Registration Dossier
Registration Dossier
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EC number: 428-410-9 | CAS number: 67014-36-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-04-28 - 1998-05-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 428-410-9
- EC Name:
- -
- Cas Number:
- 67014-36-2
- Molecular formula:
- C8 H9 N3 O
- IUPAC Name:
- 5-amino-6-methyl-2,3-dihydro-1H-1,3-benzodiazol-2-one
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: Source : Charles River, Germany
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: < 500 g
- Housing: Group-housing of 5 animals
- Diet: standard guinea pig diet, ad libitum (LC 23-B, pellet diameter 4mm)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: 3 different injections
A) 1:1 w/w mixture of Freunds' Complete Adjuvant (Difco, Detroit, USA) with water for injection (Fresenius AG, Bad Homburg, Germany
B) The test substance at a 2% concentration
C) 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant (4 animals) or separate injections of solutions A) and B) (0.05 ml each) given very close together (remaining animals)
Challenge: 50 % w/w in vehicle
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: 3 different injections
A) 1:1 w/w mixture of Freunds' Complete Adjuvant (Difco, Detroit, USA) with water for injection (Fresenius AG, Bad Homburg, Germany
B) The test substance at a 2% concentration
C) 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant (4 animals) or separate injections of solutions A) and B) (0.05 ml each) given very close together (remaining animals)
Challenge: 50 % w/w in vehicle
- No. of animals per dose:
- 4 animals for irritation study
10 animals for induction and challenge study
5 animals for the control group - Details on study design:
- RANGE FINDING TESTS:
Prior to the start of the Main study, the intradermal and epidermal irritancy of the test substance was investigated to select test substance concentrations suitable for the induction and challenge phase of the Main Study. The test system, procedures and techniques were identical to those used during the main study, unless otherwise specified. The animals were selected from stock and were between 5 and 9 weeks old, and as a consequence the body weights could exceed 500 grams. Body weights were determined prior to treatment. A series of four test substance concentrations was used for Induction; the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1 mL/site) in the clipped scapular region.
A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 mL each) per animal to the clipped flank, using Metalline patches (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape' and subsequently Coban elastic bandage. The animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of residual test substance.
The injection sites and treated skin areas were assessed for irritation 24 and 48 hours after treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 injections
- Exposure period: 48 hours
- Test groups: 10 female animals
- Control group: 5 female animals
- Site: scapular region
- Duration: 21 days
- Concentrations:
A) 1:1 w/w mixture of Freunds' Complete Adjuvant (Difco, Detroit, USA) with water for injection (Fresenius AG, Bad Homburg, Germany
B) The test substance at a 2% concentration
C) 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant (4 animals) or separate injections of solutions A) and B) (0.05 ml each) given very close together (remaining animals)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 day
- Exposure period: 24 hours
- Test groups: 10 female animals
- Control group: 5 female animals
- Site: scapular region
- Concentrations: 50% in vehicle
- Evaluation (hr after challenge): 24 and 48 hours after removal of dressing - Challenge controls:
- The control groups were challenged in the way as the test animals.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Preliminary Study
The necrosis seen at intradermal injection of the lower concentrations (2% and 1%) was considered to be caused mainly by the propylene glycol rather than the test substance. This is confirmed by the consistent diameter of the necrotic area seen in the control animals after the intradermal injection with propylene glycol only in the main study. Based on these results, the test substance concentrations selected for the Main Study were a 2% concentration for the intradermal induction and a 50% concentration for the epidermal induction exposure. No signs of irritation were observed to the highest test substance concentration tested in the preliminary irritation study. Therefore, the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction. A 50% test substance concentration was selected for the challenge phase.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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