Registration Dossier
Registration Dossier
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EC number: 275-863-1 | CAS number: 71701-14-9
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:
- other: Guideline study, GLP
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-)
- EC Number:
- 275-863-1
- EC Name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-)
- Cas Number:
- 71701-14-9
- Molecular formula:
- C34H28Cl2CoN10O8S2.Na
- IUPAC Name:
- Cobaltate(1-), bis[3-[2-[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-(oxo-kO)-1H-pyrazol-4-yl]diazenyl-kN1]-4-(hydroxy-kO)-N-methylbenzenesulfonamidato(2-)]-, sodium (1:1)
- Details on test material:
- Purity: 94.79 % (w/w), by Elemental Analysis
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; B.V. Postbus 6174; NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: no data
- Housing: Single caging.
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30 - 86
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 /12
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 6.25, 12.5, and 25 % (w/v) in methyl ethyl ketone
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- positive SI =8,44 at 25 %
positive SI =3,12 at 10 %
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see below
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see below
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was found to be not a skin sensitiser under the described conditions.
- Executive summary:
In order to study a possible contact allergenic potential of the test item, three groups each of four female mice were treated daily with the test item at concentrations of 6.25, 12.5, and 25 % (w/v) in methyl ethyl ketone by topical application to the dorsum of each ear lobe (left and right) for three consecutive days.
A control group of four mice was treated with the vehicle (methyl ethyl ketone) only.
Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight.
The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.
All treated animals survived the scheduled study period.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 1.1, 0.9, and 1.2 were determined with the test item at concentrations of 6.25, 12.5, and 25 % (w/v) in methyl ethyl ketone. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
CONCLUSION
The test item was found to be not a skin sensitiser under the described conditions.
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