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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)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data from handbook or collection of data

Data source

Referenceopen allclose all

Reference Type:
other: Authoritative database
Title:
Toxicity of test chemical
Author:
IFA GESTIS
Year:
2018
Bibliographic source:
GESTIS Substance Database
Reference Type:
review article or handbook
Title:
IUCLID DATASET
Author:
EUROPEAN COMMISSION – European Chemicals Bureau
Year:
2000
Bibliographic source:
IUCLID DATASET- EUROPEAN COMMISSION – European Chemicals Bureau- 19–FEB–2000

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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
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

In vivo test system

Test animals

Species:
other: Human
Strain:
other: Not applicable
Sex:
male/female
Details on test animals and environmental conditions:
Not specified

Study design: in vivo (non-LLNA)

Induction
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
Challenge
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

Results and discussion

In vivo (non-LLNA)

Results
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

In vivo (LLNA)

Cellular proliferation data / Observations:
None of the subject induced skin sensitization.

Any other information on results incl. tables

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).

Applicant's summary and conclusion

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.