Registration Dossier

Diss Factsheets

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

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

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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
Mean
Value:
0.061
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
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.

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