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EC number: 619-590-1 | CAS number: 135302-13-5
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:
- other: GLP study according EU/OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3-methoxy-4-methyl-4,5-dihydro-1H-1,2,4-triazol-5-one
- EC Number:
- 619-590-1
- Cas Number:
- 135302-13-5
- Molecular formula:
- C4H7N3O2
- IUPAC Name:
- 3-methoxy-4-methyl-4,5-dihydro-1H-1,2,4-triazol-5-one
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Concentration / amount:
- Intradermal induction: 5% (= 20 mg test item/animal)
Topical induction: 25% (= 125 mg test item/animal)
Challenge: 25% (= 125 mg test item/animal)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Concentration / amount:
- Intradermal induction: 5% (= 20 mg test item/animal)
Topical induction: 25% (= 125 mg test item/animal)
Challenge: 25% (= 125 mg test item/animal)
- No. of animals per dose:
- test group: 10 animals
control group: 5 animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Slight localized redness
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: Slight localized redness.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Slight localized redness
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Slight localized redness.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No reaction.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No reaction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No reaction.
Any other information on results incl. tables
After the intradermal induction the animals in the control group and in the test item group showed strong effects up to encrustation at the injection sites of the first induction.
After the intradermal induction (first induction) the animals in the control group
showed after 48 hours:
• red wheal with red surrounding
• white wheal with red surrounding
• white wheal with encrustation
The animals in the test item group showed after 48 hours:
• red wheal with red surrounding
• white wheal with red surrounding
• encrustation
After 7 days the following effects were recorded at the injection sites in the control
group and in the test item group: red wheal with red surrounding and encrustations.
At day 9, directly after removal of the patch of the second induction, the treatment
area of the second induction showed no skin effects in the animals of the test item
group and the control group.
The challenge with the 25% test item formulation led to skin effects (grade 1) in 7 of 10 animals (70%) in the test item group and no skin effects were seen in the control group animals. In summary, by comparing the results in the treatment group and in the control group under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits a skin-sensitization potential.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In summary, under the conditions of the maximization test and with respect to the
evaluation criteria the test item therefore exhibits a skin-sensitization potential.
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