1-Octanol, reaction products with phosphorus oxide (P2O5), potassium salts

Skin irritation / corrosion

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

Test material information

1

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.