1H-1,2,4-triazole, sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Jul. 1, 1992 to Aug. 11, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 404). No GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Year of guideline followed not reported, reliability scoring based on 2002 guideline.

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1H-1,2,4-triazole, sodium salt

EC Number:

255-280-9

EC Name:

1H-1,2,4-triazole, sodium salt

Cas Number:

41253-21-8

Molecular formula:

C2H3N3.Na

IUPAC Name:

sodium 1,2,4-triazol-1-ide

Details on test material:

- Name of test material (as cited in study report): 1, 2, 4 - TRIAZOLE, SODIUM SALT
- Physical state: White-yellow powder
- Analytical purity: =99%
- Lot/batch No.: 92/492
- Expiration date of the lot/batch: after 1995
- Storage condition of test material: in dark and cool dry place

Test animals

Species:

rabbit

Strain:

other: Albino New Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: COB.LABO.LAP farm at 22120 YFFINIAC (FRANCE)
- Age at study initiation: not reported
- Weight at study initiation: 2.6 kg (average)
- Housing: individual housing on floor grid
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS: In accordance with the requirements of the 86/609/EEC guideline.
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

At 1, 24, 48, and 72 hr after patch removal (additional observations at 4 and 5 days after patch removal).

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: the right flank
- % coverage: not reported
- Type of wrap if used: the animal's trunk is wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width, place in such a way so as not to hinder respiratory movements.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): test site is washed as needed with distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: assessed according to the criteria of Draize.

Erythema and scab formation
No erythema .................................. 0
Slight erythema (barely visible )............. 1
Visible erythema ............................. 2
Substantial erythema ......................... 3
Serious erythema (purple red) with or without
slight scab formation (profound lesions) ..... 4

Edema formation
No edema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight edema (barely visible) ........... 1
Slight edema (clearly defined contours, obvious swelling) ............................ 2
Moderate edema (thickness of about 1 mm) .... 3
Serious edema (more than 1 mm in thickness and a surface greater than the application zone). 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritant / corrosive response data:

A slight irritation reaction was observed on the three rabbits' skin. These phenomena were totally reversible in 5 days.

Other effects:

no

Applicant's summary and conclusion

Interpretation of results:

other: Not classified.

Remarks:

Criteria used for interpretation of results: other: CLP (EC1272/2008)

Conclusions:

According to regulation EC 1272/2008, the substance 1,2,4-Triazole sodium salt can be classified among the substances which are non irritant for the skin.

Executive summary:

Three rabbits were exposed by dermal route (semiocclusive) to 1,2,4-Triazole sodium salt during 4 hours according to the OECD 404 guideline. A slight irritation reaction was observed on the three rabbits' skin. These phenomena were totally reversible in 5 days. Erythema and edema scores were estimated according to the criteria of Draize. For each score and each animal, the score were between 0 and 1. According to the Regulation EC 1272/2008, the substance 1,2,4-Triazole sodium salt can be classified among the substances which are non irritant for the skin.