5,7-dichloro-4-(4-fluorophenoxy)quinoline;quinoxyfen (ISO)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

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 OPP 81-2 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EEC Methods Number B.2 Acute Toxicity (Dermal)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF Acute Dermal Toxicity Study

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

124495-18-7

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Substance ID: TSN 100097
- Name of substance: XDE-795
- Lot number: DECO-97-152-1
- Purity: 97.4%

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc., Kalamazoo, Michigan
- Age at study initiation: Approximately 4 months
- Weight at study initiation: Male: 2317 ± 60 g; Female: 2421 ± 58 g
- Diet: Four ounces per day
- Water: ad libitum
- Acclimation period: At least two weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Humidity (%): 40-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: Trunk
- % coverage: Approximately 10%
- Type of wrap if used: Test substance impregnated gauze patch held in place by an elastic rabbit jacket

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was wiped thoroughly with water and dried with a soft disposable towel
- Time after start of exposure: 24 hours

TEST MATERIAL
- For solids, paste formed: Yes

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: Careful in-life observations were made and recorded frequently the day of dosing and at least once each work day throughout the two-week observation period. Routine monitoring on weekends was limited to animal husbandry procedures required to ensure the availability of feed and water. The rabbits were weighed pre-study, the day of treatment and on test days 3, 8 and 15.
- Necropsy of survivors performed: Yes

Statistics:

Means and standard deviations were calculated for body weights. The data were evaluated for statistical outliers by a sequential test, however, outliers were not routinely excluded from statistical analysis.

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:

other: limit dose

Mortality:

All rabbits survived

Clinical signs:

other: No in-life observations or clinical signs indicative of systemic toxicity were noted

Gross pathology:

There were no treatment-related observations made at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dermal LD50 (rabbits) > 2000 mg/kg (limit dose)

Executive summary:

The test substance was evaluated for dermal toxicity following OECD guideline 402 and EPA guideline 81-2. Five New Zealand White rabbits per sex received a single, 24-hour, dermal exposure of 2000 mg/kg of test substance. Parameters evaluated included body weights, in-life observations and gross pathologic evaluation.

All rabbits survived the 2000 mg/kg limit test established by the guidelines, therefore, no other dose levels were tested. All rabbits gained or maintained body weight during the two-week observation period.

No in-life observations or clinical signs indicative of systemic toxicity were noted. In addition, no treatment-related observations were made at necropsy.

Under the conditions of this study, the acute dermal LD50 of the test substance was greater than the 2000 mg/kg limit dose, for male and female New Zealand White rabbits.