Registration Dossier
Registration Dossier
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EC number: 485-140-4 | CAS number: 515815-48-2
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:
- 21-02-2006 until 17-03-2006.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with several internationally established guidelines (OECD, EEC, EPA guidelines, see below).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 485-140-4
- EC Name:
- -
- Cas Number:
- 515815-48-2
- Molecular formula:
- C33 H30 N4 O2 x HCl
- IUPAC Name:
- 4’-(2-Propyl-4-methyl-6-(1-methylbenzimidazolyl-2-yl)-benzimidazol-1-ylmethyl)biphenyl-2-carbonsäure Hydrochlorid
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): BIBR 227 CL
- Physical state: solid
- Analytical purity: 99.8%
- Impurities (identity and concentrations): not stated
- Composition of test material, percentage of components: not stated
- Purity test date: 17 October 2005
- Lot/batch No.: 9
- Expiration date of the lot/batch: April 2006
- Stability under test conditions: yes
- Storage condition of test material: at room temperature, dark and dry.
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: LAB-ALL, Bt. Budapest, 1174 Hunyadi
- Weight at study initiation: 331-350g
- Housing: al animals were housed in Macrolon cages, size III, with 2-3 animals per cage.
- Diet (e.g. ad libitum): PURISTAR standard diet for rabbit ad libitum
- Water (e.g. ad libitum): tap water ad libitum, with 50 mg/100 mL ascorbic acid.
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70% (relative humidity)
- Air changes (per hr): 8-12 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light daily from 6 am - 6pm (artificial light).
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: methyl cellulose (1%)
- Concentration / amount:
- Induction exposure (intradermal): 0.01%
Induction exposure (epicutaneous): 50%
Challenge (epicutaneous): 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: methyl cellulose (1%)
- Concentration / amount:
- Induction exposure (intradermal): 0.01%
Induction exposure (epicutaneous): 50%
Challenge (epicutaneous): 10%
- No. of animals per dose:
- 10 test animals, 5 control animals per test.
- Details on study design:
- RANGE FINDING TESTS: a preliminary dose-finding study was performed.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 for intradermal test, 1 for epicutaneous test.
- Exposure period: 24h (intradermal), 48h (epicutaneous)
- Test groups: 1 group, 10 animals per group
- Control group: 1 group, 5 animals per group
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: day 22 after first induction test
- Exposure period: 24 hours
- Test groups: 1 group, 10 animals per group
- Control group: 1 group, 5 animals per group
- Evaluation (hr after challenge): 24 and 48 hrs after exposure. - Challenge controls:
- Challenge controls were treated with the text substance at c=10%.
- Positive control substance(s):
- yes
- Remarks:
- seperate reliability studies are carried out twice a year, but not at this testing stage. Results are available.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- challenge concentration: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: challenge concentration: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- challenge concentration: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: challenge concentration: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- challenge concentration: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: challenge concentration: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- challenge concentration: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: challenge concentration: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Any other information on results incl. tables
The evaluation was made according to the scoring system by Draize (1959).
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Challenge with the test item BIBR 277 CL caused no positive response in test animals previously sensitised. At the same time, none of the control animals showed sings of skin sensitisation. The net response value was thus 0%, as no indications for adverse skin reactions were noted.
The test item was classified as a non-senisitiser, based on this guinea pig test and according to current EU-regulations.
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