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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

In life phase: 26 March 1996 - 9 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:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

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 material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS)
- Source: Harlan Winkelmann GmbH
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 178-183 g (M), 171-174 g (F)
- Fasting period before study: 17 hours
- Housing: group housing by sex
- Diet: ad libitum during the study
- Water: ad libitum
- Acclimation period: at least five days

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

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

Carboxymethyl-cellulose Sodium salt

Details on oral exposure:

The test substance was formulated in Carboxymethyl-cellulose Sodium salt 0.5 % before administration. The applied formulations were well mixed and then applied, single administration by gavage to fasted Wistar rats (Hsd Cpb: WU(SPF-bred)): 2000 mg/kg bw, application volume: 10 mL/kg bw.

Doses:

A volume of 10 ml/kg body weight was administered.

No. of animals per sex per dose:

3/sex/group

Control animals:

no

Remarks:

Not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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.
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight, organ weights, histopathology.

Statistics:

Not required

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50 cut-off

Effect level:

2 500 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities.

Clinical signs:

other: other: A dose of 2000 mg/kg bw of Spirodiclofen was tolerated by Wistar rats of both sexes without clinical signs

Gross pathology:

No treatment-related findings.

Any other information on results incl. tables

Findings:

Dose [mg/kg bw]	Toxicological results*			Duration of signs	Time of death	Mortality [%]
male	male			male	male	male
2000	0	0	3	-	-	0
LD50: > 2000 mg/kg bw
Female	Female			Female	Female	Female
2000	0	0	3	-	-	0
LD50: > 2000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Spirodiclofen does not require classification for acute oral 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 draft OECD 423 guideline.  Groups of male and female Wistar rats (3/sex) were administered single gavage doses of spirodiclofen (in aqueous carboxymethylcellulose) at the limit dose of 2000 mg/kg bw and were observed for 14 days.  There were no deaths, no signs of toxicity and no effects on body weight.  Gross necropsy did not reveal any effects of treatment.  The acute oral LD50 of spirodiclofen was therefore found to be >2000 mg/kg bw under the conditions of this study (OECD 423 LD50 cut-off =2500 mg/kg bw).  Spirodiclofen does not therefore require classification for acute oral toxicity according to the CLP Regulation on the basis of this study.