spirodiclofen (ISO);3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 March 1996 - 25 September 1997

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(3,5-Dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate

Cas Number:

148477-71-8

Molecular formula:

C21H24Cl2O4

IUPAC Name:

3-(3,5-Dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Leuschner, Germany
- Age at study initiation: ~5 months
- Weight at study initiation: 2.1-2.6 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 30-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 March 1996 To: 29 March 1996

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Spirodiclofen:
A dose of 100 mg Spirodiclofen/rabbit was administered into the conjunctival sac of the right eye

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and also 1, 24, 48 and 72 hours after the administration.
The eye reactions were observed and registered. 24 hours after administration the eyes were treated additionally with fluorescein and examined.

Number of animals or in vitro replicates:

Three

Details on study design:

24 hours after administration the eyes were treated additionally with fluorescein and examined using a slit lamp.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Under the test conditions a single application of 100 mg Spirodiclofen per animal into the conjunctiva! sac of the right eye of three rabbits did not cause any changes.
The cornea, iris and conjunctiva were not affected by the instillation of the test compound.
There were no systemic intolerance reactions

Any other information on results incl. tables

Findings: 

			Draize grades
Animal No.	Tissue	Signs	1h	24h	48h	72h	7d	14d	21d	Irrit. index
1	cornea	o	0	0	0	0	-	-	-	0.0
		a	0	0	0	0	-	-	-
	fluorescein	i	-	0	-	-	-	-	-
		a	-	0	-	-	-	-	-
	iris		0	0	0	0	-	-	-	0.0
	conjunctivae	r	0	0	0	0	-	-	-	0.0
		c	0	0	0	0	-	-	-	0.0
2	cornea	o	0	0	0	0	-	-	-	0.0
		a	0	0	0	0	-	-	-
	fluorescein	i	-	0	-	-	-	-	-
		a	-	0	-	-	-	-	-
	iris		0	0	0	0	-	-	-	0.0
	conjunctivae	r	0	0	0	0	-	-	-	0.0
		c	0	0	0	0	-	-	-	0.0
3	cornea	o	0	0	0	0	-	-	-	0.0
		a	0	0	0	0	-	-	-
	fluorescein	i	-	0	-	-	-	-	-
		a	-	0	-	-	-	-	-
	iris		0	0	0	0	-	-	-	0.0
	conjunctivae	r	0	0	0	0	-	-	-	0.0
		c	0	0	0	0	-	-	-	0.0

- = not examined; i = intensity; a = area; o = opacity; d = day; r = redness; h = hour; c = chemosis

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Spirodiclofen is not classified as an  eye irritant according to the CLP criteria, on the basis of this study.

Executive summary:

The eye irritation potential of spirodiclofen was investigated in a study in three rabbits, performed according to OECD 405.  The study predates the adoption of in vitro tests for the assessment of eye irritation.  0.1 g of spirodiclofen was instilled into one eye of three Himalayan rabbits.  Ocular reactions were scored at 24, 48 and 72 hours after application, using the Driaze scale.  There were no signs of irritation in any rabbit at any time point.  Spirodiclofen is not classified as an  eye irritant according to the CLP criteria, on the basis of this study.