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Toxicological information

Skin sensitisation

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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:
1990
Bibliographic source:
Contact Dermatitis 1990: 22: 37—41

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

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 group
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.