Registration Dossier

Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.77
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
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

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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)

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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.