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Description of key information

The results of the experimental studies from the various test chemicals indicate a possibility that the test chemical can be not sensitizing to skin.

Hence, by applying the weight of evidence approach,the test chemical can be considered to 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:
data from handbook or collection of data
Remarks:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on various test chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on various test chemicals
Justification for non-LLNA method:
Not specified
Specific details on test material used for the study:
- IUPAC Name: 2-[[6-[[4-Chloro-6-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3-sulfo-2-naphthalenyl]azo]-1,5-naphthalenedisulfonic acid tetrasodium salt
- Mol. formula: C31H20ClN7Na4O16S5
- Molecular Weight: 1034.275 g/mole
- InChI: 1S/C31H24ClN7O16S5.4Na/c32-29-35-30(33-17-4-7-19(8-5-17)56(41,42)13-12-55-60(52,53)54)37-31(36-29)34-18-6-9-20-16(14-18)15-25(58(46,47)48)26(27(20)40)39-38-23-11-10-21-22
(28(23)59(49,50)51)2-1-3-24(21)57(43,44)45;;;;/h1-11,14-15,40H,12-13H2,(H,43,44,45)(H,46,47,48)(H,49,50,51)(H,52,53,54)(H2,33,34,35,36,37);;;;/q;4*+1/p-4/b39-38+;;;;
- Smiles:c1cc2c(ccc(c2S(=O)(=O)[O-])N=Nc3c(cc4cc(ccc4c3O)Nc5nc(nc(n5)Cl)Nc6ccc(cc6)S(=O)(=O)CCOS(=O)(=O)[O-])S(=O)(=O)[O-])c(c1)S(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+]
Species:
other: 1,2. humans
Strain:
not specified
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Day(s)/duration:
10 alternate days, for 24-hour periods
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
20% in water
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Day(s)/duration:
24 hours.
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
20% in water
Adequacy of challenge:
not specified
No. of animals per dose:
1. 200 human
2. 15 patients
Details on study design:
The data is based on weight of evidence approach based on various test chemicals
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Clinical observations:
no signs of sensitization observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
Executive summary:

The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical .In this study, the chemical applied to the subject’s volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours.

The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.

Therefore the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.

This is supported by the results of Patch tests performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. 20% dye in water was applied on the skin of 15 patients in Finn Chambers. The skin reactions were 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. Hence, the test chemical can be considered as non sensitizer to human skin.

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

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

The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical .In this study, the chemical applied to the subject’s volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours.

The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.

Therefore the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.

This is supported by the results of Patch tests performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. 20% dye in water

was applied on the skin of 15 patients in Finn Chambers. The skin reactions were 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. Hence, the test chemical can be considered as non sensitizer to human skin.

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

 

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The results of the experimental studies from the various test chemicals indicate a possibility that the test chemical can be not sensitizing to skin.

Hence, by applying the weight of evidence approach,the test chemical can be considered to be not sensitizing to skin.