Dipotassium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from safety assessment reports

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

OECD SIDS - C.I. FLUORESCENT BRIGHTENER 28/113

Author:

OECD SIDS

Year:

2005

Bibliographic source:

SIDS Initial Assessment Report For SIAM 20, Paris, April 19-22, 2005

Reference 2

Reference Type:

secondary source

Title:

Mucous membrane compatibility of the rabbit eye Blankophor BA 267% for a single application.

Author:

Bayer AG

Year:

1979

Bibliographic source:

Study reported from the laboratory of Pharmacology and Toxicology dated to Bayer AG 1979-06-15.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the ocular irritation potential of disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate (CAS No: 4193-55-9) in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate

EC Number:

224-073-5

EC Name:

Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate

Cas Number:

4193-55-9

Molecular formula:

C40H44N12O10S2.2Na

IUPAC Name:

disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate

Test material form:

solid

Details on test material:

- Name of the test material: disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
Common Name: Blankophor BA
- Molecular Formula: C40H44N12O10S2.2Na
- Molecular Weight: 960.9578 g/mol
- Substance type: Organic
- Physical State: Solid

Specific details on test material used for the study:

- Name of the test material: disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
Common Name: Blankophor BA
- Molecular Formula: C40H44N12O10S2.2Na
- Molecular Weight: 960.9578 g/mol
- Substance type: Organic
- Physical State: Solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test animal:
Weight: 2.3-2.8 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

eyelids were closed for 1 second

Observation period (in vivo):

the eyes were observed before treatment and after 24, 48 and 72 hours and 7 days after instillation of test chemical

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

Total 6 animals (3 males, 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: The reactions were scored according to Draize 24,48 and 72 hours after application

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: fluorescein
After 24 hours, the eyes were also inspected with fluorescein.

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No eye reactions were observed (score 0) as well as no clinical signs were noted.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

No eye reactions as well no clinical signs were observed through out the study.
The Irritation Score was 0. Based on the scores and observations, disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate (CAS No: 4193-55-9) can be consdiered not irritating to eyes.

Executive summary:

The ocular irritation potential of disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate (CAS No: 4193-55-9) was assessed in rabbits.

New Zealand White rabbits (3/sex) were administered C.I. Fluorescent Brightener 28, disodium salt by the instillation of 100 mg into one eye. The eyelids were held closed for 1 second. The eyes were examined 24, 48 and 72 hours and 7 days following application. Examination at 24 hours was aided with fluorescein dye.

No eye reactions as well no clinical signs were observed through out the study.

The Irritation Score was 0. Based on the scores and observations, disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate (CAS No: 4193-55-9) can be considered not irritating to eyes.