Registration Dossier
Registration Dossier
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EC number: 212-728-8 | CAS number: 860-22-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Occupational dermatitis in animal feed mill workers
- Author:
- G. MANCUSO, M. STAFFA, A. ERRANI, R. M. BERDONDINI AND P. FABBRI
- Year:
- 1 990
- Bibliographic source:
- Contact Dermatitis 1990: 22: 37—41
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Evaluate allergic contact dermatitis of Indigo carmine in 15 different northern Italian animal feed mills worker by Patch test.
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- not known
Test material
- Reference substance name:
- Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
- EC Number:
- 212-728-8
- EC Name:
- Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
- Cas Number:
- 860-22-0
- Molecular formula:
- C16H10N2O8S2.2Na
- IUPAC Name:
- disodium 3,3'-dioxo-1,1',3,3'-tetrahydro-2,2'-biindole-5,5'-disulfonate
- Reference substance name:
- Indigo carmine
- IUPAC Name:
- Indigo carmine
- Details on test material:
- - Name of test material (as cited in study report): Indigo carmine- Molecular formula (if other than submission substance): C16H8N2Na2O8S2- Molecular weight (if other than submission substance): 466.35 g/mol- Substance type: Organic- Physical state: Solid- Purity: No data available- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- Details on test animalTEST ANIMALS- Source: 15 different northern Italian animal feed mills- Age at study initiation: mean age 41 years, range 19-60 years- Weight at study initiation: No data available - Housing: No data available- Diet (e.g. ad libitum): No data available- Water (e.g. ad libitum): No data available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
Challenge
- Concentration / amount:
- 1%
- No. of animals per dose:
- 204 worker (191 male and 13 female)
- Details on study design:
- Details on study designRANGE FINDING TESTS: No data MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 1- Exposure period: 48 hr- Test groups: - Control group: No data- Site: Back side- Frequency of applications: 1- Duration: 48 hr and 96 hr- Concentrations: 1%B. CHALLENGE EXPOSURE- No. of exposures: No data- Day(s) of challenge: No data- Exposure period: No data- Test groups: No data- Control group: No data- Site: No data- Concentrations: No data- Evaluation (hr after challenge): No data
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 204
- Clinical observations:
- Contact dermatitis
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 204.0. Clinical observations: Contact dermatitis.
Any other information on results incl. tables
other details not known
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance indigo carmine is reported to be skin sensitizing to human.
- Executive summary:
The indigo carmine compound was patch tested for the allergy in the 204 (191 male and 13 female) worker from 15 Italian feed mills. 1% test substance in petrolatum was applied on back of workers using Scanpor tape (Norgesplaster,
Norway) for 48 hr. Reactions were read at 48 and 96 h according to the ICDRG scale. Indigo carmine shows positive reaction in two cases. 3 workers (workers with cutaneous complaints (contact dermatitis or pruritus sine materia)) shows positive reaction and 2 workers (workers without cutaneous complaints) shows positive reaction. Hence, the substance indigo carmine is reported to be skin sensitizing to human.
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