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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study Initiation date: 18 May 18 Study conclusion date: 24 Sep 18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
2015
GLP compliance:
yes (incl. QA statement)

Test material

1
Chemical structure
Reference substance name:
Octan-1-ol, reaction products with diphosphorus pentaoxide, potassium salts
EC Number:
807-789-8
Cas Number:
111062-42-1
Molecular formula:
C8-H18-O.K.O5-P2
IUPAC Name:
Octan-1-ol, reaction products with diphosphorus pentaoxide, potassium salts
Specific details on test material used for the study:
Test Item name: Agent 447C
Purity: 40% Active in water, ~90% purity of active material

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: All cells used are purchased or derived from tissue obtained by MatTek Corporation from accredited institutions
Justification for test system used:
Recommended test system in international guidelines (OECD)
Vehicle:
unchanged (no vehicle)
Details on test system:
Reconstructed Human Epidermis (RHE) tissue
- MatTek EpiDerm Tissue model EPI-200, Lot # 28614
-Keratinocyte Strain 00267
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- amount applied: 30μI
-
Duration of treatment / exposure:
60 ± 1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% RH)
Duration of post-treatment incubation (if applicable):
42 ± 4 hours post-treatment incubation
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
2.589
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
Other effects:
Colour interference with MTT: no

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The test determined that a 40% solution of the registered substance reduced the viability to below 50% and is therefore an "irritant" according to OECD 439. OECD 439 cannot resolve between UN GHS Categories 1 and 2, further information on skin corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439, the registered substance is a Skin Irritant Category 2.
Executive summary:

The skin irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 439. After 60 ± 1 minute exposure on the surface of the EpiDerm reconstructed human epidermis, and a 42 ± 4-hours post-exposure incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.589% and therefore Agent 447C (a 40% solution of the registered substance) was classified as irritant to the skin.

 

As OECD 439 cannot resolve between UN GHS Categories 1 and 2, further information on skin corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439, the registered substance is a Skin Irritant Category 2.

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