Pyrasulfotole

Eye irritation

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 09 Oct 2017 (corrected 14 Jun 2021)

Deviations:

yes

Remarks:

no pre-treatment with systemic analgesic and topical anesthesia

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

adopted 1998

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol

EC Number:

609-256-3

Cas Number:

365400-11-9

Molecular formula:

C14H13F3N2O4S

IUPAC Name:

4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol

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

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

Results

Results 1

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

Results 2

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

Results 3

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:

Results 4

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

Results 5

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

Results 6

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

Results 7

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:

The study was performed in accordance to EPA OPPTS 870.2400 (Acute Eye Irritation) under GLP conditions and is considered reliable. Based on the study results, the test substance is considered to be mildly irritating to eyes. However, the slight signs of irritation observed in this study were not sufficient to warrant classification for eye irritation.