Registration Dossier
Registration Dossier
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EC number: 257-776-0 | CAS number: 52238-92-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]
- EC Number:
- 257-776-0
- EC Name:
- N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]
- Cas Number:
- 52238-92-3
- Molecular formula:
- C42H22Cl4F6N6O4
- IUPAC Name:
- N,N'-(2,5-dichloro-1,4-phenylene)bis(4-{[2-chloro-5-(trifluoromethyl)phenyl]diazenyl}-3-hydroxy-2-naphthamide)
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- Aggregate state at room temperature: solid
Colour: Yellowish-Red
Stability in solvent: > 24 hrs in OMSO at room temperature
Storage: At room temperature
Expiry date: August 17,2009
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, NL - 5960 AD Horst
- Age at study initiation: 8 - 12 weeks (beginning of acclimatization)
- Weight at study initiation: mean 18.5g
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2004-11-03 To: 2004-11-09
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 7.5, 15 and 30%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The data showed that the highest test item concentration, which can be used was a 30 % suspension in acetone:olive oil, 4:1 (viv). In DMF or DMSO only up to 20 % could be suspended
- Irritation: In a non-GLP conform pre-test in !wo mice, test item concentrations of 5, 10, 20, and 30 % (w/v) were tested on one ear each. No irritation effects were observed at these concentrations after a single application. (Due to the intense red colour of the test item local irritation reactions such as ear redness could not be detected" No swelling of the ears was observed.)
- Lymph node proliferation response: not measured in the range-finder
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation
- Criteria used to consider a positive response: 3fold increase in Stimulation index compared to vehicle control
TREATMENT PREPARATION AND ADMINISTRATION: Substance was suspended in vehicle on the day of treatment. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Included for body weight and SI
Results and discussion
- Positive control results:
- performed in April 2004, a-Hexylcinnamaldehyde in Acetone/olive oil. EC3 = 6.3%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- ca. 0.5
- Test group / Remarks:
- Concentration 30%
- Parameter:
- SI
- Value:
- ca. 0.7
- Test group / Remarks:
- Concentration 15%
- Parameter:
- SI
- Value:
- ca. 0.8
- Test group / Remarks:
- Concentration 7.5%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM per lymph node: Control: 521 7.5% = 424 15% = 348 30% = 259
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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