Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Nov 01 - Dec 11, 2018
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
2017
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Version / remarks:
Commission Regulation (EU) 2017/735 of 14 February 2017 amending, for the purpose of its adaption to technical progress, the Annex to Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2’-Phenyl-biphenyl-2-yl-(9,9-dimethyl-9H-fluoren-2-yl)-(9,9’-spirobifluoren-2-yl)-amine
EC Number:
949-957-4
Molecular formula:
C58H41N
IUPAC Name:
2’-Phenyl-biphenyl-2-yl-(9,9-dimethyl-9H-fluoren-2-yl)-(9,9’-spirobifluoren-2-yl)-amine
Test material form:
solid
Specific details on test material used for the study:
PREPARATION OF THE TEST MATERIAL
The test item was prepared as a 20% (w/v) solution in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation.

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL: 750 µL (i.e. 150mg/750µL)

NEGATIVE / VEHICLE CONTROL: 750 µL

Designation: 0.9% sodium chloride solution
Supplier: B. Braun Melsungen AG, Germany
Batch: 17361013
Storage: 2 to 8°C
Released until: August 2020


POSITIVE CONTROL: 750 µL

Designation: Art. 814223
Synonym: Imidazole
Supplier: Merck KGaA, Germany
Batch: S5798623
Purity (GC) 99.8% (a/a)
Storage: At room temperature
Released until: April 30, 2023

Imidazole was dissolved with 0.9% sodium chloride solution to a concentration of 20% (w/v).

Duration of treatment / exposure:
240 minutes
Number of animals or in vitro replicates:
in vitro: triplicate design

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Run 1 / Experiment 1
Value:
5.8
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not determinable
Remarks:
According to OECD 437 no prediction can be made regarding the eye hazard potential of the test item.
Other effects / acceptance of results:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 0.1 and, thus, within three standard deviations of the current historical mean of the negative control (IVIS: -1.4 – 3.1).
- Acceptance criteria met for positive control: After treatment with the positive control (20% Imidazole) the calculated IVIS was 117.0 and, thus, also within two standard deviations of the current historical mean of the positive control (IVIS: 82.3 – 132.4).

Therefore, the study fulfilled the acceptance criteria.

Any other information on results incl. tables

Results

The IVIS obtained after treatment with the test material was 5.8 and, thus higher than 3 and lower than 55, i.e. according to OECD 437 no prediction can be made regarding the eye hazard potential of the test item.

The results are given in the following table:

 

Opacity

Permeability

IVIS

per cornea

per group (mean value)

Standard deviation

Negative
control

0.9% sodium chloride solution

0.0

-0.001

-0.015

0.1

0.4

0.6

-0.003

0.555

-0.1

-0.002

-0.130

Positive
control

Imidazole
(20%)

68.44

1.928

97.320

117.0

17.1

86.2

2.630

125.650

70.4

3.846

128.090

Test item

Test material preparation

4.6

-0.001

4.585

5.8

4.4

2.1

-0.002

2.070

10.7

-0.001

10.685


No observations (e.g. tissue peeling, residual test chemical, non-uniform opacity patterns) were seen in a visually inspection of the corneas after treatment.

Study Acceptance Criteria


After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 0.1 and, thus, within three standard deviations of the current historical mean of the negative control (IVIS: -1.4 – 3.1). After treatment with the positive control (20% Imidazole) the calculated IVIS was 117.0 and, thus, also within two standard deviations of the current historical mean of the positive control (IVIS: 82.3 – 132.4). Therefore, the study fulfilled the acceptance criteria.
The resulting classification of the test item in this study is unequivocal and no borderline results were obtained. Therefore, a single testing run composed of three corneas per group was considered sufficient.


Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the conditions of the present study, the eye hazard potential of the test item cannot be predicted.
Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. Under the conditions of the present study, the eye hazard potential of the test item cannot be predicted.