Trisodium 4-[[1-hydroxy-6-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]-3-sulphonato-2-naphthyl]azo]benzoate

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 report.

Data source

Reference

Reference Type:

secondary source

Title:

Human & Environmental Risk Assessment on ingredients of European household cleaning products Substance: Fluorescent Brightener FWA-5 (CAS 27344-41-8)

Author:

Human & Environmental Risk Assessment on ingredients of European household cleaning products Substance

Year:

2003

Bibliographic source:

HERA targeted risk assessment of FWA-5, May, 2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

To evaluate skin irritation potential of Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate on New Zealand White rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)

EC Number:

248-421-0

EC Name:

Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)

Cas Number:

27344-41-8

Molecular formula:

C28H22O6S2.2Na

IUPAC Name:

Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate

Details on test material:

IUPAC name: Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate
commen name: Tinopal cbs-X
Molecular formula :C28H22O6S2.2Na
Molecular weight :562.572 g/mol
Substance type: organic
physical state: yellow powder
InChIKey :SQAKQVFOMMLRPR-UHFFFAOYSA-N
Smiles :S(c1c(\C=C/c2ccc(c3ccc(\C=C/c4c(cccc4)S(O)(=O)=O)cc3)cc2)cccc1)(=O)(=O)O

Specific details on test material used for the study:

IUPAC name: Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate
commen name: Tinopal cbs-X
Name of test material (as cited in study report): Fluorescent Brightener FWA-5
Molecular formula :C28H22O6S2.2Na
Molecular weight :562.572 g/mol
Substance type: organic
physical state: yellow powder
InChIKey :SQAKQVFOMMLRPR-UHFFFAOYSA-N
Smiles :S(c1c(\C=C/c2ccc(c3ccc(\C=C/c4c(cccc4)S(O)(=O)=O)cc3)cc2)cccc1)(=O)(=O)O
Purity:>98.5%
impurity:Approx 2%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
New zealand white male rabbits were used.
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.2 to 2.3 kg.
- Fasting period before study: no data
- Housing: individually in metal cages
- Diet (e.g. ad libitum): standard pelleted rabbit food ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%):30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Amount / concentration applied:

Amount- 0.5ml
Concentration – 21.3%

Duration of treatment / exposure:

4 hrs

Observation period:

1, 24, 48 and 72 hours

Number of animals:

total=3

Details on study design:

- Area of exposure: 6 sq. cm
- % coverage: no data
- Type of wrap if used: Gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hrs

SCORING SYSTEM: respective mean values for each type of lesion

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

8

Reversibility:

fully reversible within: 24 hrs

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

At one hour, erythema was observed in each animal (one with grade 2; two with grade 1) as was grade 1 edema. At 24-hours, no signs of erythema or edema were observed and the calculated primary irritation index was 0.00 (max.8.0).

Other effects:

At one hour, erythema was observed in each animal (one with grade 2; two with grade 1) as was grade 1 edema.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

(Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate) when applied on the skin of New Zealand White rabbits in concentration 0.5ml of 21.3% in water . No corrosive effects were noted on the treated skin of any animal at observation time. (Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate) is considered to be not irritating to rabbit skin.

Executive summary:

(Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate) was used as a test material to evaluate its skin sensitization potential.

The test was performed on 3 young adult male New Zealand White rabbits weighing 2.2 to 2.3 kg. They were housed individually in metal cages, were kept at a constant room temperature of 20±3 °C, at a relative humidity of 30-70%, and on a 12 hours light cycle day. The animals received ad libitum standard pelleted rabbit food (Nafag No. 814; Gossau, Switzerland) and water. Prior to treatment they were acclimatized for a minimum of 5 days. The test article was applied as a liquid formulation containing 21.3% FWA-5 in water.

 

About 24-hours before treatment an area of about 6 sq. cm was shaved on both flanks of each rabbit. Gauze patch of 2.5 x 2.5 cm covered with 0.5 mL of the test material was applied to one flank and a control patch to the contralateral flank. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The duration of treatment was four hours. The scoring of skin reaction was performed 1, 24, 48 and 72 hours after removal of the dressing. These scores were used in calculating the respective mean values for each type of lesion.

 

At one hour, erythema was observed in each animal (one with grade 2; two with grade 1) as was grade 1 edema. At 24-hours, no signs of erythema or edema were observed and the calculated primary irritation index was 0.00 (max.8.0). The substance did not cause any staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any observation time.

 

(Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate) when applied on the skin ofNew Zealand White rabbits in concentration 0.5ml of  21.3% in water . No corrosive effects were noted on the treated skin of any animal at observation time.(Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate) is considered to be not irritating to rabbit skin.