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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study Initiation date: 04 April 18 Study conclusion date: 17 May 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

2017

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

Test animals / tissue source

Species:

human

Details on test animals or tissues and environmental conditions:

TEST ITEM:
EpiOcular™ (OCL-200) Reconstructed Human Ocular Epithelium
Lot # 27036
Keratinocyte Strain 4F1188

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

20 μI of PBS (sterile Dulbecco's Phosphate Buffered Saline) + 50 μI of test item

Duration of treatment / exposure:

30 minutes ± 2 minutes

Duration of post- treatment incubation (in vitro):

2 hours ± 15 minutes

Number of animals or in vitro replicates:

3

Details on study design:

Details of materials, reagents and equipment used are recorded in the study data.
Positive control -Methyl Acetate
Negative control - Sterile Water (tissue grade)

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

Mean

Value:

0.061

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

in vitro irritation score

Remarks:

Mean of viability

Value:

2.838

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Prior to the study, the required preliminary test confirmed that the test item did not interfere with MTT or solvent.

% of viability: 2.838 - Classification = No prediction.

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 60% and therefore “no prediction” regarding the irritation or corrosive potential of the substance can be determined according to OECD 492. OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. 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 492, the registered substance is a Eye Irritant Category 2.

Executive summary:

The eye irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 492. After 30 ± 2 minutes exposure on the surface of the EpiOcular reconstructed ocular epithelium, and a 2 hour ± 15 minutes post-incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.838% and no prediction can be made for Agent 447C (a 40% solution of the registered substance) as further information is required to distinguish between corrosive and irritating.

 

In vitro testing with OECD 492 has not allowed for a prediction of eye irritation of Agent 447C (a 40% solution of the registered substance). As OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the “no prediction” result with OECD 492, the registered substance is a Eye Irritant Category 2.