Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Amount / concentration applied:
0.5 mL/site
Duration of treatment / exposure:
4 hrs
Observation period:
1, 24, 48, 72 hrs after application, observation was continued for 14 days after the last patch was removed.
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
Max. score:
0
Reversibility:
not specified
Irritation parameter:
other: eschar
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Other effects:
No treatment-related clinical signs, body weight changes, dead animals, or abnormal skin reaction were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met