Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate

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:

data from handbook or collection of data

Justification for type of information:

Data is from review article and safety assessment report

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Ethylenebis(tetrabromophthalimide) [CASRN 32588-76-4] Review of Toxicological Literature

Author:

NTP; National Institute of Environmental Health Sciences

Year:

1999

Bibliographic source:

NTP; National Institute of Environmental Health Sciences; October 1999

Reference 2

Reference Type:

secondary source

Title:

PRIMARY SKIN IRRITATION STUDY- RABBITS WITH COVER LETTER DATED 030890

Author:

NTRL REPORT

Year:

1990

Bibliographic source:

NTRL REPORT - OTS0522918; 13 MARCH 1990

Materials and methods

Principles of method if other than guideline:

The dermal irritation study of Ethylenebis(tetrabromophthalimide) (CAS No: 32588-76-4) was conducted on albino rabbits to determine the degree of irritation.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-ethane-1,2-diylbis(4,5,6,7-tetrabromo-1H-isoindole-1,3(2H)-dione)

Cas Number:

32588-76-4

Molecular formula:

C18H4Br8N2O4

IUPAC Name:

2,2'-ethane-1,2-diylbis(4,5,6,7-tetrabromo-1H-isoindole-1,3(2H)-dione)

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Ethylene bis(tetrabromophthalimide)
- Molecular formula): C18H4Br8N2O4
- Molecular weight: 951.472 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles:c12c(C(=O)N(C1=O)CCN1C(c3c(c(Br)c(c(c3C1=O)Br)Br)Br)=O)c(c(Br)c(c2Br)Br)Br
-InChI:1S/C18H4Br8N2O4/c19-7-3-4(8(20)12(24)11(7)23)16(30)27(15(3)29)1-2-28-17(31)5-6(18(28)32)10(22)14(26)13(25)9(5)21/h1-2H2

Specific details on test material used for the study:

- Name of test material (as cited in study report): Ethylene bis(tetrabromophthalimide)
- Molecular formula): C18H4Br8N2O4
- Molecular weight: 951.472 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles:c12c(C(=O)N(C1=O)CCN1C(c3c(c(Br)c(c(c3C1=O)Br)Br)Br)=O)c(c(Br)c(c2Br)Br)Br
-InChI:1S/C18H4Br8N2O4/c19-7-3-4(8(20)12(24)11(7)23)16(30)27(15(3)29)1-2-28-17(31)5-6(18(28)32)10(22)14(26)13(25)9(5)21/h1-2H2

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

No data available

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

intact and abraded site

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

500mg

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours

Number of animals:

6

Details on study design:

- Area of exposure: the trunk of the animal
- Type of wrap if used: The sites were covered with gauze pads and an impervious material was wrapped around the trunk of the animal to hold the pads in place

SCORING SYSTEM: The Draize method

Results and discussion

In vivo

Results

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 erythema, eschar, or edema formation occurred at 24 or 72 hours.

Any other information on results incl. tables

Table: 1:Primary skin irritation
Erythema and eschar formation	Reading (Hours)	Rabbit number						Average
		1	2	3	4	5	6
Intact skin	24	0	0	0	0	0	0	0.00
Intact skin	72	0	0	0	0	0	0	0.00
Abraded skin	24	0	0	0	0	0	0	0.00
Abraded skin	72	0	0	0	0	0	0	0.00
Subtotal								0.00
Edema formation
Intact skin	24	0	0	0	0	0	0	0.00
Intact skin	72	0	0	0	0	0	0	0.00
Abraded skin	24	0	0	0	0	0	0	0.00
Abraded skin	72	0	0	0	0	0	0	0.00
Subtotal								0.00
Total								0.00
PRIMARY IRRITATION SCORE: 0

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

The test material Ethylenebis(tetrabromophthalimide) (CAS No: 32588-76-4) was considered to be not irritating to the skin of albino rabbits.

Executive summary:

The dermal irritation study of Ethylenebis(tetrabromophthalimide) (CAS No: 32588-76-4) was conducted on albino rabbits to determine the degree of irritation.

 

In this study, 500 mg of Ethylenebis(tetrabromophthalimide) was applied to the abraded skin of three rabbits and the intact skin of the other three over the wide shaved area. One side of each rabbit’s back was slightly abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not to enter the derma and produce bleeding. The other side of the back was left intact.

 

The sites were covered with gauze pads and an impervious material was wrapped around the trunk of the animal to hold the pads in place. The dressing was removed at 24 hours and 72 hours in order to observe the sites.the skin reactions were observed according toDraize method.

 

None of the treated rabbit produced erythema, eschar, or edema at 24 or 72 hours with primary irritation index of 0. Hence the chemical Ethylenebis(tetrabromophthalimide) (CAS No: 32588-76-4)was considered to be not irritating to the skin of albino rabbits.