Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: data obtained after Article 25(3) request
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Acid Black 173 - Similar Substance 01
IUPAC Name:
Acid Black 173 - Similar Substance 01
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
HC:NZW

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Non skin irritant
Executive summary:

Method

The substance has been tested for its skin irritation potential according to the OECD guideline 404.

Results

Non skin irritant