5-((4-chloro-6-((8-hydroxy-3,6-disulfo-7-((2-sulfo-4-((2(sulfooxy)ethyl)sulfonyl)phenyl)diazenyl)naphthalen-1-yl)amino)-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-((Z)-(3-sulfophenyl)diazenyl)naphthalene-2,7-disulfonic acid

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:

comparable to guideline study with acceptable restrictions

Justification for type of information:

data is from experimental report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the allergic contact sensitization potential of the given test chemical by the ear/flank method in the guinea-pig.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Currently no LLNA study is available for assessment

Test material

Test material information

Constituent 1

Reference substance name:

octasodium 2,2'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]bisnaphthalene-1,5-disulphonate

Cas Number:

68110-30-5

Molecular formula:

C58H30Cl2N14Na8O26S8

IUPAC Name:

octasodium 2,2'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]bisnaphthalene-1,5-disulphonate

Test material form:

solid

Details on test material:

Name of the test chemical: Octasodium 2,2'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino (1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]bisnaphthalene-1,5-disulphonate
Molecular formula: C58H30Cl2N14Na8O26S8
Molecular weight: 1850.3 g/mol
Smiles Notation: [Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].c1(c(cc(cc1)Nc1nc(nc(n1)Cl)Nc1cc2cc(c(c(c2cc1)O)\N=N\c1c(c2cccc(c2cc1)S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-])c1c(cc(cc1)Nc1nc(nc(n1)Cl)Nc1cc2cc(c(c(c2cc1)O)\N=N\c1c(c2cccc(c2cc1)S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-]
InChI: 1S/C58H38Cl2N14O26S8.8Na/c59-53-65-55(61-27-7-11-31-25(19-27)21-45(105(89,90)91)47(49(31)75)73-71-39-17-15-35-37(51(39)107(95,96)97)3-1-5-41(35)101(77,78)79)69-57(67-53)63-29-9-13-33(43(23-29)103(83,84)85)34-14-10-30(24-44(34)104(86,87)88)64-58-68-54(60)66-56(70-58)62-28-8-12-32-26(20-28)22-46(106(92,93)94)48(50(32)76)74-72-40-18-16-36-38(52(40)108(98,99)100)4-2-6-42(36)102(80,81)82;;;;;;;;/h1-24,75-76H,(H,77,78,79)(H,80,81,82)(H,83,84,85)(H,86,87,88)(H,89,90,91)(H,92,93,94)(H,95,96,97)(H,98,99,100)(H2,61,63,65,67,69)(H2,62,64,66,68,70);;;;;;;;/q;8*+1/p-8/b73-71+,74-72+;;;;;;;;
Substance Type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: weight range of 278 - 342 g,
- Housing: All animals were maintained in galvanized plasticized cages with solid floors
- Diet (e.g. ad libitum): complete pelleted guinea-pig diet supplemented daily with autoclaved hay, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, open

Vehicle:

N,N-dimethylformamide

Concentration / amount:

0.1 ml of 10% w/v suspension in 50% aqueous DMF

Day(s)/duration:

48 hours

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, open

Vehicle:

N,N-dimethylformamide

Concentration / amount:

0.05 ml of 10,1, 0.1% w/v suspension in 50% aqueous DMF

Day(s)/duration:

24 hours

Adequacy of challenge:

not specified

No. of animals per dose:

10
6 -test group
4- control group

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 24 hours
- Test groups: 6
- Control group: 4
- Site: outer surface of the ears
- Frequency of applications: daily for 3 days
- Duration: 24hours
- Concentrations: 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF)

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 1 day
- Exposure period: 24 hours
- Test groups: 6
- Control group: 4
- Site: clipped flanks
- Concentrations: 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF
- Evaluation (hr after challenge): 24 hours after exposure

OTHER: On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitization; that present in the controls denotes simple primary irritation.

Challenge controls:

no data available

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:

10%, 1% and 0.1% w/v suspensions in 50 0/1 aqueous DMF

No. with + reactions:

0

Total no. in group:

6

Clinical observations:

No reactions observed

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Distribution and rating of signs of skin sensitization responses among individual guinea pigs exposed to induction and challenge procedures to detect delayed contact sensitization by the test chemicalafter challenge at 0.1,1 and 10% w/v DMF

Treatment	Observations	Animal numbers											Ratio of test animals showing response on Day 7
		Test						Control
		1, male	2 male	3 male	1, female	2 female	3, female	4, male	5, male	4, female	6, female
	Bodyweight (g)
	INDUCTION	278	320	295	319	342	310	290	330	304	309
	Day 7	312	367	298	346	383	351	372	354	348	339
	Increment	34	47	3	27	41	41	82	24	44	30
Challenge, 0.1%	Erythema	0	0	0	0	0	0	0	0	0	0	0/6
Challenge, 1%	Erythema	0	0	0	0	0	0	0	0	0	0	0/6
Challenge, 10%	Erythema	0	0	0	0	0	0	0	0	0	0	0/6

No response = 0

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal body weight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.

Executive summary:

The allergic contact sensitization potential of the test chemical was assessed by the ear/flank method in the guinea-pigs. Ten Dunkin-Hartley male and female guinea-pigs were used for this test. On Days 0, 1, and 2 of the test, 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF) was applied to the outer surface of the ears of six animals only. On Day 6, 0.05 ml of 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF was applied topically to the clipped flanks of all ten animals. On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitization; that present in the controls denotes simple primary irritation. No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal bodyweight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.