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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-norcoco alkyl derivs.
EC Number:
263-170-7
EC Name:
1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-norcoco alkyl derivs.
Cas Number:
61791-38-6
Molecular formula:
an exact molecular formula cannot be provided for an UVBC, most representative example: C16H32N2O
IUPAC Name:
2-(2-heptadecyl-4,5-dihydro-1H-imidazol-1-yl)ethan-1-ol; 2-(2-pentadecyl-4,5-dihydro-1H-imidazol-1-yl)ethan-1-ol; 2-(2-tridecyl-4,5-dihydro-1H-imidazol-1-yl)ethan-1-ol; 2-(2-undecyl-4,5-dihydro-1H-imidazol-1-yl)ethan-1-ol
Test material form:
liquid

In vitro test system

Test system:
artificial membrane barrier model
Source species:
other: n/a
Cell type:
other: n/a
Cell source:
other: artificial membrane barrier model
Source strain:
other: n/a
Vehicle:
unchanged (no vehicle)
Amount/concentration applied:
500 μl
Number of replicates:
5

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
A positive control (1.0 N sodium hydroxide) and a negative control (1% citric acid) were tested concurrently.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: Mean Breakthrough Time (minutes)
Value:
167.89
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Packing Group: Packing Group III
GHS Sub-category: 1C
Corrosivity: Mild
Executive summary:

The test article was analyzed using the Corrositex® test method to determine their dermal corrosivity potential and Packing Group designations. The 1.0 N sodium hydroxide positive control had a breakthrough time of 14.35 minutes, which fell within the range allowed (>13.7 and <22.2 minutes). The 1% citric acid negative control had a breakthrough time of >65.00 minutes, which met the acceptance criterion of >60 minutes.

The results of this study indicated that 1H-Imidazole-1-Ethanol, 4,5-Dihydro-2-Norcoco Alkyl Derivs. batch# FPAC1717924 was compatible with the Corrositex® system. The mean times required to penetrate

the synthetic biobarriers and the Packing Group classifications of these test articles are listed below.

Packing Group:              Packing Group III       

GHS Sub-category:       1C       

Corrosivity:                    Mild