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Administrative data

Description of key information

The skin sensitization potential of target chemical 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)  was assessedin various experimental studies which were conducted on guinea pigs and humans for target chemical2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)  and its structurally similar read across substanceBrilliant Black 1 (CAS No: 2519-30-4) andfunctionally similar read across substancesAllura Red AC dye (CAS No: 25956-17-6) and D & C Red no. 33 (CAS no: 3567-66-6). The predicted data usingQSAR toolboxhas also been compared with the experimental data.Based on the available data for the target and read across substances and applying the weight of evidence approach, it can be concluded that chemical 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)  is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data from handbook or collection of data and safety assessment report
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The skin sensitization test was conducted in guinea pigs to determine the sensitization potential of Brilliant Black 1.
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
not specified
Specific details on test material used for the study:
Name of test material (as cited in study report): Brilliant black 1 (2519-30-4)
- Molecular formula: C28-H21-N5-O14-S4.4Na
- Molecular weight: 867.6873 g/mol
- Substance type: Organic
- Physical state: Solid (Powder)
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
other: no data
Vehicle:
no data
Concentration / amount:
No data available
Day(s)/duration:
No data available
Adequacy of induction:
not specified
No.:
#1
Route:
other: no data
Vehicle:
no data
Concentration / amount:
No data available
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
no data
Details on study design:
No data available
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
Dose level:
No data available
No. with + reactions:
0
Clinical observations:
Not sensitizing
Remarks on result:
no indication of skin sensitisation
Cellular proliferation data / Observations:
No skin sensitization was observed in treated guinea pigs.

not known

Interpretation of results:
other: not sensitising
Conclusions:
The test material Brilliant Black 1 (CAS No: 2519-30-4) was considered to be non-sensitizing to the guinea pigs skin.
Executive summary:

The skin sensitization test of test chemical Brilliant Black 1 (CAS No: 2519-30-4) was carried out in guinea pigs to determine its sensitization efficacy.

Since the guinea pigs did not elicit any sensitizing effect, the test chemical Brilliant Black 1 (CAS No: 2519-30-4) was considered to be not sensitizing to the guinea pigs.

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

Various studieshas been investigated for the test chemical2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)   to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs and humans for target chemical2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)   and its structurally similar read across substanceBrilliant Black 1 (CAS No: 2519-30-4) andfunctionally similar read across substancesAllura Red AC dye (CAS No: 25956-17-6) and D & C Red no. 33 (CAS no: 3567-66-6). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data and summarized as below;

 

The skin sensitization potential of 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)   was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor. 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)   was estimated to be not sensitizing to the skin of Dunkin-Hartley guinea pigs. Based on the estimated result 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)   can be considered to be not sensitizing to Dunkin-Hartley guinea pigs.

 

The INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY (IPCS INCHEM) {Joint FAO/WHO Expert Committee on Food Additives; (WHO Food Additives Series 16; IPCS INCHEM; 1975} and EFSA {EFSA Journal 2010;8(4):1540} reported skin sensitization study on read across chemical Brilliant Black 1 (CAS No: 2519-30-4)in guinea pigs.Since the guinea pigs did not elicit any sensitizing effect, the test chemicalBrilliant Black 1 (CAS No: 2519-30-4)was considered to be not sensitizing to the guinea pigs.

 

The above results were further supported by the prophetic patch test performed by IPCS INCHEM {Allura red AC (WHO Food Additives Series 15); IPCS INCHEM; 1981} on 200 human subjects for read across chemical Allura Red AC dye (CAS No: 25956-17-6). The chemical Allura Red was applied either as a neat or as a 25% aqueous solution to the skin of 200 human subjects. The initial exposure to the compound was for 72 hours, and this was followed by a 24-hour application 10 to 14 days later. None of the subjects exhibited compound induced irritation. Hence the chemical Allura Red AC dye (CAS No: 25956-17-6) was considered to be not irritating to the skin of 200 human subjects in a prophetic patch test.

 

The above results were further supported by the Maximization test reported by Scientific Committee on Consumer Safety (SCCS){ Opinion on Acid Red 33 ,Scientific Committee on Consumer Safety (SCCS), SCCP/1102/07} in female 15 (10 test and 5 control)Guinea pig for read across chemical D & C Red no. 33 (CAS no: 3567-66-6). The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction. The test areas are pretreated with 10 sodium-laureth-sulfates (SLS) 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No known skin sensitization reactions were observed in treated as well as control group. Hence the chemical D& C Red no. 33 (CAS no: 3567-66-6) was considered to be not sensitizing.

 

Thus on the basis of available data for thetarget chemical2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)   and its structurally similar read across substanceBrilliant Black 1 (CAS No: 2519-30-4) andfunctionally similar read across substancesAllura Red AC dye (CAS No: 25956-17-6) and D & C Red no. 33 (CAS no: 3567-66-6),it can be concluded thatchemical 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)   is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)    and its structurally similar read across substanceBrilliant Black 1 (CAS No: 2519-30-4) andfunctionally similar read across substancesAllura Red AC dye (CAS No: 25956-17-6) and D & C Red no. 33 (CAS no: 3567-66-6)were observed in various studies. From the results obtained from these studies it is concluded that the chemical 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS No: 93941-74-3)   is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.