Registration Dossier

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:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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