Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 minute exposure
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guideline study 2018 to GLP.
All quality crieteria met

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Commercial grade containing approximately 45% actives
Specific details on test material used for the study:
PAH 330/132/1A
The sample had been partly concentrated up to ca 50% (repored 49.38) to prepare as concentrated form of the material as possible for testing.
Attempts to concentrate further appeared to impact on stability.

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent vehicle
Amount/concentration applied:
The test item was applied topically to the corresponding tissues ensuring uniform covering.
10 µL (26.3 µL/cm2) of the test item was applied to the epidermis surface
Duration of treatment / exposure:
15 minutes
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Average
Value:
ca. 66.6
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
No other effects reported
The solution containing the test item was a yellow color. This color was attributed to the intrinsic color of the test item itself. It was therefore unnecessary to run color correction tissues

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Considered non-classified
Executive summary:

The relative mean viability of the test item treated tissues was66.6% after the 15‑Minute exposure period and 42‑Hours post‑exposure incubation period.