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Toxicological information

Skin sensitisation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 group
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.