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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
Study period:
13 Dec - 16 Dec 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
adopted 1998
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(5-hydroxy-1,3-dimethyl-1H-pyrazol-4-yl)[2-(methylsulfonyl)-4-(trifluoromethyl)phenyl]methanone
EC Number:
609-256-3
Cas Number:
365400-11-9
Molecular formula:
C14H13F3N2O4S
IUPAC Name:
(5-hydroxy-1,3-dimethyl-1H-pyrazol-4-yl)[2-(methylsulfonyl)-4-(trifluoromethyl)phenyl]methanone
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was instilled as received.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC, USA
- Age at study initiation: Young adult
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors.
- Diet: Pelleted Purina Rabbit Chow #5326
- Water: Filtered tap water was supplied ad-libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13 Dec 2005 To: 16 Dec 2005

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 40 mg (corresponding to 0.1 mL)
Duration of treatment / exposure:
single exposure, no washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Duration of post- treatment incubation (in vitro):
not applicable
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done
SCORING SYSTEM: scoring was done according to Draize

TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light (Mag Lite). A fluorescein dye evaluation was performed 24 h after instillation and as needed at subsequent scoring intervals to evaluate the extent of corneal damage or to verify reversal of effects.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1 and animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no indication of corneal opacity
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1 and animal # 3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within:
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no indication of iritis
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all aniamls
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no indication of chemosis
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2 and animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritant / corrosive response data:
One hour after test substance instillation, all three treated eyes exhibited iritis and conjunctivitis. By 24 h, corneal opacity (score 1) developed in one animal. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation by 72 h.
Ocular discharge (score 2) was noted 1 h after treatment and to a lesser degree (score 1) 24 h after treatment in all animals. In animal #3 this discharge persisited until 48. The finding was fully reversible in all animals within 72 h.


Other effects:
All animals appeared active and healthy during the study. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.

Any other information on results incl. tables

Table 1: Individual irritation scores

Animal number

Effects

1 h

24 h

48 h

72 h

Mean scores*

1

Corneal opacity

Iritis

Redness conjunctivae

Chemosis conjunctivae

Discharge

0

1

3

1

2

0

1

2

0

1

0

0

1

0

0

0

0

0

0

0

0.00

0.33

1.00

0.00

0.33

2

Corneal opacity

Iritis

Redness conjunctivae

Chemosis conjunctivae

Discharge

0

1

2

1

2

0

0

2

1

1

0

0

1

0

1

0

0

0

0

0

0.00

0.00

1.00

0.33

0.67

3

Corneal opacity

Iritis

Redness conjunctivae

Chemosis conjunctivae

Discharge

0

1

3

2

2

1

1

2

1

1

1

0

1

1

1

0

0

0

0

0

0.67

0.33

1.00

0.67

0.67

* calculated from 24 to 72 h scores

Applicant's summary and conclusion

Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008"
Conclusions:
CLP: not classified