Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-06-19 to 2003-06-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Non GLP study performed according to a method similar to OECD Guideline 430 and EU Method B.40. Although limited study details are given, the information is sufficient to determine the reliability.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
Principles of method if other than guideline:
The skin corrosivity potential of the test substance was assessed using the Transcutaneous Electrical Resistance Assay (TER). This involved the application of the test substance to the epidermal surface of skin discs, obtained from a humanely-killed young Wistar strain rat.
GLP compliance:
no
Remarks:
The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material: JNJ-1692405-AAC (T002006)
- Appearance: yellow powder
- Physical state: solid
Specific details on test material used for the study:
no data

In vitro test system

Test system:
isolated skin discs
Source species:
rat
Source strain:
Wistar
Details on animal used as source of test system:
TEST ANIMALS: epidermal surface of skin discs, obtained from a humanely killed young Wistar strain rat

ENVIRONMENTAL CONDITIONS: no data
Vehicle:
not specified
Details on test system:
TEST SITE: The integrity of each pelt was confirmed using a Quality Control test. Only acceptable pelts were used to supply skin discs for use in the main study.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, removed using a jet of warm tap water
- Time after start of exposure: after 24 hour exposure


SCORING SYSTEM:
- Corrosive substances produce an irreversible loss of normal stratum corneum integrity and function; this is measured as a reduction in the inherent TER. A threshold value has been established (5 kΩ), below which materials are considered likely to be corrosive in vivo. The TER was measured using a low voltage alternating current electronic databridge.
Control samples:
no
Amount/concentration applied:
TEST MATERIAL: no data

VEHICLE: no data
Duration of treatment / exposure:
24 hours
Number of replicates:
3 skin discs

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
transcutaneous electrical resistance (in kΩ)
Run / experiment:
1
Value:
5.27
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: Basis: mean; time point: 24 hours; standard deviation = 0.3.
Other effects / acceptance of results:
- The mean electrical resistance (kΩ) was 5.27 +/- 0.3. Following visual inspection, each skin disc was found to have a pale (bleached) appearance.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Although the mean electrical resistance was above the cut-off value of 5 kΩ, after visual inspection of the skin discs, the test material was considered to have the potential to be corrosive in-vivo under the conditions of the test.