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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

In-life: 26-March-1996 to 09-April-1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

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 material form:

solid: particulate/powder

Remarks:

white appearance

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks (M), >16 weeks (F)
- Weight at study initiation: 251-269 g (M), 224-243 g (F)
- Fasting period before study: None
- Housing: Single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-23.5
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26 March 1996 To: 9 April 1996

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

sterile demineralized water

Details on dermal exposure:

For each dose and animal, the solid test substance was weighed onto an aluminum foil used to cover the administration site. The test substance was then mixed to a paste with 0.8 ml of sterile demineralized water per gramm test substance and applied to the intact dorsal skin, shorn on the previous day, of 5 rats per dose and sex, respectively. The foil was fixed in place on the skin with an occlusive dressing (fermoflex®). On removal of the dressings the treated skin sites were cleaned with soap and water.

Duration of exposure:

Exposure lasted for 24 hours.

Doses:

2000 mg/kg bw for all test animals

No. of animals per sex per dose:

5 rats per sex per dose

Control animals:

no

Details on study design:

Clinical Observation: Appearance and behavior was recorded several times on the day of treatment, and at least once a day thereafter. Where signs occurred, the type, period and intensity (1 = weak, 2 = moderate, 3 = strong) were determined individually. In the annex they are shown as individual, group and summary findings. Where mortalities occurred, the time recorded was the time the death animal was first noted. On the day of administration, the times reported relate to the time of administration (day 1 of the test). In order to obtain a clearer picture reported times over one hour have been rounded to the nearest full hour. Reported times less than one hour have been rounded to the nearest five minutes. The times reported are the time when the sign first appeared and the time when the sign was last observed. The days recorded are test days.

During clinical observation all abnormal findings were registered and particular attention is paid to the following organ systems, localizations and physiological functions:

Appearance: fur, skin color, edemas, eyes, lacrimation, nasal discharge, salivation etc.
Behavior: grooming, vocalization, excitement, aggression, digging and preening movements, cannibalism etc.
Nervous system: reactivity, motility, reflexes, gait, paralysis, spasms, tremors etc.
Respiration: where assessable, frequency etc.
Cardiovascular system: where assessable, heart rate, pallor etc.
Posture: ventral, lateral recumbency etc.
Gastrointestinal functions: appearance of feces etc.

The post-treatment observation period lasted 14 days. The body weights of the rats are recorded on day 1 before administration and then weekly. Additionally, all animals that died or are sacrificed are weighed. At the end of the post-treatment observation period the animals are anesthetized by inhaling diethyl ether and sacrificed. They are then subjected to a gross pathology examination, as are any animals which may have died intercurrently.

Statistics:

Not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

There was no mortality

Clinical signs:

other: other: There were no signs of systemic toxicity and no evidence of local dermal irritation at the application site.

Gross pathology:

Gross necropsy did not reveal any effects of treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Spirodiclofen does not require classification for acute dermal toxicity according to the CLP criteria on the basis of this study.

Executive summary:

The acute oral toxicity of spirodiclofen was investigated in the rat, according to the OECD 403 guideline.  Groups of male and female Wistar rats (5/sex) were administered single dermal doses of spirodiclofen at the limit dose of 2000 mg/kg bw and were observed for 14 days.  There were no deaths, no signs of toxicity or local dermal irritation and no effects on body weight.  Gross necropsy did not reveal any effects of treatment.  The acute dermal LD50 of spirodiclofen was therefore found to be >2000 mg/kg bw under the conditions of this study.  Spirodiclofen does not therefore require classification for acute dermal toxicity according to the CLP Regulation on the basis of this study.