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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Reference:
Composition 0
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 information:
Composition 1
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
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
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
Positive control results:
No data available
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.

other details not known

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation:

 

Peer reviewed articles were viewed to determine the Skin sensitisation of the test compound C.I. Acid blue 74 (CAS no 860-22-0). The studies are summarized as below:

 

The indigo carmine compound (G. Mancuso et al 1990) 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.

 

From Patch testing to FD&C and D&C dyes 2003;Patch test of substanceFD&C Blue 2 was done with 21 patients. 2% of test substance in petrolatum was applied. No positive reaction was observed.

 

Skin sensetization effects were estimated from Danish (Q)SAR Database bythree different models i.e, Battery, Leadscope and SciQSAR used within Danish QSAR database for chemical Indigo carmine.Based on estimation skin sensetization effect were known when test chemicalIndigo carmine exposed toGuinea Pig and Human.

 

From review article (Richard J. Lewis, Sr., 2012)The indigo carmine compound was patch tested for the allergy in the 204 worker from 15 Italian feed mills. The prevalence of occupational contact dermatitis was 13.7%, 16.7% with contact dermatitis and 6.8% of asymptomatic subjects patch tested with indigo carmine. It shows that indigo carmine is skin sensitizing compound.

 

From review article (EFSA Journal., 2015) acute oral toxicity test was conducted on rat administered indigo carmine by oral route. LD50 value was found to be 2000 mg/kg. In acute oral toxicity test of chemical indigo carmine administered orally to rat.

 

 

Based on the key study used and its relative supporting data, the test material classify as Skin sensitisation.


Migrated from Short description of key information:
The indigo carmine compound (G. Mancuso et al 1990) 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.

Justification for selection of skin sensitisation endpoint:
Data is from peer reviw publication

Justification for classification or non-classification

Skin sensitisation:

Based on the key study used and its relative supporting data, the test material classify as Skin sensitisation