Registration Dossier
Registration Dossier
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EC number: 213-834-7 | CAS number: 1025-15-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 May - 02 June 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 213-834-7
- EC Name:
- 1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 1025-15-6
- Molecular formula:
- C12H15N3O3
- IUPAC Name:
- tris(prop-2-en-1-yl)-1,3,5-triazinane-2,4,6-trione
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPOC:DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 400-470 g (males); 364-478 g (females)
- Housing: individually in Makrolon cages type IV
- Diet: ssniff® Ms-Z (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: time switched drinking water system (twice weekly ascorbic acid was added)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
according to guideline
IN-LIFE DATES: From: 04 May 1999 To: 02 June 1999
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: paraffin oil (control)
- Concentration / amount:
- Induction: 100%
Challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: paraffin oil (control)
- Concentration / amount:
- Induction: 100%
Challenge: 100%
- No. of animals per dose:
- Test substance group: 20 (10 males and 10 females)
Control group: 10 (5 males and 5 females) - Details on study design:
- RANGE FINDING TESTS: In a preliminary test no primary irritation of the test substance was observed.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.5 mL test substance
- Control group: 0.5 mL paraffin oil
- Site: left flank
- Frequency of applications: every 7 days
- Duration: days 1-15
- Concentration: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (only challenge, no rechallenge was conducted)
- Day(s) of challenge: 29
- Exposure period: 6 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: posterior right flank (test substance) and anterior right flank (vehicle)
- Concentration: 100%
- Evaluation: 24 h and 48 h after start of application - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole (last examination: Oct/Nov 1998)
Results and discussion
- Positive control results:
- The positive control substance mercaptobenzothiazole induced positive reactions in 4/10 animals (40%) at the substance treated site, thus meeting the reliability criteria for the Buehler test (≥15% positive response).
In vivo (non-LLNA)
Resultsopen allclose all
- 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:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- 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:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
In one female of the test substance group the left flank, which was treated with the vehicle paraffin oil, had a discrete or patchy erythema at only the 24 h observation time point. In the other animals the vehicle treated sites were without any findings.
No systemic toxic effects were observed. The general condition and body weight gain of the animals were not affected.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test item has no sensitising properties in the Buehler test on the skin of guinea pigs.
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