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Description of key information

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal sensitization  potential for target substance.The test chemical was estimated be not sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Weight of evidence based on structurally similar read across chemicals
Justification for type of information:
Weight of evidence based on structurally similar read across chemicals
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: Weight of evidence based on structurally similar chemicals
Principles of method if other than guideline:
The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization potential of Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl] azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate
GLP compliance:
not specified
Type of study:
other: Weight of evidence based on structurally similar chemicals
Specific details on test material used for the study:
- Name of test material: Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino] -2-sulphonatophenyl]azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate
- IUPAC name: Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl] azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate
- Molecular formula: C30H27ClN8O17S5.4Na
- Molecular weight: 1055.29 g/mole
- Smiles :[Na+].[Na+].[Na+].[Na+].c1c(c(c(c2c(cc(cc12)S(=O)(=O)[O-])NC(CC)=O)O)\N=N\c1c(ccc(c1)Nc1nc(nc(n1)Cl)Nc1cc(ccc1)S(=O)(=O) CCOS(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-]
- Inchl: 1S/C30H27ClN8O17S5.4Na/c1-2-24(40)34-21-14-19(58(44,45)46)10-15-11-23(60(50,51)52)26(27(41)25(15)21)39-38-20-13-17(6-7-22(20) 59(47,48)49)33-30-36-28(31)35-29(37-30)32-16-4-3-5-18(12-16)57(42,43)9-8-56-61(53,54)55;;;;/h3-7,10-14,41H,2,8-9H2,1H3,(H,34,40)(H,44,45,46)(H,47,48,49)(H,50,51,52)(H,53,54,55)(H2,32,33,35,36,37);;;;/q;4*+1/p-4/b39-38+;;;;
- Substance type: Organic
- Physical state: Solid crystalline
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data available
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
2 times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline
Adequacy of induction:
not specified
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
intradermal induction: 5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline
Epidermal induction: 25% dilution in 1% CMC
Day(s)/duration:
1 week and 18 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
single intradermal injection of a 3% solution in saline
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, open
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
25% dilution in 1% CMC
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
The study is based on weight of evidence approach from the read across values
Challenge controls:
The study is based on weight of evidence approach from the read across values
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
Clinical observations:
no dermal reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal sensitization  potential for target substance.The test chemical was estimated be not sensitizing to skin.
Executive summary:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal sensitization potential for target substance.

 

Guinea pig Maximization assay was conducted to determine the sensitization potential of the structurally similar read across chemical. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted.

In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs.

Signs of sensitization were not observed. Hence, the test chemical was considered to be non sensitizing after challenge exposure in guinea pig.

The above result is supported by a study conducted as per OECD 406 Guidelines performed on guinea pigs to assess the dermal sensitization potential of the structurally similar read across chemical.

The intradermal induction of sensitisation 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 sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (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 skin sensitization reaction was observed.

Hence the test chemical was considered to be not skin sensitizing in guinea pig.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across chemicals. Therefore the target chemical was estimated to be not sensitizing to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

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

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal sensitization potential for target substance.

 

Guinea pig Maximization assay was conducted to determine the sensitization potential of the structurally similar read across chemical. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted.

In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs.

Signs of sensitization were not observed. Hence, the test chemical was considered to be non sensitizing after challenge exposure in guinea pig.

The above result is supported by a study conducted as per OECD 406 Guidelines performed on guinea pigs to assess the dermal sensitization potential of the structurally similar read across chemical.

The intradermal induction of sensitisation 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 sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (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 skin sensitization reaction was observed.

Hence the test chemical was considered to be not skin sensitizing in guinea pig.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across chemicals. Therefore the target chemical was estimated to be not sensitizing to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The results of the experimental studies from the structurally similar read across substances indicate a possibility that Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl] azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate can be not sensitizing to skin.

Hence by applying the weight of evidence approach, Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl] azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.