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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Direct Blue 267
IUPAC Name:
Direct Blue 267

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: distilled water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0.3
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0.3
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritant / corrosive response data:
Changes fully reversible within 2 days
Other effects:
Blue staining of application site

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information under Regulation 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for skin irritation following EU Method B4. Under the experimental conditions the substance does not show any skin irritation potential
Executive summary:

The substance was tested for skin irritation following EU Method B4. Three NZW Rabbits were exposed with a semi-occlusive patch to the tested substance for 4h. Erythema and edema score were registered. Under the experimental conditions the substance does not show any skin irritation potential