Hexaphenoxycyclotriphosphazene

Endpoint summary

Description of key information

HPCTP is not classified to Skin irritation/corrosion and Eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Adopted: 28, July, 2015

Qualifier:

according to guideline

Guideline:

other: Testing Guidelines for Studies of Chemicals

Version / remarks:

Notification No. 2018-12, issued by the National Institute of Environmental Research, Republic of Korea on 9, April, 2018

GLP compliance:

yes

Specific details on test material used for the study:

Lot No. 180705
Purity: 99.08%
Appearance: White crystal
Storage condition: Room temperature

Species:

rabbit

Details on test animals or test system and environmental conditions:

Species: New-Zealand white-Rabbit
Sex, number and body weight range (on administration): Males, 3 rabbits, 2.334-2.574 kg
Temperature: 17.0-23.2 oC(average: 19.5 oC)
Relative humidity: 30.0-70.0%(average:44.5%)
Air changes: 10-15 times/hour
Lighting: 12 hour light/dark cycle
Intensity of illumination: 150-300 Lux

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3

Details on study design:

Initial test were performed with one animal. The test item was applied to the animal three times in sequence. When ovserving the first three minutes and one hour after the applicaiton was do not observed skin irritation. Applied to the other parts of the third for 4 hours the skin reactions were evaluated scores. Since corrosive effect was not observed in the initial test, two additional animals were used for the confirmatory test. Skin reactions of each animal were evaluated applying 4 hours. Also the set control region does not apply the test item in the same animal.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

HPCTP does not belong to the category planned in this study. Therefore test item was determined to "Not classified".

Executive summary:

This study was conducted to evaluate the dermial irritant and/or corrosive response of the test item, Phenoxycycloposphazene. A total of 3 rabbits was treated with test item, and the skin reaction was observed for a maximunm of 3 day.

The test results are shown below.

1) Deaths and abnormal symptoms by test item were not observed.

2) Change of body weight by test item was not observed.

3) In the initial test, corrosive response was not observed.

4) In the initial and confirmatory test, the mean score of the three animals was 0.0, and the mean score of the two high-score animals among the three animals was 0.0.

5) Skin irritation by the test item lasted for up to 3 days.

6) Other reaction by the test item was not observed.

According to the above results, test item, Phenoxycycloposphazene does not belong to the category planned in this study. Therefore test item was determined to "Not classified".

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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)

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.

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.

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.

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

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

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results of Skin irritation and Eye irritation studies, no adverse effect was observed.