Registration Dossier
Registration Dossier
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EC number: 603-373-3 | CAS number: 129909-90-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Sept 1994 to 28 Oct 1994
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- (1984)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Version / remarks:
- (1989)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200 (Guidance on toxicology study data for application of agriculture chemical registration) (1985)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide
- EC Number:
- 603-373-3
- Cas Number:
- 129909-90-6
- Molecular formula:
- C10H19N5O2
- IUPAC Name:
- 4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide
- Reference substance name:
- Technical Grade MKH 3586
- IUPAC Name:
- Technical Grade MKH 3586
- Details on test material:
- - Name of test material (as cited in study report): Technical Grade MKH 3586
- Physical state: Beige powder
- Analytical purity: 98.2%
- Purity test date: 17 Jun 1994
- Lot/batch No.: 17004/93
- Expiration date of the lot/batch: 6 months from date of purity testing
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Neat (test material not diluted)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Neat (test material not diluted)
- No. of animals per dose:
- Induction and challenge: 10 animals/sex
Challenge: 5 animals/sex
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Induction and challenge
- Dose level:
- Neat test material
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Induction and challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Induction and challenge
- Dose level:
- Neat test material
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Induction and challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- other: Induction and challenge
- Dose level:
- Neat test material
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: other: Induction and challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge
- Dose level:
- Neat test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge
- Dose level:
- Neat test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- other: challenge
- Dose level:
- Neat test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: other: challenge. Dose level: Neat test material. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Any other information on results incl. tables
OBSERVATIONS:
Clinical / skin:
No clinical signs of toxicity or other lesions were observed. At each of the 24, 48 and 72 hour scorings for the three induction exposures no erythema was observed in any test animal. Following the challenge dose, both the test and non-induced animals were judged to be free of erythema at 24, 48 and 72 hours post exposure. Subsequently, both male and female test animals had an incidence index of 0.0 and a severity index of 0.0 following the challenge dose.
Bodyweight:
No test material related effects observed.
Mortality:
All animals survived to the end of the experimental phase.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this Buehler topical-closed patch study MKH 3586 did not have any potential to cause dermal sensitisation in guinea pigs.
- Executive summary:
In a Buehler topical closed-patch study MKH 3586 was assessed for its potential to induce skin sensitisation. The test and non-induced control groups consisted of 10 animals/sex and 5 animals/sex, respectively, with the test material administered undiluted as a solid (0.4g) moistened with deionised water just prior to application. Animals in the test group received 3 topical applications for induction on days 0, 7 and 14 followed by a 14-day rest period, followed by topical challenge on day 28. Animals in the non-induced control group received only the challenge application on day 28.
There was no test material related effect on body weight. No other toxic lesions or effects were observed.
No erythema was evident in either sex following any of the 3 induction exposures. No erythema was observed at the dose site of any of the test or non-induced control animals after the challenge dose. Therefore, the test animals had an incidence index of 0.0 and a severity index of 0.0 following the challenge dose.
Based on the results of this Buehler topical-closed patch study MKH 3586 did not have any potential to cause dermal sensitisation in guinea pigs.
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