E17-194T, (P,P-diethyl, monoester with 1,2 propanediol)_

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 26, 2017 - January 10, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: JMAFF 12-Nousan-8147

Version / remarks:

2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate

Cas Number:

2230512-72-6

Molecular formula:

C7H17O3P

IUPAC Name:

Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate

Test material form:

liquid

Details on test material:

R&D level

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Housing: The animals were singly housed in suspended stainless steel caging, which
conforms to the size recommendations in the most recent Guide for the Care and Use
of Laboratory Animals (Natl. Res. Council, 2011). Enrichment (e.g., toy) was placed
in each cage. Litter paper was placed beneath the cage and was changed at least
three times per week.
Animal Room Temperature and Relative Humidity Ranges: 20-23°C and 31-56%,
respectively.
Animal Room Air ChangeslHour: 12. Airflow measurements are evaluated regularly
and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 19 or 20 days
Food: Envigo Teklad Global 16% Protein Rodent Diet® #2016. The diet was
available ad libitum.
Water: Filtered tap water was supplied ad libitum.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Two thousand milligrams of the test substance per kilogram of body weight was applied evenly
over a dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface)
and covered with a 2-inch x 3-inch, 4-ply gauze pad. The gauze pad and entire trunk of each
animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to
minimize loss of the test substance. The rats were then returned to their designated cages. The day
of application was considered Day 0 ofthe study.
After 24 hours of exposure to the test substance, the pads were removed and the test sites were
gently cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove
any residual test substance.

Duration of exposure:

24 hours

Doses:

2000 mg /kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

Two thousand milligrams of the test substance per kilogram of body weight was applied to the
skin of ten healthy rats for 24 hours. The animals were observed for mortality, signs of gross
toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded
prior to application (initial) and again on Days 7 and 14 (terminal). Necropsies were performed
on all animals at terminal sacrifice.

Statistics:

Statistical analysis was limited to the calculation of the mean density value for dosing.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No

Clinical signs:

other: All animals survived test substance administration and gained body weight during the study. Apart from one animal exhibiting erythema on Day I, there were no other adverse clinical findings recorded for any animals over the course of the study. No gross a

Gross pathology:

No gross abnormalities were
noted for any of the animals when necropsied at the conclusion of the l4-day observation period See attached table 3

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

other: Not subject to classification under GHS

Conclusions:

Under the conditions of this study, the single dose acute dermal LD50 ofE17-194T is greater than
2000 mg/kg of body weight in male and female rats.

Executive summary:

SUMMARY

An acute dermal toxicity test was conducted with rats to determine the potential for

E17-194T to produce toxicity from a single topical application. Under the conditions of this

study, the single dose acute dermal LDso of the test substance is greater than 2000 mg/kg of body

weight in male and female rats.

Two thousand milligrams of the test substance per kilogram of body weight was applied to the

skin of ten healthy rats for 24 hours. The animals were observed for mortality, signs of gross

toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded

prior to application (initial) and again on Days 7 and 14 (terminal). Necropsies were performed

on all animals at terminal sacrifice.

All animals survived test substance administration and gained body weight during the study.

Apart from one animal exhibiting erythema on Day I, there were no other adverse clinical

findings recorded for any animals over the course of the study. No gross abnormalities were

noted for any of the animals when necropsied at the conclusion of the l4-day observation period.