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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliable review of similar substances. Further animal testing cannot be justified
Justification for type of information:
Assessment based on structural activity and grouping with similar substances

Data source

Reference Type:
other company data
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Sulphonated azo dyes
Sulphonated azo dyes

Test animals


Test system

Type of coverage:
not specified
Preparation of test site:
not specified
not specified

Results and discussion

In vivo

Irritation parameter:
other: Assessment
Time point:
24/48/72 h
Max. score:
Remarks on result:
other: Not considered to be irritating to skin

Any other information on results incl. tables

Considered non-irritating based on review of animal testing on this group of substances.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: EU
Under the study conditions of similar structures, for the test substance the skin irritation is considered non-irritating.
No further animal testing can be justified.
Executive summary:

As with all dyes, the intense colour can mask effects on the skin and good studies will have included local histology assessment of skin to see if microscopic damage at cellular level. This was not apparent in the data reviewed, but there is no indication of adverse effects from in-vivo skin irritation studies.


Most studies reviewed appeared to follow the principles of OECD 404, with some 3-rabbit EU studies and 6-rabbit US studies. Scoring methods reported were typically based on Draize, but some reported individual scores, some reported mean scores and some reported totals; this made interpretation difficult as methods were not always clear. However, conclusions are consistently negative.


No references have been found with regard to in-vitro assessments.


Historical use has not indicated any local irritation to skin to workers or users and there is a high level of confidence that there is no local skin irritation. However, in view of potential sensitising effects, care is needed to avoid repeated skin exposure to concentrated material. 


Data reviewed has been predominantly based on rabbit testing, but data on rat (acute dermal toxicity) and guinea pigs (non-maximised methods as well as challenge phases of maximised studies) shows a good level of local tolerance


No further animal testing can be justified.