Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of sodium methyl sulphate and 1-methylpyridinio-3-carboxylate
EC Number:
947-816-1
Cas Number:
00-00-0
Molecular formula:
previous identifier no longer suitable
IUPAC Name:
Reaction mass of sodium methyl sulphate and 1-methylpyridinio-3-carboxylate
Test material form:
liquid

In vitro test system

Test system:
human skin model
Source species:
other: n.a. skin model
Cell type:
other: n.a. skin model
Cell source:
other: n.a. skin model
Source strain:
other: n.a. skin model
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean
Value:
115.4
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test article, Reaction mass of sodium methyl sulphate and 1-methylpyridinio-3-
carboxylate, was considered not to be irritant in the in vitro skin model EpiDerm™
SIT (EPI-200).

Categories Display