1,2,4-triazole

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

reliability scoring based on 2002 guideline

Deviations:

yes

Remarks:

Source, purity, chemical characteristics of test substance, temperature, light cycle, and humidity not provided; grading scale for irritation not reported

GLP compliance:

no

Remarks:

study pre-dates GLP requirements

Test material

Test material information

Constituent 1

Reference substance name:

1,2,4-triazole

EC Number:

206-022-9

EC Name:

1,2,4-triazole

Cas Number:

288-88-0

Molecular formula:

C2H3N3

IUPAC Name:

1H-1,2,4-triazole

Details on test material:

- Name of test material (as cited in study report): 1,2,4-triazole
- Analytical purity: reported as technically pure

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: from the breeder Winkelmann (Borchen)
- Age at study initiation: no data
- Weight at study initiation: 3-4kg
- Fasting period before study: no data
- Housing: singly in standard rabbit cages
- Diet (e.g. ad libitum): Rabbit food 222 (Hoeing co.), ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Test article was instilled into the conjuctival sac of the left eye of 2 rabbits at a dose of 50 mg/animal.

Duration of treatment / exposure:

Single administration

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

2 rabbits

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: (1 rabbit)

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

2 rabbits

Time point:

24/48 h

Score:

0.5

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: (1 rabbit)

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

2 rabbits

Time point:

24/48 h

Score:

2.5

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

2 rabbits

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: (1 rabbit)

Irritant / corrosive response data:

One hour after application intense reddening and a very intense swelling of the conjectivae of the treated eyes had developed. 24 hours after application intense reddening and moderate swelling of the conjuctivae was still present. In one animal, there was still slight redness and swelling of the conjuctivae 5 days after application, while it was normal in the other animal. The conjuctivae of both animals were normal after 7 days. During the first and second days after application, a slight, dispersed, diffuse opacity of the cornea was observed. The iris was slightly reddened and swollen.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The authors concluded that 1,2,4-triazole has a irritant effect on the mucous membrane.

Executive summary:

A non GLP comparable Guideline 405 (Acute Eyes Irritation / Corrosion) test was carried out with 1,2,4 -triazole.

Undiluted test article was instilled into the conjuctival sac of the left eye of 2 rabbits at a dose of 50 mg/animal.

One hour after application intense reddening and a very intense swelling of the conjectivae of the treated eyes had developed. 24 hours after application intense reddening and moderate swelling of the conjuctivae was still present. In one animal, there was still slight redness and swelling of the conjuctivae 5 days after application, while it was normal in the other animal. The conjuctivae of both animals were normal after 7 days. During the first and second days after application, a slight, dispersed, diffuse opacity of the cornea was observed. The iris was slightly reddened and swollen.

Under the experimental conditions, the test substance is irritant and is classified in category 2 according to regulation EC no.1272/2008 (CLP).