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Diss Factsheets

Administrative data

Description of key information

Skin irritation : Study according to OECD guideline (404) - Na1.2.4-triazole was a non skin irritant.
Eye irritation : Study according to OECD guideline (405) - Na1.2.4-triazole was a severe eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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
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
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
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
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
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Jul. 13, 1992 to Aug. 11, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405). No GLP study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: COB.LABO.LAP farm at 22120 YFFINIAC (FRANCE)
- Age at study initiation: Not reported
- Weight at study initiation: 2.5 g
- 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
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light):Not reported


IN-LIFE DATES: From: July 13, 1992 To: July 16, 1992
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (~80 mg)

Duration of treatment / exposure:
single exposure
Observation period (in vivo):
for 72 hours
Number of animals or in vitro replicates:
1 animal
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: Not applicable

SCORING SYSTEM: Draize criteria

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1 hour
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #1
Time point:
other: 1 hour
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
cornea opacity score
Remarks:
surface of corneal opaqueness
Basis:
animal #1
Time point:
other: 1 hour
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
withing 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #1
Time point:
24 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
cornea opacity score
Remarks:
surface corneal opaqueness
Basis:
animal #1
Time point:
24 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
48 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #1
Time point:
48 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
cornea opacity score
Remarks:
surface corneal opaqueness
Basis:
animal #1
Time point:
48 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #1
Time point:
72 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
cornea opacity score
Remarks:
surface corneal opaqueness
Basis:
animal #1
Time point:
72 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritant / corrosive response data:
Important and non reversible irritation reactions are observed on the rabbit's treated eye:
1. to the level of the conjunctiva: tumefaction with eyelids more than half closed and intense hyperhemia.
2. iris discernible with difficulty, absence of reaction to light, important haemorrhage visible.
3. opacity in the whole area of the cornea on all surface.
Other effects:
no
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

One eye of one rabbit was exposed 80 mg of 1,2,4-Triazole sodium salt according to the OECD 405 guideline. The substance caused serious eye damage, and these phenomena were not reversible in 72 hours. Each scores were estimated according to the criteria of Draize. For each item, at each time, the score was the maximal score. According CLP criteria, the susbtance is classified as category 1 (irreversible effects on the eye).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Additional information

Skin irritation (Study of Dufour 1992) :

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 at the 24, 48 and 72 hours time points observation.

Eye irritation (Study of Dufour 1992) :

One eye of one rabbit was exposed 80 mg of 1,2,4-Triazole sodium salt according to the OECD 405 guideline. The substance caused serious eye damage, and these phenomena were not reversible in 72 hours. Each scores were estimated according to the criteria of Draize. For each item, at each time, the score was the maximal score.

Important and non reversible irritation reactions are observed on the rabbit's treated eye: to the level of the conjunctiva: tumefaction with eyelids more than half closed and intense hyperhemia, iris discernible with difficulty, absence of reaction to light, important haemorrhage visible, and, opacity in the whole area of the cornea on all surface.


Effects on eye irritation: highly irritating

Justification for classification or non-classification

According to EU regulation (EC) No 1272/2008 (CLP) :


Skin irritation : 1,2,4-Triazole sodium salt was not classified (mean score < 2.3).


Eye irritation : 1,2,4-Triazole sodium salt was classified as eye irritant in category 1. Because: effects on the cornea, iris and conjunctiva were not fully reversible in 72 hours, and there are a positive response of cornea opacity (>3), and iritis (>1.5) calculated as the mean scores following grading at 1, 24, 48, and 72 hours after installation of the substance.


 


 


To sum up, 1,2,4-Triazole sodium salt was a non skin irritant, but a severe eye irritant.