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Diss Factsheets

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test was performed on humans not following the official guidelines, some details on test conditions are missing. The study is acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Human repeated insult patch test
Deviations:
not specified
Principles of method if other than guideline:
Valid human data
GLP compliance:
no
Type of study:
other: evaluation of dermal effects
Justification for non-LLNA method:
no data

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]
EC Number:
220-027-3
EC Name:
Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]
Cas Number:
2610-10-8
Molecular formula:
C45H32N10O21S6.6Na
IUPAC Name:
hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulpho
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
Two hundred individuals were employed to participate in this evaluation. Prior to inclusion in the study panel, all of-the candidates were briefed as to the purpo se of the study, the procedure to which they would be subjected, and the hazards which might be anticipated as a consequence thereof. Parents of minor participating in this study were briefed along with their children so that parentalconsent could be obtained.Informed-consent forms were obtained from all individuals, the parents signing on behalf of the participating minors. The ages of the participants selected ranged from 2 to 65 years. Approximately 1/3 were males and 2/3 were females.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
4% of aqueous solutions
Challenge
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
4% of aqueous solutions

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: mean of readings
Group:
test chemical
Dose level:
4% solution
No. with + reactions:
0
Total no. in group:
200
Clinical observations:
human insult patch test
Remarks on result:
other: not determined
Reading:
other: mean of readings
Group:
negative control
No. with + reactions:
0
Remarks on result:
no indication of skin sensitisation
Reading:
other: mean of readings
Group:
positive control
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

In all of the applications, no visible skin changes signifying reaction to injury were observed in any of the 200 subjects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No participants showed an adverse effect about sensitizing. Insofar as sensitization is concerned, the extrapolation of these results to a general population is limited statistically by the number of test subjects. In this case since 200 subjects were used, we may predict with 95% certainty that at least 98.34% of a general population will not be sensitized by this material.
Executive summary:

All of the tested group, under the test conditions, were not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant, fatiguing agent or sensitizer in any of the 200 subjects.