Hexaphenoxycyclotriphosphazene

Eye irritation

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye 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:

25 June 2018

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

482-200-1

EC Name:

-

Cas Number:

1184-10-7

Molecular formula:

C36H30N3O6P3

IUPAC Name:

hexaphenoxy-1,3,5,2λ⁵,4λ⁵,6λ⁵-triazatriphosphinine

Test material form:

solid

Specific details on test material used for the study:

Batch/Lot number: 190202
Description: White or light yellow crystal
Purity: 99.53%
Expiry date: 31 January 2021
Storage conditions: Controlled room temperature (15-25o
C, ≤70% relative
humidity)
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses,
face mask) for unknown materials were applied to assure
personnel health and safety.

Test animals / tissue source

Species:

chicken

Strain:

other: ROSS 308

Details on test animals or tissues and environmental conditions:

Chicken heads were collected after slaughter in a commercial abattoir from chickens (approximately 7 weeks old) which are used for human consumption. Heads were collected by a slaughter house technician and heads transported to Citoxlab Hungary
Ltd. at ambient temperature at the earliest convenience. After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with saline, then placed in a plastic box which was closed (4-5 heads per box). The heads were received at Citoxlab Hungary Ltd. and processed
within 2 hours of collection in each experiment.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

30 mg of the powdered test item

Duration of treatment / exposure:

In each experiment, 30 mg of the powdered test item was applied onto the entire surface of the cornea attempting to cover the cornea surface uniformly with the test item, taking care not to damage or touch the cornea. In each experiment, negative control eye was treated with 30 µL of physiological saline; positive control eyes were treated with 30 mg powdered Imidazole. One eye was treated with physiological saline, three eyes with the powdered test item and another three with powdered Imidazole in each experiment.

Duration of post- treatment incubation (in vitro):

The time of application was noted, then after an exposure period of 10 seconds from the end of the application the cornea surface was rinsed thoroughly with 20 mL physiological saline solution at ambient temperature, taking care not to damage the cornea but attempting to remove all residual test material if possible. Additional gentle rinsing (one or three times with 20 mL saline) was performed at each time point of both experiments when the test item or positive control material remaining on the cornea was observed.

Number of animals or in vitro replicates:

Experiment I and Experiment II

Details on study design:

In the first experiment, the test item was stuck on all cornea surfaces after the posttreatment rinse. One cornea surface (1/3) was cleared at 30 minutes, one cornea surface (1/3) at 75 minutes and the third cornea surface (1/3) was cleared at 120 minutes after the post-treatment rinse. In the second experiment, the test item was stuck on two cornea surfaces (2/3) after the post-treatment rinse. One cornea surface (1/3) was cleared at 30 minutes, the other cornea surface (1/3) was cleared at 120 minutes after the post-treatment rinse. In each experiment, positive control material was stuck on all cornea surfaces after the post-treatment rinse, the cornea surfaces (3/3) were not cleared at 240 minutes after the post-treatment rinse.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

percent corneal swelling

Run / experiment:

Experiment I

Value:

ca. 0

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Run / experiment:

Experiment I

Value:

ca. 0.17

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

fluorescein retention score

Run / experiment:

Experiment I

Value:

ca. 0.17

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

percent corneal swelling

Run / experiment:

Experiment II

Value:

ca. 0

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

cornea opacity score

Run / experiment:

Experiment II

Value:

ca. 0

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

fluorescein retention score

Run / experiment:

Experiment II

Value:

ca. 0.17

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

The results from all eyes used met the quality control standards. The negative control and positive control results were within the historical data range in each experiment. This study was considered to be valid.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on these in vitro eye irritation assays in isolated chicken eyes withHPC TP, the test item was non-irritant, UN GHS Classification: No Category.

Executive summary:

An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No. 438 guideline (25 June 2018). In each experiment after the zero reference measurements, the eye was held in horizontal position and 30 mg powdered test item was applied onto the centre of the cornea in such a way that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with physiological saline. Positive control eyes were treated with 30 mg powdered Imidazole. The negative control eye was treated with 30 µL of physiological saline (0.9% (w/v) NaCl solution). In each experiment, three test item treated eyes, three positive control treated eyes and one negative control treated eye were examined. The results from all eyes used in the study met the quality control standards. The negative control and positive control results were within the historical control data range in each experiment. Thus, the study was considered to be valid. Experiment I: No corneal swelling was observed during the four-hour observation period on test item treated eyes. Minimal cornea opacity change and fluorescein retention change was observed on all three eyes. Test item was stuck on all cornea surfaces after the post-treatment rinse. One cornea surface (1/3) was cleared at 30 minutes, one cornea surface (1/3) at 75 minutes and the third cornea surface (1/3) was cleared at 120 minutes after the post-treatment rinse. Experiment II: No corneal swelling was observed during the four-hour observation period on test item treated eyes. No cornea opacity change was observed on all three eyes. Minimal fluorescein retention change was noted on all three eyes. Test item was stuck on two cornea surfaces (2/3) after the post-treatment rinse. One cornea surface (1/3) was cleared at 30 minutes, the other cornea surface (2/3) was cleared at 120 minutes after the post-treatment rinse. Based on these in vitro eye irritation assays in isolated chicken eyes with HPCTP, the test item was non-irritant, UN GHS Classification: No Category.