Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: recent test according to validated method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ECVAM (Final draft performance standards ATLA 35, 559-619, 2007
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Human epidermis model

Test animals

Species:
human

Test system

Type of coverage:
open
Preparation of test site:
other: human epidermis model
Vehicle:
unchanged (no vehicle)
Controls:
yes
Duration of treatment / exposure:
15min
Observation period:
42h
Number of animals:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: viability percentage
Value:
100
Remarks on result:
other:
Remarks:
Basis: mean 100. Remarks: no mortality. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS