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Administrative data

Description of key information

The skin sensitization potential of target chemical Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate/D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) was assessedin various experimental studies which were conducted on humans for target chemicalCalcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate/D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) andits structurally similar read across substances.Based on the available data for the target and read across substances, it can be concluded that chemical Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate/D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) 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: in vivo (non-LLNA)
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
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A patch test was conducted on 25 healthy subjects to assess the skin sensitization potential of test chemical D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9).
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified
Specific details on test material used for the study:
- IUPAC Name: calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate- Common Name: D & C Red no. 7- InChI:1S/C18H14N2O6S.Ca/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;- Smiles:c12c(c(c(C(=O)[O-])cc1cccc2)O)\N=N\c1c(cc(C)cc1)S(=O)(=O)[O-].[Ca+2]- Name of test material (as cited in study report):C. I. Pigment 57:1- Molecular formula :C18H12CaN2O6S- Molecular weight :424.445 g/mol- Substance type:organic- Physical state:solid
Species:
other: Human
Strain:
other: Not applicable
Sex:
male/female
Details on test animals and environmental conditions:
Not specified
Route:
epicutaneous, occlusive
Vehicle:
other: talc
Concentration / amount:
50% lithol rubine BK mixed with talc
Day(s)/duration:
48 hours
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: talc
Concentration / amount:
50% lithol rubine BK mixed with talc
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
25 human subjects
Details on study design:
MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 5- Exposure period: 48 hours- Test groups: 25 subjects- Control group: no data- Site: sebum to their skin - Frequency of applications: no data - Duration:48 hours- Concentrations: 50% lithol rubine BK mixed with talcB. CHALLENGE EXPOSURE- No. of exposures: 1- Day(s) of challenge: after 10-14 days of rest period- Exposure period: 1- Test groups:25 subjects - Control group: no data- Site: no data - Concentrations: 50% lithol rubine BK mixed with talc- Evaluation (hr after challenge): after 48 hours
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50% lithol rubine BK mixed with talc
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
None of the subject induced skin sensitization.
Remarks on result:
no indication of skin sensitisation
Cellular proliferation data / Observations:
None of the subject induced skin sensitization.

The subjects were given five 48 hour covered patch tests with the TS,(each separated by a 24 hour period with aqueous sodium lauryl sulphate).

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) was considered to be not irritating to the skin of 25 human subjects.
Executive summary:

A patch test was conducted on 25 healthy subjects to assess the skin sensitization potential of test chemicalD&C Red 7/ Lithol rubine BK (CAS No:5281-04-9).

 

In induction phase, eachsubjects were given five 48 hour covered patch test of 50% lithol rubine BK mixed with talc (each separated by a 24 hour period with aqueous sodium lauryl sulphate).

 

After a rest period of 10-14 days, the subjects were challenged for 48 hours using the same concentration and later observed for allergic reactions.

 

Since none of the treated volunteer had developed skin sensitization, the test chemicalD&C Red 7/ Lithol rubine BK (CAS No:5281-04-9) was considered to be not sensitizing to the skin of treated volunteers.

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

Various studieshas been investigated for the test chemicalCalcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate/D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9)to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in humans for target chemicaland its structurally similar read across chemicals which have beensummarized as below;

 

A patch test was conducted by authoritative database on 25 healthy subjects to assess the skin sensitization potential of test chemicalD&C Red 7/ Lithol rubine BK (CAS No:5281-04-9). In induction phase, eachsubject was given five 48 hour covered patch test of 50% lithol rubine BK mixed with talc (each separated by a 24 hour period with aqueous sodium lauryl sulphate).After a rest period of 10-14 days, the subjects were challenged for 48 hours using the same concentration and later observed for allergic reactions.Since none of the treated volunteer had developed skin sensitization, the test chemicalD&C Red 7/ Lithol rubine BK (CAS No:5281-04-9) was considered to be not sensitizing to the skin of treated volunteers.

 

The above result was further supported by the patch test conducted by the peer reviewed journal for twostructurally similar read across substancesto determine the allergic contact dermatitis caused by the chemicals on human patients. These patch tests were conducted on 15 patients for chemical D & C Red No. 6 (CAS no: 5858-81-1) while for chemicalD&C Red 36(CAS no: 2814-77-9) this test was conducted on 14 patients. Each dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories. None of the treated patients showed any signs of allergic contact dermatitis for both the chemicals. Hence the chemicals D & C Red No. 6 (CAS no: 5858-81-1) andD&C Red 36(CAS no: 2814-77-9) can be considered as non-sensitizer to human skin.

 

Based on the available data for thetarget chemicalCalcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate/D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) and its structurally similar read across substances,it can be concluded thatchemical Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate/D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) is unable to cause skin sensitization and considered as non-sensitizing . 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 Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate/D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) and its structurally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate/D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.