Registration Dossier
Registration Dossier
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EC number: 947-290-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Magnusson Kligman Guinea Pig Maximisation Test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1993
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, not according to an OECD test guideline, available as unpublished report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Guinea Pig Maximisation Test (GPMT) of Magnusson and Kligman
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 8-azaspiro[4,5]decane-8-{4-[4''-(2'''-pyrimidinyl)-1''-piperazinyl]-butyne/2/-yl}-7,9-dione /E/-2-butenedionate
- EC Number:
- 947-290-3
- Cas Number:
- 118286-97-8
- Molecular formula:
- C21H27N5O2 × C4H4O4
- IUPAC Name:
- 8-azaspiro[4,5]decane-8-{4-[4''-(2'''-pyrimidinyl)-1''-piperazinyl]-butyne/2/-yl}-7,9-dione /E/-2-butenedionate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Buspiron XI. fázistermék
- Physical state: white odourless powder
- Lot/batch No.: 1/1992
- Storage condition of test material: room temperature, protected from light
Constituent 1
- Specific details on test material used for the study:
- The following solutions were used for the treatment
- 0,1 mL Freunds Complete Adjuvant (FCA)
- 1% solution of the test material (CAS 118286-97-8) - vehicle: paraffin oil (paraffinum liquidum)
- 1% solution of the test material (CAS 118286-97-8) - homogenised in Freunds Complete Adjuvant
- negative control: paraffin oil (vehicle)
- positive control: 0,1% potassium dichromate solution - homogenised in physiological saline
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Remarks:
- Albino guinea pigs were used for the study.
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species: Guinea pig (albino)
- Sex of animals: male
- Number of animals: 3
- Source of animals: Charles River Company
- Weight of study animals determined at the beginning of the study: 277-381 g
ENVIRONMENTAL CONDITIONS
- Housing conditions: Animals were kept in cages - 5 animals / cage
- Size of cages: 20 x 46 x 42 cm
- Temperature in the experimental animal room: 22ºC +/- 3ºC
- Relative humidity: 50-70%
- Lighting: artificial - sequence: 12 hours light, 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1% solution of the test material
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, open
- Vehicle:
- petrolatum
- Remarks:
- white petrolatum
- Concentration / amount:
- 1% solution of the test material
- Day(s)/duration:
- duration time of exposure: 48 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- petrolatum
- Remarks:
- white petrolatum
- Concentration / amount:
- 1% solution of the test material
- Day(s)/duration:
- duration time of exposure: 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- negative control: 10 animals (ID of test animals: 1-10)
positive control : 10 animals (ID of test animals: 11-20)
treatment: 10 animals (ID of test animals: 61-70) - Details on study design:
- Animals were treated intradermally.
7 days after the intradermal treatment, animals were treated (epicutaneous exposure) for 48 hours.
14 days after the epicutaneous treatment, animals were treated (challege: epicutaneous exposre) for 24 hours. - Challenge controls:
- Negative control: petrolatum.
Positive control: Potassium dichromate (0,1% solution; dissolved in a 0,9% physiological saline solution) - Positive control substance(s):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% solution of the test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% solution of the test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Reaction of animals to challenge exposure
| Skin reaction to challenge exposure | ||||
| Group | ID of test animal | 24 hours after treatment | 48 hours after treatment | 72 hours after treatment |
| negative control (vehicle: petrolatum) | 1 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | |
| 4 | 0 | 0 | 0 | |
| 5 | 0 | 0 | 0 | |
| 6 | 0 | 0 | 0 | |
| 7 | 0 | 0 | 0 | |
| 8 | 0 | 0 | 0 | |
| 9 | 0 | 0 | 0 | |
| 10 | 0 | 0 | 0 | |
| positive control (potassium dichromate solution) | 11 | + | + | + |
| 12 | + | + | + | |
| 13 | + | + | + | |
| 14 | + | + | + | |
| 15 | + | + | + | |
| 16 | + | + | + | |
| 17 | + | + | + | |
| 18 | + | + | + | |
| 19 | + | + | + | |
| 20 | + | + | + | |
| treatment (test material; vehicle: petrolatum) | 61 | 0 | 0 | 0 |
| 62 | 0 | 0 | 0 | |
| 63 | 0 | 0 | 0 | |
| 64 | 0 | 0 | 0 | |
| 65 | 0 | 0 | 0 | |
| 66 | 0 | 0 | 0 | |
| 67 | 0 | 0 | 0 | |
| 68 | 0 | 0 | 0 | |
| 69 | 0 | 0 | 0 | |
| 70 | 0 | 0 | 0 | |
0: no skin reaction observed
+: skin sensitisation observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not cause skin sensitization in the tested concentration.
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