Registration Dossier
Registration Dossier
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EC number: 278-145-6 | CAS number: 75234-41-2
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: Standard 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:
- Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
- EC Number:
- 278-145-6
- EC Name:
- Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
- Cas Number:
- 75234-41-2
- Molecular formula:
- C40H26CrN8O14S2.3Na
- IUPAC Name:
- trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
- Test material form:
- other: solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Age at study initiation: ca 8 weeks
- Weight at study initiation: 19 - 24 g
- Housing: Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad ibitum
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25 C
- Humidity (%): 30 to 50 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0 - 10 - 25 - 50 %
- No. of animals per dose:
- 3
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION:
Animals were anesthetized by inhalation of isoflurane. The test material was applied to the back of the ears at a volume of 25µL per ear of the respective preparation. Administration was perform once a day for three consecutive days. The control animals were treated accordingly using the vehicle only.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: S.I. Control - 10 % 0,72 25 % 0,68 50 % 0,49
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM/group No. of nodes DPM/node Control 2317,05 10 225,86 10 % 1677,95 10 161,95 25 % 1583,91 10 152,55 50 % 1163,53 10 110,51
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item showed no indication of a skinn sensitizing potential in the local lymph node assay in mice.
- Executive summary:
After treatment of four groups of female CBA/J mice with the test item in acetone/olive oil (4/1) topically on the back of the ears on three consecutive days no proliferation of the draining lymph nodes was recorded as shown by a lack of increased incorporation of 3H-Thymidine in lymph node cells. The volume applied was 25 µL and the concentrations were 10 , 25, and 50 %. The stimulation index varied between 0,72 and 0,49.
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