Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)

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 is from NTRL reports

Data source

Reference

Reference Type:

secondary source

Title:

Contact Sensitization potential of Diazine Black H conc 125%

Author:

NTRL report

Year:

1983

Bibliographic source:

OTS0215154, NTRL report, last updated 1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Modified Draize- Shelanski Repeat Insult Patch Test

Principles of method if other than guideline:

Modified Draize- Shelanski Repeat Insult Patch Test was performed on human volunteers to ascertain the degree of sensitization caused by Chlorazol Black BH[CAS:2429-73-4].

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

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

Test material form:

solid

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
- Common Name: Chlorazol Black BH
- Molecular formula : C32H21N6Na3O11S3
- Molecular weight : 830.717g/mole
- Substance type: organic
- Physical State: Solid

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
- Common Name: Chlorazol Black BH
- Molecular formula : C32H21N6Na3O11S3
- Molecular weight : 830.717g/mole
- Substance type: organic
- Physical State: Solid

In vivo test system

Test animals

Species:

other: humans

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

no data available

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

not specified

Concentration / amount:

no data available

Day(s)/duration:

ten alternate-day 24-hour period

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

not specified

Concentration / amount:

no data available

Day(s)/duration:

24 hours

Adequacy of challenge:

not specified

No. of animals per dose:

208 male volunteers

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: ten alternate-day 24-hour period
- Exposure period: 24 hour period
- Test groups: 208
- Control group: number not mentioned
- Site: backs
- Frequency of applications: 10 alternate day applications
- Duration: 24 hours
- Concentrations: undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: one day
- Exposure period: 24 hours
- Test groups: 208
- Control group: no data available
- Site: backs
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 hours after removal of the challenge patches

Challenge controls:

no data available

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

No. with + reactions:

0

Total no. in group:

208

Clinical observations:

No instances of contact sensitization were observed in any of the volunteers.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

No instances of contact sensitization were observed in any of the volunteers.
Hence, Chlorazol Black BH[CAS:2429-73-4] can be considered to be not sensitizing to skin.

Executive summary:

Modified Draize- Shelanski Repeat Insult Patch Test was performed on human volunteers to ascertain the degree of sensitization caused by Chlorazol Black BH [CAS:2429-73-4].

Undiluted Chlorazol Black BH [CAS:2429-73-4] was applied to the patch sites on the backs of 208 male volunteersfor ten alternate-day 24-hour period under occlusion. Following a seven day rest period, challenge patches of Chlorazol Black BH [CAS:2429-73-4] were applied to the fresh sites on the backs of 208 male volunteers similar to the induction phase for 24 hours. The challenge sites were evaluated 24 hours after removal of the challenge patches.

No instances of contact sensitization were observed in any of the volunteers.

Hence,Chlorazol Black BH [CAS:2429-73-4] can be considered to be not sensitizing to skin.