1-hydroxybenzotriazole

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from peer-reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Acute Toxicologic Evaluation of the given test chemical.

Author:

Montgomery et al.

Year:

1992

Bibliographic source:

International Journal of Toxicology

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Primary eye irritation study was performed on male New Zealand White rabbits to assess the irritation potential of the test chemical

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-hydroxybenzotriazole

EC Number:

219-989-7

EC Name:

1-hydroxybenzotriazole

Cas Number:

2592-95-2

Molecular formula:

C6H5N3O

IUPAC Name:

1H-1,2,3-benzotriazol-1-ol

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): 1- Hydroxybenzotriazole hydrate
- Molecular formula: C6H5N3O
- Molecular weight: 135.126 g/mol
- Substance type: Organic
- Physical state: Solid, crystalline powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01g (10 mg) undiluted test sample.

Duration of treatment / exposure:

Duration of exposure: 20 secs (rinsed eyes)
Duration of treatment: 7 days (unrinsed eyes)

Observation period (in vivo):

2 and 4 hours, and at 1, 2, 3, and 7 days

Number of animals or in vitro replicates:

2 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, Approximately 20 seconds after the test material was administered, both eyes of 1 rabbit were rinsed for 1 minute with water.
- Time after start of exposure: 20 seconds after the test material was administered.

SCORING SYSTEM: According to the method of Draize

TOOL USED TO ASSESS SCORE: A biomicroscope and fluorescein stain were used at examinations beginning the day after treatment.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Reversibility:

fully reversible within: 7 days

Remarks:

in the unrinsed eyes

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

Both treated eyes initially showed mild conjunctival redness and chemosis with one instance of blood-tinged discharge; these effects resolved by 2 days in the rinsed eye and by 7 days in the unrinsed eye. Mild generalized opacity of the cornea was observed on the day of treatment in the unrinsed eye.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Both treated eyes initially showed mild conjunctival redness and chemosis with one instance of blood-tinged discharge; these effects resolved by 2 days in the rinsed eye and by 7 days in the unrinsed eye. Mild generalized opacity of the cornea was observed on the day of treatment in the unrinsed eye.
Hence, under the experimental test conditions it was concluded that the test chemical was considered to be mildly irritating to the eyes of rabbits and being classified as “Irritating to eyes in Category 2” as per CLP Regulation.

Executive summary:

Primary eye irritation study was conducted on 2 male New Zealand White rabbits to assess the irritation potential of the test chemical. 0.01 g (10mg) of the undiluted test chemical was instilled into the lower conjunctival sac of the right eyes of 2 male New Zealand White rabbits. The left eye served as control. Approximately after 20 seconds of test material administration, both eyes of 1 rabbit were rinsed for 1 minute with water; the eyes of the other rabbit were not rinsed. Irritation was scored at 2 and 4 hours, and at 1, 2, 3, and 7 days. Biomicroscope and fluorescein stains were used at examinations beginning the day after treatment.

Both treated eyes initially showed mild conjunctival redness and chemosis with one instance of blood-tinged discharge; these effects resolved by 2 days in the rinsed eye and by 7 days in the unrinsed eye. Mild generalized opacity of the cornea was observed on the day of treatment in the unrinsed eye.

Hence, under the experimental test conditions it was concluded that the test chemical was considered to be mildly irritating to the eyes of rabbits and being classified as “Irritating to eyes in Category 2” as per CLP Regulation.