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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 January 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to guideline
Guideline:
other: Skin sensitisation/patch test test
Principles of method if other than guideline:
None
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]
EC Number:
276-882-8
EC Name:
Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]
Cas Number:
72828-69-4
Molecular formula:
C47H42N10O12S4.2Na
IUPAC Name:
disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
None

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 200
Clinical history:
1. General well being
2. Absence of any skin diseases which might be confused with skin reactions from the test material'
3. Willingness to cooperate
4. Dependability and intelligence in following directions
5. Reading, understanding and signing an informed consent contract.
Controls:
None
Route of administration:
dermal
Details on study design:
None

Results and discussion

Results of examinations:
Visible skin changes signifying reaction to injury were observed in 1 out 200 human subjects during the series of application or following the challenge application. On re-challenge, the component found to be responsible was Irganol Yellow 4Glass 125 % (FAT 21015).

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
FAT 21015 is considered to be neither a primary irritant nor a sensitizer.
Executive summary:

A key study was performed in humans to determine skin irritation potential of FAT 21015. Visible skin changes signifying reaction to injury were observed in 1 out of 200 subjects during the series of application or following the challenge application. In re-challenge, the component found to be responsible was FAT 21015. Despite the reactions elicited by the component and/or the components contained therein, it is the opinion of the investigator that the results must be interpreted as indicative of having potential rather than obligatory irritating capabilities because of unusual conditions of the test.