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EC number: 440-560-7 | CAS number: 346709-25-9
Toxicological information
Skin sensitisation
Currently viewing:
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 guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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
- Justification for non-LLNA method:
- When this study was performed, the OECD guideline for the LLNA did not yet exist.
Test material
- Reference substance name:
- -
- EC Number:
- 440-560-7
- EC Name:
- -
- Cas Number:
- 346709-25-9
- Molecular formula:
- Unspecified
- IUPAC Name:
- 2,6,8-triamino-4H,10H-pyrimido[5,4-g]pteridin-4-one; pyrimido[5,4-g]pteridine-2,4,6,8-tetramine
- Details on test material:
- - Description: Yellow powder
- Batch: TKP 50052
- Purity: 94.8 %
- Test substance storage: At room temperature in the dark
- Stability under storage conditions: Stable
- Expiry date: 06 November 2005
- Stability in vehicle - Water: At least 4 h
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: approx. 7 weeks old
- Weight at study initiation: 424 - 494 g
- Housing: Group housing of 5 animals
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid (1000 mg/kg) (Charles River Breeding and Maintenance Diet for Guinea Pigs, Altromin, Lage, Germany)
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 2, 5, 10 and 20 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 2, 5, 10 and 20 %
- No. of animals per dose:
- Experimental group: 10
Control group: 5 - Details on study design:
- RANGE FINDING TESTS: A preliminary irritation study was conducted in order to select test substance concentrations to be used in the main study. For the induction exposures the highest possible concentration that produced mild to moderate irritation (grades 2 - 3) was used. For challenge exposure the maximum non-irritant concentration was used. Practical feasibility of administration determined the highest starting-concentration for each route. The starting- and subsequent concentrations were taken from the series: 100% (undiluted), 50%, 20%, 10%, 5%, 2%, 1% and if needed, further lower concentrations using the same steps. For intradermal induction the highest concentration was the maximum concentration that could technically be injected.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 24 and 48 hours
- Site: scapular region
- Frequency of applications: each induction once
- Duration: 2 weeks
- Concentrations: intradermally injected with a 2 % concentration and epidermally exposed to a 50 % concentration.
- Volume: Intradermal injections = 0.1 ml/site; Epidermal application = 0.5 ml
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Second challenge one week after first challenge
- Exposure period: 24 hours
- Site: contralateral flank
- Concentrations: 50 % test substance concentration
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressing - Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamicaledhyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: first challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: first challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: first challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: first challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- grade 1 reaction (slight)
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: grade 1 reaction (slight).
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: first challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- grade 1 reaction (slight)
- Remarks on result:
- other: Reading: other: first challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: grade 1 reaction (slight).
- Reading:
- other: first challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: first challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- grade 1 reaction (slight)
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: grade 1 reaction (slight).
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- grade 1 reaction (slight)
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: grade 1 reaction (slight).
Any other information on results incl. tables
Since comparable skin reactions were observed in one control animal and based on the inconsistency in results, it was considered that all reactions observed were signs of non-specific irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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