α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-06-24 to 2005-07-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

2004

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

202

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile

EC Number:

410-400-0

EC Name:

α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile

Cas Number:

88671-89-0

Molecular formula:

C15H17ClN4

IUPAC Name:

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

Test material form:

solid: crystalline

Remarks:

light orange

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC
- Age at study initiation: Young adult
- Weight at study initiation: not given in the report
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Purina Certified High Fiber Rabbit Diet
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 69-70%RH
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: distilled water

Controls:

no

Amount / concentration applied:

0.5 g of the test item (0.77 g of the test mixture) was placed on a 1-inch x 1-inch, 4-ply gauze pad and applied on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad.

Duration of treatment / exposure:

4 hours

Observation period:

Individual dose sites were scored at approximately 30-60 minutes, 24, 48, and 72 hours after patch removal.

Number of animals:

3 (1 Male and 2 Females)

Details on study design:

TEST SITE
- Area of exposure: 6-cm^2 intact dose site on each animal
- Type of wrap if used: 3-inch Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently cleansed of any residual test substance
- Time after start of exposure: 4 hours after exposure

OBSERVATION TIME POINTS
approximately 30-60 minutes, 24, 48, and 72 hours after patch removal

SCORING SYSTEM:
Individual dose sites were scored according to the Draize scoring system (see Table 3 below)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

edema 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:

There was no edema observed at any treated site during this study. One hour after patch removal, all
three treated sites exhibited very slight erythema. The overall incidence and severity of irritation
decreased thereafter. All animals were free of dermal irritation by 72 hours.

Other effects:

All animals appeared active and healthy during the study.

Any other information on results incl. tables

Individual skin irritation scores are presented in Table 1. A summary of primary skin irritation scores is presented in Table 2. 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A primary skin irritation test was conducted with Myclobutanil according to OECD/ EC guidelines and GLP principles. Under the conditions of this study, Myclobutanil caused very slight erythema, which cleared by 72 hours.

Executive summary:

A primary skin irritation test was conducted with New Zealand albino rabbits to determine the potential for Myclobutanil to produce irritation after a single topical application. Under the conditions of this study, the test substance caused very slight erythema, which cleared by 72 hours. Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of three healthy rabbits for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al. There was no edema observed at any treated site during this study. One hour after patch removal, all three treated sites exhibited very slight erythema. The overall incidence and severity of irritation (maximum score 1) decreased thereafter. All animals were free of dermal irritation by 72 hours.