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Diss Factsheets

Administrative data

Description of key information

Skin sensitization:


1. No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye. Hence, the test chemical can be considered to not sensitizing to human skin.


2. Test chemical when injected to guinea pig skin in the concentration 0.05-0.1% 10 doses in isotonic saline and challenged after 14 days produced no skin allergic reaction .Hence, the test chemical was considered to be not sensitizing to guinea pig skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Remarks:
read across data
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessement report
Qualifier:
according to guideline
Guideline:
other: Guinea pig maximisation test
Principles of method if other than guideline:
To evaluate skin sensitization potential of test chemical on guinea pig skin.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified
Specific details on test material used for the study:
- Name of test material : Food Black 2
- Molecular formula : C26H19N5O13S4.4Na
- Molecular weight : 809.651 g/mol
- Substance type: organic
- Physical state: solid
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1 ml of 0.05-0.1%
Day(s)/duration:
21 days
Adequacy of induction:
not specified
No.:
#1
Route:
other: Not specified
Vehicle:
not specified
Concentration / amount:
No data available
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
Not specified
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 doses
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Frequency of applications: 10 doses in 21 days
- Duration: 21 days
- Concentrations: 1 ml 0.05-0.1%

B. CHALLENGE EXPOSURE
- No. of exposures: Not specified
- Day(s) of challenge: 1
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Concentrations: Not specified
- Evaluation (hr after challenge ): Not specified


OTHER: Challenge was provided 14 days after induction
Challenge controls:
Not specified
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
Dose level:
1 ml 0.05-0.1%
No. with + reactions:
0
Clinical observations:
No skin allergic reactions were observed.
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: Not sensitizing
Conclusions:
Test chemical when injected to guinea pig skin in the concentration 0.05-0.1% 10 doses in isotonic saline and challenged after 14 days produced no skin allergic reaction .Hence, the test chemical was considered to be not sensitizing to guinea pig skin.
Executive summary:

The read across substance Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (CAS no.2118 -39 -0, E.C. no.: 218 -326 -9) was used as a test material to evaluate skin sensitization potential on guinea pig skin .The test material was given sub-cuteneously in the concentration 1 ml 0.05 -0.1% in isotonic saline , 10 doses for 21 days . Challenge test was provided 14 days after induction . No skin allergic reactions were observed. Hence , the test chemical was considered to be not sensitizing to guinea pig skin.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Remarks:
Read across data
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals
Qualifier:
according to guideline
Guideline:
other: Patch test
Principles of method if other than guideline:
Patch tests were performed on 312 consecutive patients to determine the allergic potential of the test chemical
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified
Species:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Department of Dermatology, University of Modena, Italy
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
5% and 10% in petrolatum
Day(s)/duration:
3 days
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
5% and 10%
Day(s)/duration:
3 days
Adequacy of challenge:
not specified
No. of animals per dose:
312 consecutive patients
119 patients were tested with 5% concentration and remaining 193 with 10% concentration
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: single exposure
- Exposure period: 3 days
- Test groups: 312
- Control group: number not mentioned
- Site: healthy skin of the back
- Frequency of applications: daily for 3 days
- Duration: 3 days
- Concentrations: 5% - 119 patients; 10% - 193 patients

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: no data available
- Exposure period: 3 days
- Test groups: 312
- Control group: no data available
- Site: healthy skin of the back
- Concentrations: 5% - 119 patients; 10% - 193 patients
- Evaluation (hr after challenge): no data available

OTHER: 312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential.
The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients.
Challenge controls:
no data available
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
3
Group:
test chemical
Dose level:
5 and 10%
No. with + reactions:
0
Total no. in group:
312
Clinical observations:
No positive allergic or irritant reactions were observed in the volunteers
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye.
Hence, the test chemical can be considered to not sensitizing to human skin.
Executive summary:

Patch tests were performed on 312 consecutive patients to determine the allergic potential of the read across substance 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS no.: 145017-98-7). 312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential. The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients. No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye. Hence, the test chemical can be considered to not sensitizing to human skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization:


 


1. Patch tests were performed on 312 consecutive patients to determine the allergic potential of the read across substance 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS no.: 145017-98-7). 312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential. The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients. No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye. Hence, the test chemical can be considered to not sensitizing to human skin.


 


2. The read across substance Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (CAS no.2118 -39 -0, E.C. no.: 218 -326 -9) was used as a test material to evaluate skin sensitization potential on guinea pig skin .The test material was given sub-cuteneously in the concentration 1 ml 0.05 -0.1% in isotonic saline , 10 doses for 21 days . Challenge test was provided 14 days after induction . No skin allergic reactions were observed. Hence , the test chemical was considered to be not sensitizing to guinea pig skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the above-summarized studies for target chemical and its structurally and functionally similar read across substances, it can be concluded that the test chemical does not cause skin sensitization thus considered a non-sensitizer. Comparing the above annotations with the criteria of CLP regulation, the test chemical does not classify as per CLP criteria.