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EC number: 202-936-7 | CAS number: 101-37-1
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vivo test for skin sensitisation according to OECD Guidance 406 (guinea pig maximisation test) is already available. Thus, the informtion requirement is fulfilled, and for animal welfare reasons, another in vivo test is not conducted.
Test material
- Reference substance name:
- 2,4,6-triallyloxy-1,3,5-triazine
- EC Number:
- 202-936-7
- EC Name:
- 2,4,6-triallyloxy-1,3,5-triazine
- Cas Number:
- 101-37-1
- Molecular formula:
- C12H15N3O3
- IUPAC Name:
- tris(prop-2-en-1-yloxy)-1,3,5-triazine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White (Bor: DAPW)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann /Borchen
- Age at study initiation: 9 weeks
- Weight at study initiation: males: 410-473 g; females 375-421 g
- Housing: individually, Macrolon cages Type III
- Diet (e.g. ad libitum): ssniff (G) ad libitum
- Water (e.g. ad libitum): tap water ad libitum (twice weekly + vitamin C)
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS: according to guideline
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 1st application: Induction with 0.1 mL of a 3 % (w/w) solution in peanut oil
- Adequacy of induction:
- other: maximum non-irritating concentration
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 2nd application: Induction with 0.7 mL undiluted test substance (30-35°C)
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 3rd application: Challenge with 0.2 mL undiluted test substance (30-35°C)
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- control group: 10 animals
treatment group: 10 animals - Details on study design:
- RANGE FINDING TESTS: In preliminary tests, the maximum non-irritating concentration for the intradermal or the slight to moderate irritating concentration for the epidermal application during the induction phase as well as a non-irritating concentration for the epidermal application during the challenge phase were determined
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: day 1 intradermal and day 8 epicutaneous for 48 h
- Test groups: 1 with 10 animals
- Control group: 1 with 10 animals
- Site: intradermal - scapular region three pairs of intradermal injections in two parallel lines; epicutaneous - same region was covered with a patch
- Frequency of applications:
- Duration:
- Concentrations: treatment group: intradermal: pair one: FCA/ saline solution 1:1
pair two: test substance solution (3% (w/w) in peanut oil)
pair three: test substance solution / FCA 1:1
epicutaneous: undiluted (30-35°C)
control group: vehicle instead of tets substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups: occlusive patch with 0.2 mL undiluted test substance (30-35°C)
- Control group: identical to treatment group (right flank treated with vehicle alone in both groups)
- Site: right flank (vehicle), left flank (test substance)
- Concentrations: 0.2 mL undiluted test substance
- Evaluation (hr after challenge): 24 and 48 h after challenge - Positive control substance(s):
- yes
- Remarks:
- para-phenylenediamine
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 mL undiluted test substance (30-35°C)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 mL undiluted test substance (30-35°C)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.2 mL undiluted test substance (30-35°C)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.2 mL undiluted test substance (30-35°C)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- other: once per annum (latest examination: Sep./oct. 1989)
Any other information on results incl. tables
1 of 10 animals exhibited a slight erythema at the treated site 24 and 48 hours after removal of the patch. None of the animals of the control group showed changes at the exposed skin areas. Systemic toxic effects could not be detected. The general condition and body weight development of the test animals were not affected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no skin sensitising effects. The test item is classified as “non-sensitiser“ based on CLP Regulation (EC) No.1272/2008.
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