Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, guideline study, available as unpublished report, restrictions in reporting (available report is a summary) but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: 1,2,3,4-Tetrahydroisoquinoline
- pH (undiluted): ca. 8
- Test substance number: 05/0797-1
- Batch number: LJ 32741/75

Test animals

Species:
other: Human skin model EpiDermâ„¢

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
3 min and 1 h
Number of animals:
2 tissue replicates per treatment

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
47
Remarks on result:
other:
Remarks:
Time point: 3 minutes. Max. score: 100.0. (migrated information)
Irritation / corrosion parameter:
other:
Value:
14
Remarks on result:
other:
Remarks:
Time point: 1 hour. Max. score: 100.0. (migrated information)

In vivo

Irritant / corrosive response data:
Viability results (% relative to negative control):
- test material: 47% and 14% upon exposure for 3 minutes and 1 hour, respectively.
- positive control: 20% and 9% upon exposure for 3 minutes and 1 hour, respectively.

Evaluation: corrosive
The test method does not yet allow for the dffferentlation of severity of the effect The results however indicate moderate corrosivity (EC: R 34, GHS: subcategory 1B). For final assignment of a risk phrase at present, further evidence or results from an in vlvo study would be needed.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information