1,3-Benzenedisulfonic acid, 4-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-6-[[4-[[3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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 from secondary source

Data source

Reference

Reference Type:

secondary source

Title:

Irritation and sensitization study for CAS no: 2429-73-4

Author:

NTRL

Year:

1982

Bibliographic source:

NTRL, OTS0215029, 1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Skin sensitization study of trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate was performed on human by patch test method

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

No data available

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxynaphthalene-2,7-disulphonate

EC Number:

219-384-8

EC Name:

Trisodium 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxynaphthalene-2,7-disulphonate

Cas Number:

2429-73-4

Molecular formula:

C32H24N6O11S3.3Na

IUPAC Name:

trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate

Details on test material:

- Name of test material (as cited in study report): trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Molecular formula : C32H21N6Na3O11S3
- Molecular weight : 830.717g/mole
- Substance type: organic

Specific details on test material used for the study:

- Name of test material (as cited in study report): trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Molecular formula : C32H21N6Na3O11S3
- Molecular weight : 830.717g/mole
- Substance type: organic

In vivo test system

Test animals

Species:

other: Human

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

No data available

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

not specified

Day(s)/duration:

7 days

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

not specified

Day(s)/duration:

7 days

No. of animals per dose:

200 subjects

Details on study design:

Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:1
- Exposure period:1week
- Test groups:200
- Control group: No data available
- Site: back of the subjects
- Frequency of applications: No data available
- Duration:1 week
- Concentrations: No data available

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: after 7 days
- Exposure period:1week
- Test groups:200
- Control group: No data available
- Site: back of the subject
- Concentrations: No data available
- Evaluation (hr after challenge):After 1 week

Challenge controls:

No data available

Positive control substance(s):

not specified

Study design: in vivo (LLNA)

Statistics:

No data available

Results and discussion

Positive control results:

No data available

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

168

Group:

test chemical

No. with + reactions:

0

Total no. in group:

200

Clinical observations:

No skin sensitization effects was observed

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

Faint Yellow stain on skin after one and two weeks was observed in six subjects .No indication of skin sensitization was observed

Applicant's summary and conclusion

Interpretation of results:

other: Not Sensitizing

Conclusions:

The skin sensitization study of trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate (2429-73-4) was performed by patch test method was considered to be not skin sensitizing in human.

Executive summary:

The skin sensitization study of trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate (2429-73-4)was performed by patch test methodin200 subjects. In induction phase, the sixteen dyed paper were applied to the skin of the back of all subjects under occlusive dressing for one week. In challenge phase, after 7 days on the same site occlusive dressing applied for 1 week. Evaluation was made at the end of the first and second week’s exposure. Faint Yellow stain on skin after one and two weeks was observed in six subjects .No indication of skin sensitization was observed. Hence it is considered that trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate (2429-73-4)was not skin sensitizing in human.