Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3',5,5'-tetramethylbiphenyl-2,2'-diol
EC Number:
607-957-9
Cas Number:
26567-10-2
Molecular formula:
C16 H18 O2
IUPAC Name:
3,3',5,5'-tetramethylbiphenyl-2,2'-diol

Test animals / tissue source

Species:
other: Chicken eyes
Strain:
other: ROSS 308
Details on test animals or tissues and environmental conditions:
Chicken heads were collected after slaughter in a commercial abattoir from young chickens (approximately 6-7 weeks old) which are used for human
consumption. Heads were collected by a slaughter house technician and transported at ambient temperature at the earliest convenience.
After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with physiological saline solution, then placed in a lockable plastic box (4-5 heads per box). The heads were received and processed within approximately 2 hours after collection.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 3 positive control treated eyes and 1 negative control eye were examined during the study.
Amount / concentration applied:
- Test item: 30 mg applied onto the entire surface of the cornea
- Positive control: 30 mg powdered Imidazole
- Negative control: 30 µL of physiological saline
Duration of treatment / exposure:
Single exposure of 10 seconds
Observation period (in vivo):
30, 75, 120, 180 and 240 minutes after the post-treatment rinse
Number of animals or in vitro replicates:
3 test item treated eyes
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with 20 mL physiological saline solution at ambient temperature
- Time after start of exposure: 10 seconds from the end of the application

OBSERVATION AND ASSESSMENT OF CORNEAL EFFECTS
Corneal thickness and corneal opacity were measured at all time points. Fluorescein retention was measured on two occasions, at baseline (t=0) and approximately 30 minutes after the post-treatment rinse. Haag-Streit Bern 900 slit-lamp microscope was used for the measurements.

Results and discussion

In vitro

Results
Remarks on result:
not determinable because of methodological limitations
Other effects / acceptance of results:
Although the treatment with test item did not cause any effect, the cornea surfaces were not cleared 180 or 240 minutes after the post-treatment rinse. This fact might indicate morphological changes in an in vivo system (although during in vivo conditions the eyelids will probably clear the surface, but abrasion may occur). Thus, based on this in vitro eye irritation test the test item can not classified as a severe irritant and not classified as non-irritant. However, for precautionary reasons the test item is classified as an eye irritant.

Any other information on results incl. tables

Test item:

Observation

Value

ICE Class*

Mean maximum corneal swelling at up to 75 min

0.0%

I

Mean maximum corneal swelling at up to 240 min

0.0%

I

Mean maximum corneal opacity

0.17

I

Mean fluorescein retention

0.33

I

Other Observations

Remained test item on the surface of the cornea was detected until the 240-min observation point
(1 out of 3) or until the 180-min observation point (2 out of 3)

Overall ICE Class*

3xI

Negative control:

Observation

Value

ICE Class*

Mean maximum corneal swelling at up to 75 min

0.0%

I

Mean maximum corneal swelling at up to 240 min

0.0%

I

Mean maximum corneal opacity

0.00

I

Mean fluorescein retention

0.00

I

Other Observations

None

Overall ICE Class*

3xI

Positive control:

Observation

Value

ICE Class*

Mean maximum corneal swelling at up to 75 min

3.3%

I

Mean maximum corneal swelling at up to 240 min

8.0%

II

Mean maximum corneal opacity

3.67

IV

Mean fluorescein retention

3.00

IV

Other Observations

Remained positive control substance on the surface of the cornea was detected until the 240-min observation point
(3 out of 3)

Overall ICE Class*

1xII 2xIV

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on this in vitro eye irritation test in isolated chicken eyes classification is not possible. However, for precautionary reasons the test item is classified to be irritating to the eye.