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 irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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: method described in the 'Code of Federal Regulations', Title 15, Section 1500.41

Principles of method if other than guideline:

To predict the potential for inflammatory or corrosive activity in single, occluded, primary contact of the test chemical with the skin of the rabbit

GLP compliance:

not specified

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: male
- Weight at study initiation: 2.5 - 3.5 kg bodyweight
- Housing:were housed individually in suspended galvanized and stainless steel cages (from Cope and Cope Ltd.), measuring 0.6 x 0.6 x 0.4 m high and fitted with mesh floors and automatic watering
- Diet (e.g. ad libitum): complete pelleted rabbit diet; Diet RAG modified, from Labsure Animal Foods, Poole, Dorset; ad libitum
- Water (e.g. ad libitum): water; ad libitum
- Acclimation period:All rabbits were held for a minimum period of seven days before entering the study.
- Identification: Each animal was weighed and allocated by random selection to the appropriate test group, in which it was identified by numbered ear-tag.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature was controlled within the range 15 0 ± 2 0 C
- Photoperiod (hrs dark / hrs light):lighting was restricted to 14 hours in each period of 24 hours

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

0.5 g moistened with water

Duration of treatment / exposure:

24 hours

Observation period:

24,48 and 72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: back
- % coverage: a square patch of surgical gauze measuring 2.5 cm x 2.5 cm
- Type of wrap if used: The entire trunk of the animal is then wrapped with an impervious material such as rubber or PVC (after ensuring that the test substance does not react chemically with the rubber or PVC)


OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation: Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

8

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

8

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No responses were detected and a Primary Irritation Index of zero was obtained

Any other information on results incl. tables

Scoring of irritance responses elicited by single dermal occlusive applications to the dorsum of rabbits

Animal number, sex	Type of response	Score at 24 hours		Score at 72 hours		Overall score	Score at day 7
		Intact skin	Abraded skin	Intact skin	Abraded skin		Intact skin	Abraded skin
323, Male	Erythema	0	0	0	0	0	0	0
	edema	0	0	0	0	0	0	0
325, male	Erythema	0	0	0	0	0	0	0
	edema	0	0	0	0	0	0	0
326, male	Erythema	0	0	0	0	0	0	0
	edema	0	0	0	0	0	0	0
328, male	Erythema	0	0	0	0	0	0	0
	edema	0	0	0	0	0	0	0
328, male	Erythema	0	0	0	0	0	0	0
	edema	0	0	0	0	0	0	0
329, male	Erythema	0	0	0	0	0	0	0
	edema	0	0	0	0	0	0	0
330, male	Erythema	0	0	0	0	0	0	0
	edema	0	0	0	0	0	0	0

Primary Irritation Score = 0

Overall Irritation Score = 0

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The test chemical was assessed for primary irritation to the skin of rabbits according to the Ecological and Toxicological Association of Dyestuffs Manufacturers (ETAD) test based upon the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41.
Under the test conditions employed, the test chemical produced a Primary Irritation Index within the range 0.0 - 0.5 and was thus classified 'non-irritant' to skin.

Executive summary:

A study was conducted according to the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41 to predict the potential for inflammatory or corrosive activity in single, occluded, primary contact of the test chemical with the skin of the rabbit. 6 albino male New Zealand White rabbits were used for the study. The rabbits were fed standard pelleted rabbit diet and water, ad libitum and housed in metal cages throughout the study. Before intended application, both sides of the back were clipped as close to the skin as possible using electric clippers (chemical depilatories were not used). Two to three hours later, abrasions were made to the upper third of one side of the back (flank area behind the ribs). The abrasions were made by using the back of the point of a scalpel blade to scratch a 5 x 5 lattice in an area measuring 2.5cm2 , such that only the stratum corneum was penetrated and bleeding did not occur. 0.5 g of powder were prepared as a paste by addition of a minimal volume of water.One application is made to the skin area previously abraded and one application is made to the intact skin in the corresponding position on the other side of the back. The entire trunk of the animal is then wrapped with an impervious material such as rubber or PVC (after ensuring that the test substance does not react chemically with the rubber or PVC) for the 24-hour period of exposure. The animal was not immobilised but the patches are held in place using bandages or elasticated stockingette. After the 24-hour exposure, the patches are removed and the reactions evaluated without washing the application site The dermal reactions were observed and scored at 24,48 and 72 hours according to the method of Draize. No responses were detected and a Primary Irritation Index of zero was obtained.It was thus classified under the category "Not Classified".