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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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 group
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.