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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 Type:

secondary source

Title:

Screening-Level Hazard Characterization Chemical Category, Stilbene Fluorescent Brighteners

Author:

SIDS INITIAL ASSESSMENT PROFILE

Year:

2010

Bibliographic source:

U.S. Environmental Protection Agency, Hazard Characterization Document, 2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the dermal irritation potential of Blankophor BA 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

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data available

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact or scarified skin

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

C.I. Fluorescent Brightener 28, disodium salt in water at 50%

Duration of treatment / exposure:

24 hours

Observation period:

14-day

Number of animals:

6/group

Details on study design:

No data available

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hrs, 14days

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of skin irritation were observed.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

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 not irritating to rabbit skin after 7 days of observation.

Executive summary:

A dermal irritation study was performed to assess the 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 (Blankophor BA) (CAS No: 4193-55-9) in rabbits.

Two New Zealand White rabbits were exposed to 500 mg of Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate, free acid as a dry powder applied to the inner surface the ears and covered with adhesive bandages for 24 hours. The ears were rinsed following exposure and the rabbits were observed for 7 days. No signs of skin irritation were observed.

Hence, 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 rabbit skin.