Registration Dossier

Diss Factsheets

Administrative data

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.

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 405 (Acute Eye Irritation / Corrosion)
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: solid (powder)
- Analytical purity: =99%
- Lot/batch No.: 92/492
- Storage condition of test material: room temperature, away from light
-Expiration date of lot/batch: after 1995

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Chemosis
Basis:
animal #1
Time point:
other: 1 hour
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: 1 hour
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:
conjunctivae score
Remarks:
Chemosis
Basis:
animal #1
Time point:
other: 24 hour
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: 24 hour
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 hour
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: 24 hour
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:
other: 24 hour
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Chemosis
Basis:
animal #1
Time point:
other: 48 hour
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: 48 hour
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 48 hour
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: 48 hour
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:
other: 48 hour
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal #1
Time point:
other: 72 hour
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 72 hour
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 72 hour
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: 72 hour
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:
other: 72 hour
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

Applicant's summary and conclusion

Interpretation of results:
Category I
Remarks:
Migrated information Causes serious eye damage. 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 batch 92/492 can be classified among the substances which are corrosive for the eye.
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 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.