days after the last induction dry patch was applied to an area of approximately 2.5 x 2.5 cm on the left flank and held under occlusive dressing for 6 hours.
Challenge controls:
10 guinea pigs
Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole
Positive control results:
The sensitisation rate after application of the positive-control substance mercaptobenzothiazole (25% in vaseline) was 85%, confirming the reliability of the test system.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
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:
100 %
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 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Dose level:
mercaptobenzothiazole (25% in vaseline)
Remarks on result:
other: The sensitisation rate after application of the positive-control substance mercaptobenzothiazole (25% in vaseline) was 85%
Interpretation of results:
GHS criteria not met
Conclusions:
The skin sensitisation study for tris[3-(trimethoxysilyl)propyl]-1,3,5-triazinane-2,4,6-trione reports that the test material is not sensitising to the skin of guinea pig. The study was conducted according to OECD TG 406 and in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The key skin sensitisation study for 1,3,5-tris[3-(trimethoxysilyl)propyl]-1,3,5-triazinane-2,4,6-trione reports that the test material is not sensitising to the skin of guinea pig. The study was conducted according to OECD TG 406 and in compliance with GLP ( BSL Bioservice, 2016).

For the induction exposure, 0.5 ml of 100 % of the test material was applied onto the skin of 20 guinea pigs for 6 hours under an occlusive patch. The procedure was repeated once a week at the same test area at weekly intervals for 3 weeks. No signs of irritation were observed in any of the animals immediately after removal of the test material or at 24 hours post-application.

For the challenge exposure, 0.5 ml of 100 % of the test material was applied onto the skin of 20 guinea pigs for 6 hours under occlusive patch. No signs of erythema or oedema were observed at any time of observation. Sensitisation was not evident during the observation period. All animals survived throughout the test period. No signs of toxicity were recorded.

Appropriate positive and negative control groups were in place, with expected reactions.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data from the key sensitisation study for 1,3,5-tris[3-(trimethoxysilyl)propyl]-1,3,5-triazinane-2,4,6-trione, no classification for skin sensitisation is required according to Regulation (EC) No 1272/2008.