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

Eye irritation

Administrative data

Endpoint:

eye 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 artcle 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:

ACUTE EYE IRRITATION TEST IN RABBITS WITH ATTACHMENTS AND COVER LETTER DATED 030890

Author:

NTRL REPORT

Year:

1990

Bibliographic source:

NTRL REPORT - OTS0522916; 13 MARCH 1990

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

An eye irritation study of Ethylenebis(tetrabromophthalimide) (CAS No: 32588-76-4) was conducted on New Zealand albino rabbits to determine the degree of irritation produced by the test substance .

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Details on test animal
TEST ANIMALS
- Weight at study initiation: 2 – 3 kg
- Fasting period before study:
- Housing: Rabbits were housed individually in cages sized in accordance with the guide for the care and use of laboratory animals’ of the institute of laboratory resources, National research council.
- Diet (e.g. ad libitum): wayne rabbit ration, ad libitum, checked daily and added or replaced as needed.
- Water (e.g. ad libitum): fresh tap water, fit for human consumption,ad libitum.
- Acclimation period: 5 Days


ENVIRONMENTAL CONDITIONS
- Temperature (°C):20°C ± 3°C
- Humidity (%):30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Vehicle:

not specified

Controls:

yes

Amount / concentration applied:

100mg/eye

Duration of treatment / exposure:

7 days

Observation period (in vivo):

1, 24, 48, and 72 hours and finally at day 7

Number of animals or in vitro replicates:

6 (3/sex)

Details on study design:

- Area of exposure: the conjunctival sac of right eye of each rabbit.

SCORING SYSTEM: according to Draize method.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Post-exposure positive responses occurred in all six rabbits at 1 hour, 2 rabbits at 24 hours, and none from 48 hours until the end of the study. Only the conjunctivae were affected. All observed effects were cleared upto 7 days.

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 eyes of albino New Zealand rabbits over a 7 days observation period .

Executive summary:

An eye irritation study of Ethylenebis(tetrabromophthalimide) (CAS No: 32588-76-4) was conducted on six (3/sex) albino New Zealand rabbits to determine the degree of irritation produced by the test substance .

 

 About 100mg of Ethylenebis(tetrabromophthalimide) was installed into theconjunctival sac of right eye of each rabbit.24 hours prior to the application of the test material, the eyes of the rabbits were examined using 2% sodium fluorescein stain. Animals showing preexisting corneal injury were eliminated from the study. The left untreated eye served as control.

 

The animals were observed for ocular lesions according to Draize scoring system at 1, 24, 48, and 72 hours and finally at day 7, when the study was terminated.

 

Post-exposure positive responses occurred in all six rabbits at 1 hour, 2 rabbits at 24 hours, and none from 48 hours until the end of the study. Only the conjunctivae were affected.

 

Ethylenebis(tetrabromophthalimide) received a Draize score of 3.0 at 1 hour, 0.3 at 72 hours and 0.0 at 7 days after exposure (maximum score =110).

 

Since all the observed ocular lesions were cleared during 7 days post exposure period, Ethylenebis(tetrabromophthalimide) (CAS No: 32588-76-4)was considered to be not irritating to the eyes of albino New Zealand rabbit.