(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1981)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

EC Number:

406-850-2

EC Name:

(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

Cas Number:

133855-98-8

Molecular formula:

C17 H13 Cl F N3 O

IUPAC Name:

1-{[(2R,3R)-3-(2-chlorophenyl)-2-(4-fluorophenyl)oxiran-2-yl]methyl}-1H-1,2,4-triazole

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Weight at study initiation: 259 males (+/- 20%), 217 g females (+/- 20%)
- Fasting period: At least 15 hours before the beginning of the study
- Housing: Single housing in steel wire mess cages Type DK-III
- Diet ad libitum: Kliba diet 343,
- Water ad libitum: Tap water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0,5%

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal and dorsolateral parts of the trunk (clipped at least 15 h before application)
- Application Area: 50 cm2
- Type of wrap if used: Semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: Skin was flushed with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 4 ml/kg bw
- Concentration: 50%

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations for clinical symptoms: Several times on first day, afterwards once daily.
- Frequency of observations for mortality: Several times on first day, afterwards twice on workday and once on holidays.
- Frequency of weighing: On first day, day 7 and day 13.
- Necropsy of survivors performed: Yes, all animals were sacrificed and subjected to gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: None of the treated animals died. No clinical symptoms were observed.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

Upon necropsy no macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal median lethal dose of the test substance is higher than 2000 mg/kg bw.

Executive summary:

The substance was tested for its potential acute hazard after 24-hour percutaneous exposure. The test method was based on EPA (FIFRA) and OECD 402 guidelines. GLP requirements were fulfilled.

5 male and 5 female Wistar rats were administered 2000 mg/kg bw by application of a 50% suspension of the test substance in 0.5% aqueous CMC to dorsal/dorsolateral parts of the trunk, covering the application site with a semi-occlusive dressing for 24 hours. After removal of the dressing the site was rinsed with warm water.

No clinical symptoms and no local findings were observed during the 14 days observation period. No mortality occurred. No abnormalities were detected during necropsy.

Thus, the LD50 (dermal) in rats is higher than 2000 mg/kg bw.