Registration Dossier

Administrative data

Description of key information

Skin sensitisation

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

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:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization test was conducted on guinea pigs and humans to determine the potential of skin sensitization caused by the chemical.
GLP compliance:
not specified
Type of study:
other: not specified
Justification for non-LLNA method:
not specified
Specific details on test material used for the study:
- Name of test material: barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
- Molecular formula: C18H14N2O6S.Ba
- Molecular weight: 521.697 g/mol
- Smiles notation: [Ba+2].c1c(c(c(c2ccccc12)\N=N\c1c(cc(cc1)C)S(=O)(=O)[O-])O)C(=O)[O-]
- InChl: 1S/C18H14N2O6S.Ba/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+;
- Substance type: Organic
- Physical State: Solid
Species:
other: 2. humans 3. guinea pig
Strain:
other: 2. not applicable 3. Ibm: GOHI
Sex:
female
Details on test animals and environmental conditions:
2. not specified
3. No data available
Route:
other: epicutaneous
Vehicle:
water
Remarks:
2
Concentration / amount:
20%
Day(s)/duration:
7 days
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
other: 1% CMC and in an emulsion of FCA/physiological saline
Remarks:
3
Concentration / amount:
intradermal induction: 5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline
Day(s)/duration:
no data available
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
epicutaneous, occlusive
Vehicle:
other: 1% CMC and in an emulsion of FCA/physiological saline
Remarks:
3
Concentration / amount:
Epidermal induction: 25% dilution in 1% CMC
Day(s)/duration:
18 hours
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
other: epicutaneous
Vehicle:
water
Remarks:
2
Concentration / amount:
20%
Day(s)/duration:
7 days
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: 1% CMC and in an emulsion of FCA/physiological saline
Remarks:
3
Concentration / amount:
Challenge: 25% dilution in 1% CMC
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
2. Total = 15 patients
3. Total:15 female Test group:10 control group:5
Details on study design:
2. The 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.
3. RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 18hr
- Test groups: 10
- Control group: 5
- Site: nuchal region
- Frequency of applications: On day 1 and 8
- Duration: 1 week
- Concentrations:for the intradermal induction: 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline.
For epidermal induction :25% in 1% CMC

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 24hr
- Test groups: 10
- Control group: 5
- Site: nuchal region
- Concentrations: 25% in 1% CMC
- Evaluation (hr after challenge): 24 and 48 hr

OTHER : The pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item during epidermal induction. 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.
Challenge controls:
2. no data available
3. yes
Positive control substance(s):
yes
Remarks:
2. not specified 3. 2-mercaptobenzothiazole
Reading:
1st reading
Hours after challenge:
168
Group:
test group
Dose level:
20%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
None of the treated patients showed allergic contact dermatitis.
Remarks on result:
no indication of skin sensitisation
Remarks:
2
Reading:
1st reading
Hours after challenge:
24
Group:
other: vehicle control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
non sensitizer in Control Group
Remarks on result:
no indication of skin sensitisation
Remarks:
3
Reading:
2nd reading
Hours after challenge:
48
Group:
other: vehicle control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
non sensitizer in Control Group
Remarks on result:
no indication of skin sensitisation
Remarks:
3
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
non sensitizer in Test Group
Remarks on result:
no indication of skin sensitisation
Remarks:
3
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
non sensitizer in Test Group
Remarks on result:
no indication of skin sensitisation
Remarks:
3
Interpretation of results:
other: Not sensitizing
Conclusions:
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Executive summary:

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. The dye was applied on15 patients 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. Hence, the test chemical can be considered as non sensitizer to human skin.

 

The above study was supported with another Maximization test performed on guinea pigs to assess the dermal sensitization potential of the test chemical. The study was conducted in accordance with OECD 406 Guidelines. 15 female guinea pigs were used for the study (10 -test group, 5- control group). The intradermal induction of sensitization 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 sensitization 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 result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

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

Skin sensitization

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. The dye was applied on15 patients 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. Hence, the test chemical can be considered as non sensitizer to human skin.

 

The above study was supported with another Maximization test performed on guinea pigs to assess the dermal sensitization potential of the test chemical. The study was conducted in accordance with OECD 406 Guidelines. 15 female guinea pigs were used for the study (10 -test group, 5- control group). The intradermal induction of sensitization 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 sensitization 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 result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.