Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

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 journal.

Data source

Reference

Reference Type:

publication

Title:

Final report on the safety assessment of EDTA, calcium disodium EDTA, diammonium EDTA, dipotassium EDTA, disodium EDTA, TEA-EDTA, tetrasodium EDTA, tripotassium EDTA, trisodium EDTA, HEDTA, and trisodium HEDTA.

Author:

Cosmetic Ingredient Review Expert Panel

Year:

2002

Bibliographic source:

International Journal of Toxicology [01 Jan 2002, 21 Suppl 2:95-142]

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Skin sensitisation study of Disodium EDTA (CAS no: 139-33-3) was assessed in five male guinea pigs to determine its sensitization potential by using intracutaneous application.

GLP compliance:

not specified

Type of study:

not specified

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium dihydrogen ethylenediaminetetraacetate

EC Number:

205-358-3

EC Name:

Disodium dihydrogen ethylenediaminetetraacetate

Cas Number:

139-33-3

Molecular formula:

C10H14N2Na2O8

IUPAC Name:

disodium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Disodium EDTA
- Molecular formula: C10H16N2O8.2Na
- Molecular weight: 336.207 g/mol
- Substance type: organic
- Physical state:solid
- Smiles: C([N@@](CC(O)=O)CC(=O)[O-])C[N@@](CC(O)=O)CC(=O)[O-].[Na+].[Na+]
- InChI: 1S/C10H16N2O8.2Na/c13-7(14)3-11(4-8(15)16)1-2-12(5-9(17)18)6-10(19)20;;/h1-6H2,(H,13,14)(H,15,16)(H,17,18)(H,19,20);;/q;2*+1/p-2.

Specific details on test material used for the study:

- Name of test material (as cited in study report): Disodium EDTA
- Molecular formula: C10H16N2O8.2Na
- Molecular weight: 336.207 g/mol
- Substance type: organic
- Physical state:solid
- Smiles: C([N@@](CC(O)=O)CC(=O)[O-])C[N@@](CC(O)=O)CC(=O)[O-].[Na+].[Na+]
- InChI: 1S/C10H16N2O8.2Na/c13-7(14)3-11(4-8(15)16)1-2-12(5-9(17)18)6-10(19)20;;/h1-6H2,(H,13,14)(H,15,16)(H,17,18)(H,19,20);;/q;2*+1/p-2.

In vivo test system

Test animals

Species:

guinea pig

Sex:

male

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Concentration / amount:

0.1ml (1st intraderadermal injection)
0.2ml (9 volume on alternate days)

Challenge

Route:

intradermal

Concentration / amount:

0.1ml

Day(s)/duration:

24 hours

No. of animals per dose:

5

Details on study design:

Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:10
- Exposure period: no data
- Test groups: 5
- Control group: no data
- Site: intracutaneous
- Frequency of applications: total 10 applications on alternate days
- Duration:
- Concentrations: 0.1ml(1st intraderadermal injection)
0.2ml (9 volume on alternate days)

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:2 weeks after last induction
- Exposure period: 24 hours
- Test groups:5
- Control group: no data
- Site: intracutaneous
- Concentrations: 0.1ml
- Evaluation (hr after challenge): after 24 hours

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1ml

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

No signs of allergic reactions were observed in treated animals.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

The test material Disodium EDTA (CAS no: 139-33-3) was considered to be not sensitizing to the skin of guinea pigs when injected intracutaneous.

Executive summary:

Skin sensitization study of Disodium EDTA (CAS no: 139-33-3) was assessed in five male guinea pigs to determine its sensitization potential by using intracutaneous application.

 

During induction, each guinea pig revied 0.1 ml and then 9 volumes of 0.2 ml Disodium EDTA intacutaneously on alternate days. After 2 weeks of last induction injection, animals were challenged intradermally with 0.1ml of Disodium EDTA for 24 hours. Skin reactions were evaluated after 24 hours.

 

None of the guinea pig had showed any signs of allergic reaction. Therefore Disodium EDTA (CAS no: 139-33-3) was considered to be not sensitizing to the skin of guinea pigs when injected intracutaneous.