Registration Dossier
Registration Dossier
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EC number: 918-045-8 | CAS number: -
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-8-20 to 1997-9-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The albino guinea-pig was chosen as the test species as it had been shown to be a suitable model for skin sensitisation studies and is the animal recommended in the test guideline. In addition, study completed prior to LLNA being adopted as an acceptable method.
Test material
- Reference substance name:
- 5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1H,4H,7H-pyrazolo[4,3-d]pyrimidin-7-one
- EC Number:
- 918-045-8
- Cas Number:
- 139755-83-2
- Molecular formula:
- C22H30N6O4S
- IUPAC Name:
- 5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1H,4H,7H-pyrazolo[4,3-d]pyrimidin-7-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 92480/J/17/1
- Expiration date of the lot/batch: Not supplied
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid: Diluted with Alembicol D depending on test
FORM AS APPLIED IN THE TEST (if different from that of starting material)
1% w/v in Alembicol D for the Induction intradermal injection
50% w/v in Alembicol D for the induction topical application
50% and 25% w/v in Alemvicol D for the topical challenge
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: 4-7 weeks
- Weight at study initiation: 300-381 g
- Housing: Groups of five in suspended metal cages with wire mesh floor. The control animals was seperate from the test animals. Hay was given weekly.
- Diet (e.g. ad libitum): Vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SOC) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-28.5
- Humidity (%): 39-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 1% w/v
- Day(s)/duration:
- 3
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- other: 50:50 mixture of Freund's complete adjuvant and Alembicol D.
- Concentration / amount:
- 1% w/v
- Day(s)/duration:
- 3
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- other: 50:50 mixture of Freund's complete adjuvant and Alembicol D
- Remarks:
- Alembicol D is a coconut derivative
- Concentration / amount:
- 0% w/v
- Day(s)/duration:
- 3
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 50% w/v
- Day(s)/duration:
- 2
- Adequacy of induction:
- other: Highest technically applicable concentration and skin pre-treated with 10% SDS
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 50% w/v
- Day(s)/duration:
- 1
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 25% w/v
- Day(s)/duration:
- 1
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 15
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 exposure each with a different vehicle and/or concentration in a different location
- Exposure period: Not defined
- Test groups: Test animals 4000-4009
- Control group: Control animals 3995-3999
- Site: Anterior, Anterior and Posterior Repective to numbering below
- Frequency of applications: Once
- Concentrations:
Control animals:
(1) 0.1 ml of Freunds complete adjuvant 50 : 50 with water for irrigation (Wail,
(2) 0,1 ml of Alembicol D.
(3) 0.1 mi of Freunds complete adjuvant 50 : 50 with Alembicol D.
Test animals:
(1) 0.1 ml of Freund's complete adjuvant 50 : 50 with water för irrigation (Ph.Eur.),
(2) 0.1 mi of 11K-92,480% I % wtv in Alembiool D.
(3) 0.1 ml of UK-92,480 1% 1,viv in a 50 : 50 mixture of Alembicol D and Freund's complete adjuvant.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks
- Exposure period: 24 hours
- Test groups: Animals 4000-4009
- Control group: Animals 3995-3999
- Concentrations: 50% w/v in Alembicol D and 25% w/v in Alembicol D
- Site: Anterior and Posterior respectively
- Evaluation (hr after challenge): 24/48/72 - Challenge controls:
- Comparison to positive controls that used known irritants
- Positive control substance(s):
- yes
- Remarks:
- HCA & MBT
Results and discussion
- Positive control results:
- The postiive control showed the same results as the test animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% w/v in Alembicol D,
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd Reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% w/v in Alembicol D
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema was observed in test animals following topical application
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd Reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd Reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd Reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This test substance does not meet the criteria for this substance to be listed as a skin sensitizer per GHS criteria.
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