Hexaphenoxycyclotriphosphazene

Endpoint summary

Description of key information

Based on the results of the acute oral toxicity study in Sprague-Dawley rats, GHS classification of the test substance, Phenocycycloposphazene, was classified to be Category 5 or unclassifed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

Adopted: 17th December 2001

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

Test type:

acute toxic class method

Specific details on test material used for the study:

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

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Species: Rat, NTac:SD, SPF
Supplier: Samtako Bio Korea
Sex, age, number and bw(at receipt): Females, 7 weeks old, 13 rats
Sex, age, number and bw(on administration): Female, 8-9 weeks old, 12 rats

Route of administration:

oral: feed

Vehicle:

corn oil

Details on oral exposure:

Individual doses were calculated based on the animal's body weight recorded just prior to dosing at a dose volume of 10 mL/kg body weight. Animals were dosed via gastic intubation with 3 mL disposable syringes fitted with intubation tubes. Animals were fasted overnight, approximately 16 hours prior to dosing. Drinking water was provided ad libitum. Feed was provided approximately 4 hours post dosing.

Doses:

300 mg/kg bw and 2000 mg/kg bw

No. of animals per sex per dose:

3

Statistics:

Statistical analysis was not performed. Mean scores and values are presented.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the duration of the study at 300 and 2000 mg/kg body weight (bw) dose levels. There were no effects on mortality.

Clinical signs:

other: During the observation period, no clinical abnormalities were observed in any animals at 300 and 2000 mg/kg bw.

Other findings:

Necropsy Findings
No grossly visible evidence of morphologic abnormalities was evident in any animals at 300 and 2000 mg/kg bw.

Since no gross findings were observed at necropsy, histopathological examinations were not performed.

Interpretation of results:

other: Category 5 or unclassifed

Conclusions:

Based on the results of the acute oral toxicity study in Sprague-Dawley rats, GHS classification of the test substance, Phenocycycloposphazene, was classified to be Category 5 or unclassifed.

Executive summary:

The purpose of this study was to assess the potential toxicity and to classfy category in GHS classification of the test substance, Phenoxycycloposphazene, following a single oral administration to female Sprague-Dawley rats.

Four steps of three female rats per step were utilized as follows:

Step 1 and 2: 300 mg/kg body weight (bw) of the test substance

Step 3 and 4: 2000 mg/kg bw of the test substance

Step 1: 300 mg/kg bw was administrated. Then, there were no mortalities (Step 1). Asecond dose of 300 mg/kg bw was administrated (Step 2).

Step 3: There were no mortalities (Step 1 and 2). A third dose of 2000 mg/kg bw was administrated. Then, there were no mortalities (Step 3). A fourth dose of 2000 mg/kg bw administratered (Step 4).

All animals were monitored for clincal signs and body weight changes during the 14 days observation period after administration. They were subjected to gross necropsy at the end of the observation period.

There were no deaths in any animals at 300 and 2000 mg/kg bw. No test substance-related effects were evident in clinical signs, body weight data and necropsy findings in any anmimals at 300 and 2000 mg/kg bw.

Based on the results of the acute oral toxicity study in Sprague-Dawley rats, GHS classification of the test substance, Phenocycycloposphazene, was classified to be Category 5 or unclassifed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

other: Annex V

GLP compliance:

yes

Limit test:

yes

Species:

other: rat(wistar)

Type of coverage:

semiocclusive

Vehicle:

other: Olive oil

Duration of exposure:

24h

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No signs of systemic toxicity observed.

Gross pathology:

Effects on organs:
There were no macroscopic abnormalities observed at time of
autopsy.

Other findings:

Signs of toxicity (local):
No clinical signs were evident in any animal over the
test/observation period.
Erythema were present in all animals on days 2 through 4.
One animal (female) exhibited Erythema on days 2 through 6
and crusts on days 4 through 12.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Justification for classification or non-classification

In the acute toxicity study, there were no deaths in any animals at 300 and 2000 mg/kg bw. No test substance-related effects were evident in clinical signs, body weight data and necropsy findings in any anmimals at 300 and 2000 mg/kg bw. Therefore, it was classified to be Category 5 or unclassifed.