Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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.