2,4,6-tribromophenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4,6-tribromophenol

EC Number:

204-278-6

EC Name:

2,4,6-tribromophenol

Cas Number:

118-79-6

Molecular formula:

C6H3Br3O

IUPAC Name:

2,4,6-tribromophenol

Test material form:

solid: granular

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 950225
- Purity test date: 99%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.84 to 3.3 kg
- Housing: individually in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet, ad libitum
- Water: ad ibitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 43-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

no

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

Single treatment

Observation period (in vivo):

1, 24, 48 and 72-hours and 7-days and 14-days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: NA

SCORING SYSTEM: Draize (1977); interpretation done according to Kay and Calandra System and according to Annex VI of Council Directive 67/548/EEC

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.77

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.77

Max. score:

4

Reversibility:

fully reversible

Any other information on results incl. tables

------------------------------------------------------------------------------------------

Rabbit No.       Time after        Corneal       Iridial              Cojunctival       Cojunctival

and sex              treatment       Opacity       Inflammation       Redness        Chemosis

------------------------------------------------------------------------------------------

1 male              24 hrs                  1              1                            2                     2

1 male              48 hrs               1              1                            2                     2

1 male              72 hrs               1              0                            2                     2

total(mean)                                 3 (1.0)     2 (0.7)                  6 (2.0)            6 (2.0+)

------------------------------------------------------------------------------------------

2 male              24 hrs                  1              1                            2                     2

2 male              48 hrs                  1              1                            2                     2

2 male              72 hrs               1              0                            2                     1

total(mean)                             3 (1.0)       2 (0.7)                  6 (2.0)             5 (1.7)

-----------------------------------------------------------------------------------------

3 male              24 hrs                1              1                             2                     2

3 male               48 hrs               1              1                            2                     2

3 male              72 hrs               1              1                            2                     1

total(mean)                              3 (1.0)       1 (1.0+)                6 (2.0)              5 (1.7)

------------------------------------------------------------------------------------------

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the conditions of this study 2,4,6-TBP produced a positive response of corneal opacity of 1, iritis of 0.77, conjunctival redness of 2 and conjunctival oedema (chemosis) of 1.77 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material and fully reverses within the observation period.
According to the eye irritation classification system and the EU labelling regulations 2,4,6-TBP is classified as irritating to eyes Cat. 2.