Registration Dossier
Registration Dossier
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EC number: 226-106-9 | CAS number: 5280-78-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- EC Number:
- 226-106-9
- EC Name:
- N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Cas Number:
- 5280-78-4
- Molecular formula:
- C40H23Cl5N6O4
- IUPAC Name:
- N,N'-(2-chloro-1,4-phenylene)bis{4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthamide}
- Test material form:
- solid
- Details on test material:
- - Substance type: red solid
- Physical state: solid
- Analytical purity: 99.6%
- Purity test date: 1.12.2006
- Expiration date of the lot/batch: March 10, 1990
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
Constituent 1
- Specific details on test material used for the study:
- - Substance type: red solid
- Physical state: solid
- Analytical purity: 99.6%
- Purity test date: 1.12.2006
- Expiration date of the lot/batch: March 10, 1990
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 2.5, 5, and 10%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
a pretest was performed in two mice on three consecutive days.
- Compound solubility: The data showed that the highest test item concentration, which could be technically used was a 10% solution. Higher concentrations could not be achieved with other vehicles (e.g. acetone:olive oil, methyl ethyl ketone, propylene glycol, DMSO, or ethanol:water).
- Irritation: Irritation of the ear skin could not be observed, due to the colour of the test item.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: 3fold increase of S.I.
TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by topical (epidermal) application to the dorsal
surface of each ear lobe (left and right) with different test item concentrations of 2.5, 5, and 10% (w/v) in dimethylformamide. The application volume, 25 µl, was spread over the entire dorsal surface ( 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- EC3 = 6.7%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 1.53, 1.43, and 2.37
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Control: 5703 2.5%: 8735 5%: 8128 10%: 13466
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. Due to the colour of the test item iritation of the ear skin could bot be observed at the mid and high dose.
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, 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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