4-(4-chlorophenyl)-2-phenyl-2-[(1H-1,2,4-triazol-1-yl)methyl]butanenitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24-March-1987 to 31-March-1987.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-(4-chlorophenyl)-2-phenyl-2-[(1H-1,2,4-triazol-1-yl)methyl]butanenitrile

EC Number:

406-140-2

EC Name:

4-(4-chlorophenyl)-2-phenyl-2-[(1H-1,2,4-triazol-1-yl)methyl]butanenitrile

Cas Number:

114369-43-6

Molecular formula:

C19H17ClN4

IUPAC Name:

4-(4-chlorophenyl)-2-phenyl-2-[(1H-1,2,4-triazol-1-yl)methyl]butanenitrile

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Number of Animals: 6
- Sex: Male
- Source: Hazleton Research Animals, Denver, PA
- Age at study initiation: 12 weeks old
- Weight at study initiation: Body weights ranged from 3.1 to 3.2 kg
- Housing: Stainless steel cages (18"X24"x15") suspended above absorbent pan liners
- Diet: Purina Laboratory Rabbit Chow High Fiber Diet
- Water: Filtered tap water via automatic watering
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C
- Humidity (%): 40 to 60%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark and 12 hrs light

Test system

Type of coverage:

occlusive

Vehicle:

physiological saline

Amount / concentration applied:

0.5 g of the test material was mixed into a paste with 1.0 ml of 0.85% saline (1:2 W/V) and the paste was applied onto a 2-in. square guaze patch attached to a plastic-lined Elastoplast adhesive bandage which was then applied to the skin of the rabbit.

Duration of treatment / exposure:

4 hours

Number of animals:

6 male rabbits

Details on study design:

TEST SITE
- Area of exposure: The skin on the back of the rabbits.
- Type of wrap if used: Polyethylene sheet and a flannel cuff.

REMOVAL OF TEST SUBSTANCE
- Washing: The application site was wiped with water-soaked paper towels and then blotted dry.
- Time after start of exposure: 4 hours after start of exposure.

OBSERVATION TIME POINTS
1, 24, 48, and 72 hours and 7 days after patch removal.

SCORING SYSTEM:
The degree of irritation was scored according to the procedure of Draize et ale (J. Pharmacol. Exp. Therap~, 82, 377-390, 1944) (see table 2 below). In addition, all other skin reactions (e.g., blistering, pocketing, blanching) or signs of systemic toxicity, if any, were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No skin irritation (i.e., no erythema or edema) was evident during the study period. The results are included in Table 1 below.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The skin irritation potential of fenbuconazole was assessed in male New Zealand White rabbits, following OECD guideline 404. No skin irritation (i.e., no erythema or edema) was observed at any timepoint during the study period.