2-hexyldecanoic acid [4-(6-tert-butyl-7-chloro-1H-pyrazolo[1,5-b][1,2,4]triazol-2-yl)phenylcarbamoyl]methylester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 - 28 Aug 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

adopted August 1998

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Nov 2000 including the most recent partial revisions

Deviations:

no

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): UM-235
- Physical state: white powder
- Lot/batch No.: #SI-1
- Expiration date of the lot/batch: 01 Jan 2005
- Storage condition of test material: at room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: individually in cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (Charles River Maintenance Diet for Rabbits, Altromin) 100 g per day; pressed hay was provided twice per week
- Water: tap-water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.4 - 23.2 (actual range)
- Humidity (%): 40 - 96 (actual range)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 35.9 mg (35.6 - 36.0 mg) (corresponding to a volume of approximately 0.1 mL)

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 hours
Reading time points: 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of animal #1 and #2

Time point:

other: mean over 24, 48 and 72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Instillation of 35.9 mg test substance into one eye of three rabbits each resulted in irritation of the conjunctivae which was seen as mild redness and mild-moderate chemosis in 3/3 rabbits at the 1-hour reading time point. 1/3 animals had a slight discharge 1 hour after application. 24 hours after application mild redness of the conjunctivae was still visible in all animals. This irritation had completely resolved within 48 hours in 2/3 animals and within 72 hours in 1/3 animal. 1 hour after application remnants of the test substance were still visible in all tested eyes.

Any other information on results incl. tables

Table 1. Results of eye irritation study. 

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
1	1	1	2	1	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.0	0.0	0.0	Time to reversion	48.0	24.0	0.0	0.0
2	1	1	1	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.0	0.0	0.0	Time to reversion	48.0	24.0	0.0	0.0
3	1	2	1	0	0
	24	1	0	0	0
	48	1	0	0	0
	72	0	0	0	0
	average	0.67	0.0	0.0	0.0	Time to reversion	72.0	24.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified