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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 10 - January 13, 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:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes (incl. QA statement)

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Sex: Female, nulliparous and non-pregnant.
Age/Body Weight: Young adult (13 weeks)/2683-2685 grams at experimental start.
Housing: The animals were singly housed in suspended stainless steel caging
Animal Room Temperature and Relative Humidity Ranges: 20-23ºC and 44-57%, respectively.
4nimal Room Air Changes/Hour: 12 or 13.
Photoperiod: 12-hour light/dark cycle
4cclimation Period: 20 days
Food:/water: ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Amount / concentration applied:

Five-tenths of a milliliter of the test substance was applied to one 6-cm2 intact dose site on each animal and covered with a 1-inch x 1-inch, 4-ply gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.

Duration of treatment / exposure:

4 hours

Observation period:

Individual dose sites were scored according to the Draize scoring system at approximately 30-60 minutes, 24, 48, and 72 hours after patch removal.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible

Any other information on results incl. tables

All animals appeared active and healthy and gained body weight during the study. Apart from the dermal irritation noted below, there were no other signs of gross toxicity, adverse clinical effects, or abnormal behavior.
Within 30-60 minutes of patch removal, all three treated sites exhibited very slight erythema. The overall incidence and severity of irritation decreased with time. All animals were free of dermal irritation by 72 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met