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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC B.4.

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Leuschner, Germany
- Age at study initiation: ~5 months
- Weight at study initiation: 1.9-2.0 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: 21 March 1996 To: 24 March 1996

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg (moistened with water)

Duration of treatment / exposure:

The duration of exposure was 4 hours

Observation period:

Skin irritation was assessed at 1-, 24-, 48-, 72 hours after exposure.

Number of animals:

3 Rabbits were used in the study

Details on study design:

500 mg spirodiclofen was moistened with water, applied to the test site and covered with a gauze patch to the skin (area: approx. 6 cm²). The patch was held in contact with the skin by a semi-occlusive dressing. The duration of exposure was 4 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no irritating effects.

Remarks on result:

no indication of irritation

Remarks:

None of the rabbits showed irritation at 24, 48 or 72 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no irritating effects

Remarks on result:

no indication of irritation

Remarks:

None of the rabbits showed irritation at 24, 48 or 72 hours

Irritant / corrosive response data:

Not applicable: there were no signs of irritation at any time point

Any other information on results incl. tables

Skin irritation scores:

	1h	1h	24h	24h	48h	48h	72h	72h	7d	7d	14d	14d	Irrit. Index	Irrit. Index
Animal No.	e	oe	e	oe	e	oe	e	oe	e	oe	e	oe	e	oe
1	0	0	0	0	0	0	0	0	-	-	-	-	0.0	0.0
2	0	0	0	0	0	0	0	0	-	-	-	-	0.0	0.0
3	0	0	0	0	0	0	0	0	-	-	-	-	0.0	0.0

0 = no pathological findings; - = not examined; d = day; e = erythema and eschar formation; h = hour, -s;
oe = oedema formation

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

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

Conclusions:

There was no evidence of skin irritation in this study.

Executive summary:

The skin irritation/corrosion potential of spirodiclofen was investigated in a study in three rabbits, performed according to OECD 404.  The study predates the adoption of in vitro tests for the assessment of skin corrosion and skin irritation.  0.5 g of spirodiclofen (moistened with water) was applied for fhour hours under occlusive conditions to the shorn skin of three Himalayan rabbits.  Local dermal 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 a skin irritant according to the CLP criteria, on the basis of this study.