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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22/09/2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2022

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
14/06/2020
Deviations:
yes
Remarks:
A typing error deviation which was assessed by the Study Director to not affect the validity and integrity of the scientific results obtained during this study
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide
Cas Number:
129684-50-0
Molecular formula:
C21H43N2O.Br
IUPAC Name:
N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide
Test material form:
liquid: viscous

In vitro test system

Test system:
human skin model
Source species:
other: Artificial 3-dimensional model of human skin
Vehicle:
unchanged (no vehicle)

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
After 3 minutes
Value:
3.6 - 7
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
After 1 hour
Value:
4.9 - 6.5
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Under the present test conditions Dimethylaminopropylmethacrylamide, dodecyl bromide tested at two exposure periods of 3 minutes and 1 hour was cytotoxic and, hence, predicted to be corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.