imiprothrin (ISO); reaction mass of [2,5-dioxo-3-(prop-2-yn-1-yl)imidazolidin-1-yl]methyl (1R,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate and [2,5-dioxo-3-(prop-2-yn-1-yl)imidazolidin-1-yl]methyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 26 - February 9, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

428-790-6

EC Name:

-

Cas Number:

72963-72-5

Molecular formula:

C17H22N2O4

IUPAC Name:

[2,5-dioxo-3-(prop-2-yn-1-yl)imidazolidin-1-yl]methyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropane-1-carboxylate; [2,5-dioxo-3-(prop-2-yn-1-yl)imidazolidin-1-yl]methyl (1R,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropane-1-carboxylate

Test material form:

liquid: viscous

Details on test material:

Name: Imiprothrin
Appearance: viscous liquid
Colour: amber

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Number of Animals: 10
Sex: 5 Males and 5 Females. Females assigned to test were nulliparous and non-pregnant.
Species/Strain: Rats/Sprague-Dawley derived, albino
Age/Body Weight: Young adult (9 weeks)/males 280-310 grams and females 202-212 grams at experimental start.
Housing: The animals were singly housed in suspended stainless steel caging
Animal Room Temperature and Relative Humidity Ranges: 19-23ºC and 40-58%, respectively.
Animal Room Air Changes/Hour: 13. Airflow measurements are evaluated regularly and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 15 days
Food: adlibitum
Water: ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

On the day prior to application, a group of animals was prepared by clipping the dorsal area and the trunk.
Five 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 of the study.

Duration of exposure:

24 hours

Doses:

5000 milligrams of the test substance per kilogram of body weight.
Individual doses were calculated based on the initial body weights, taking into account the density (determined by PSL) of the test substance.

No. of animals per sex per dose:

10 (5 Males and 5 Females)

Details on study design:

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.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Gross pathology:

No signs of gross toxicity. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period

Other findings:

All animals appeared active and healthy during the study. There were no signs ofdermal irritation, adverse clinical effects, or abnormal behavior.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The single dose acute dermal LD50 of Imiprothrin TG is greater than 5000 mg/kg of body weight in male and female rats.