Registration Dossier
Registration Dossier
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EC number: 255-005-2 | CAS number: 40618-31-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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 (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- EC Number:
- 255-005-2
- EC Name:
- N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Cas Number:
- 40618-31-3
- Molecular formula:
- C40H22Cl6N6O4
- IUPAC Name:
- N,N'-(2,5-dichloro-1,4-phenylene)bis{4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthamide}
- Test material form:
- solid
- Details on test material:
- Description: Red solid
Batch number: W02002
Purity / Formulation: >99.91%
Stability of test item: Stable under storage conditions.
Expiry date: 20-AUG-2009
Stability of test item dilution: Unknown in PEG 300; excluded from the statement of compliance.
Storage conditions: At room temperature (range of 20 ± 5 °C, provided by RCC), light protected.
Constituent 1
- Specific details on test material used for the study:
- - Substance type: red solid
- Physical state: solid
- Analytical purity: 99.91%
- Purity test date: 20 August 2004
- Lot/batch No.: W02002
- Expiration date of the lot/batch: August 20, 2009
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Stability in solvent: > 24 hrs in DMSO at room temperature
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands
- Age at study initiation: 8 - 12 weeks (beginning of acclimatization)
- Weight at study initiation: mean 18.3 g
- Housing: single caging
- 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: 2004-08-27 To: 2004-11-16
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, and 15 % (w/v).
- No. of animals per dose:
- 4
- Details on study design:
- To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in two mice with concentrations of 2.5, 5, 10, and 15 % (w/v) (pretest excluded from Statement of Compliance). The data showed that the highest test item concentration, which could be technically used, was a 15 % suspension in acetone:olive oil, 4:1 (w/v). Also in other vehicles tested (DMSO, DMF), a higher concentration could not be suspended.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- not needed.
Results and discussion
- Positive control results:
- performed in October 2004 (RCC-CCR Study No. 860600) EC3 = 9.9%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 0.9, 0.9, and 1.3
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 3855.2 (control) 3352.4 (5%) 3507.5 (10%) 4999.2 (15%)
Any other information on results incl. tables
No deaths occurred during the study period.
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Reddening of the ears could not be determined since the ears were dyed red by the test item. However, no other signs of local irritation such as swelling of the ears could be observed.
The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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