4-(5-Propyl-tetrahydropyran-2-yl)-phenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The information for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 437.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-(5-Propyl-tetrahydropyran-2-yl)-phenol

EC Number:

919-949-5

Cas Number:

879544-24-8

Molecular formula:

C14 H20 O2

IUPAC Name:

4-(5-Propyl-tetrahydropyran-2-yl)-phenol

Test material form:

solid: particulate/powder

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

Fresh isolated bovine eyes of cattle were used in this study.
Slaughterhouse: Odenwaldschlachthof Brensbach, 64395 Brensbach, Germany
Age of cattle: 14 - 23 months
Corneal diameter: 25 - 28 mm

Test system

Vehicle:

other: 0.9 % sodium chloride solution

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

750 µL of the suspended test item (i.e. 150 mg/750 µL), positive or negative control were applied on the corneas.

Number of animals or in vitro replicates:

NUMBER OF REPLICATES: 3

NEGATIVE CONTROL USED: 0.9% sodium chloride Solution
POSITIVE CONTROL USED: 20 % imidazole in 0.9 % sodium chloride solution
APPLICATION DOSE: 750 μL
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes, 240 min
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3 times
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity value of each individual cornea was corrected for background opacity by subtracting the initial baseline opacity reading from the post treatment opacity reading. In addition, the opacity values of both the treatment and positive control groups were corrected for the mean negative control opacity values.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The decision criteria as indicated in the OECD TG 437 were used.

IVIS
<3 No Category
>3<55 No prediction can be made
>55 Category 1

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

mean

Value:

65.3

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

OTHER EFFECTS:
- Visible damage on test system: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (IVIS = 1.0)
- Acceptance criteria met for positive control: yes (IVIS = 96.1)

Any other information on results incl. tables

The IVIS obtained after treatment with the test substance was 65.3 and, thus, higher than 55, i.e. according to OECD 437 the test item is inducing serious eye damage (UN GHS: Category 1). 

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

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the conditions of the present study, the test item did show an eye hazard potential. The test item is inducing serious eye damage (UN GHS: Category 1).