pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 Jul 1991 to 27 Jul 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Version / remarks:

1982

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-methyl-4-[(E)-[(pyridin-3-yl)methylidene]amino]-2,3,4,5-tetrahydro-1,2,4-triazin-3-one

EC Number:

602-927-1

Cas Number:

123312-89-0

Molecular formula:

C10H11N5O

IUPAC Name:

6-methyl-4-[(E)-[(pyridin-3-yl)methylidene]amino]-2,3,4,5-tetrahydro-1,2,4-triazin-3-one

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Hra:(NZW)SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2402 to 2590 g (for males), 2278 to 2598 g (for females).
- Housing: maintained individually in screen-bottom cages in temperature- and humidity-controlled quarters.
- Diet: a measured amount of High Fiber Rabbit Chow
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Animal husbandry and housing comply with standards outlined in the "Guide for the Care and Use of Laboratory Animals" (NIH publication number No. 86-23, revised 1985). Variations from the prescribed environmental conditions existed and were considered to have had no effect on the study outcome. No contaminants were expected to have been present in the feed or water which would have interfered with or affected the results of the study.

IN-LIFE DATES:
July 24 to July 27, 1991

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g of the moistened test material

VEHICLE
- Amount applied: moistened with 0.9% saline

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 animals/sex

Details on study design:

TEST SITE
- Area of exposure: back, shaved skin
- % coverage: not reported
- Type of wrap if used: The area of application was covered with a 2.5 x 2.5 cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap and secured with Elastoplast tape to provide a semi occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the 4 hour exposure period, the patches were removed and the test sites were washed using tap water and disposable paper towels. The test material was removed from the test sites as thoroughly as possible without irritating the skin.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
Thirty minutes after removal of the test material, the degree of erythema and oedema was read according to the Draize technique (recorded as the 4-hour score). Subsequent examinations were made at 24, 48, and 72 hours.

SCORING SYSTEM:
Method of calculation: see field ‘any other information on materials methods incl. tables’.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The average and individual values of the 4-, 24-, 48-, and 72-hour scores is 0.0.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this EPA 81-5 study, the test substance was determined to be non-irritating to the skin of albino rabbits (Hra: New-Zealand White SPF).

Executive summary:

The skin irritation potential of the test substance was determined in vivo according to the EPA OPP 81-5 test guideline and GLP principles. 0.5 g moistened test substance was administered to the shaved back of 3 male and 3 female adult albino rabbits (Hra: New-Zealand White SPF) for 4 hours under semi-occlusive conditions. After 4 hours the test item was removed using tap water and disposable paper towels. Scoring was performed at 0, 24, 48 and 72 hours after application according to the Draize system. No erythema or Oedema reactions were observed (the average of the 24-, 48- and 72-hour scores is 0.0). Therefore the test substance is considered to be not irritating to the skin.