Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2015
Reliability:
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
Reference Type:
other company data
Title:
Unnamed
Year:
2016
Report Date:
2106

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

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:
GHS criteria not met
Conclusions:
Under the study conditions of similar structures, for the test substance the skin irritation is considered non-irritating.
No further animal testing canbe justified.
Executive summary:

As withall 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.