Registration Dossier
Registration Dossier
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EC number: 604-075-6 | CAS number: 138401-24-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 May 1996 to 18 July 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study. GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Freund's complete adjuvant test
Test material
- Reference substance name:
- 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-ene-3-yl)methyl)(1,1'-biphenyl)-2-carbonitrile
- EC Number:
- 604-075-6
- Cas Number:
- 138401-24-8
- Molecular formula:
- C25H27N3O
- IUPAC Name:
- 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-ene-3-yl)methyl)(1,1'-biphenyl)-2-carbonitrile
- Reference substance name:
- Spiromethyl-biphenyl-nitrile
- IUPAC Name:
- Spiromethyl-biphenyl-nitrile
- Details on test material:
- - Name of test material (as cited in study report): SR 47563
- Lot/batch No.: 6R00003
- Physical state: light yellow and fine powder
- Analytical purity: considered 100%
- Expiration date of the lot/batch: not supplied
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Age at study initiation: about 6weeks old
- Weight at study initiation: 250-550g
- Housing: building G4
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days between animal arrival and start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 3°C
- Humidity (%): >=45% R.H.
- Air changes (per hr): >= 22 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial)/12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.1 ml intradermal injections of selected concentrations (100 g/Kg ethanol + adjuvant)
0.5ml topical application of the test material in a 71% paste in absolute ethanol (induction and challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.1 ml intradermal injections of selected concentrations (100 g/Kg ethanol + adjuvant)
0.5ml topical application of the test material in a 71% paste in absolute ethanol (induction and challenge)
- No. of animals per dose:
- 10 males, 10 females for treatment groups; 5 males, 5 females for controls. (main test)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 ml (710 g/Kg ethanol)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml (710 g/Kg ethanol). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml (710 g/Kg ethanol)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml (710 g/Kg ethanol). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
No mortality was observed during the test.
Body weight changes in the treated animals were not influenced by treatment when compared to controls.
Signs of irritation were noted during induction after application of sodium lauryl sulfate in both groups.
After challenge, the macroscopic examinations did not reveal any lesion of delayed hypersensitivity in the 20 treated animals. No cutaneous abnormality was noted in the 10 guinea-pigs examined in the control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions employed, the test article did not provoke any reaction of cutaneous sensitization in the animals examined.
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