benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 January 2010 to 20 January 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undeca-2,4,6-trien-3-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide

EC Number:

691-719-4

Cas Number:

1072957-71-1

Molecular formula:

C18H15Cl2F2N3O

IUPAC Name:

N-[11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undeca-2,4,6-trien-3-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide

Details on test material:

- Name of test material (as cited in study report): SYN545192 tech.
- Physical state: Beige powder
- Analytical purity: 97.0% (by HPLC)
- Purity test date: 25 February 2009
- Expiration date of the lot/batch: End February 2013
- Storage condition of test material: <30°C

Test animals

Species:

rat

Strain:

other: CRL:(WI)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 200-299 g
- Fasting period before study: Not applicable
- Housing: Individually in Type II polypropylene cages
- Diet: ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance ad libitum
- Water: Municipal tap water ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30-70%
- Air changes: 15-20 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 06 January 2010 To: 20 January 2010

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Shaved back
- % coverage: 10%
- Type of wrap if used: terile gauze pad, kept in contact with skin with a patch of adhesive hypoallergeic plaster and entire trunk wrapped with semi occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes with body temperature water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: No

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations made 1 and 5 6 hours after application and once each day for 14 days thereafter. Body weights recorded on days 0 (beginning of the experiment), 7 and 14
- Necropsy of survivors performed: Yes

Statistics:

Not applicable (limit test, no mortalities)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No adverse clinical or dermal signs

Gross pathology:

No macroscopic findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information no mortalities at limit dose of 2000 mg/kg bw Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of SYN545192 was greater than 2000 mg/kg bw in male and female CRL:(WI) BR rats.

Executive summary:

The acute dermal toxicity of SYN545192 was assessed in male and female CRL:(WI) BR rats. A single 24 hour dermal application was administered followed by a 14 day observation period. Animals were observed individually after dosing at 1 and 5 hours post treatment and once each day for 14 days thereafter. Body weight was measured on days 0, 7 and 14. All animals were examined macroscopically at the end of the study.

No mortality occurred. No adverse clinical or dermal signs were observed in any of the animals. There were no effects on bodyweight and no macroscopic findings at necropsy.

The acute dermal LD50 of SYN545192 was greater than 2000 mg/kg bw in male and female CRL:(WI) BR rats.