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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:
no

Test material

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48, 72 hours
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 the 67/548/EEC order classification, 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 67/548/EEC order classification, the substance 1,2,4-Triazole sodium salt can be classified among the substances which are non irritant for the skin.