methyl (4-butanoyl-2,3-dichlorophenoxy)acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Similar to OECD 423.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

methyl (4-butanoyl-2,3-dichlorophenoxy)acetate

EC Number:

608-516-3

Cas Number:

30720-99-1

Molecular formula:

C13H14Cl2O4

IUPAC Name:

methyl (4-butanoyl-2,3-dichlorophenoxy)acetate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Ketoészter
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: organic
- Physical state: white crystalline
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other:

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 171.67 +/- 13.50 g (male), 152.33 +/- 15.58 g (female)
- Fasting period before study: 18 h
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1.5
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1 % methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 1 % methylcellulose
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Dose selection according to Deichmann-Le Blanck.
5 doses, 2-2 animals/dose.

Doses:

1000 mg/kg
2600 mg/kg
3600 mg/kg
4250 mg/kg
5000 mg/kg

No. of animals per sex per dose:

Dose selection (approximate LD50 test)
1000 mg/kg 2 male/2 female
2600 mg/kg 2 male/2 female
3600 mg/kg 2 male/2 female
4250 mg/kg 2 male/2 female
5000 mg/kg 2 male/2 female

Dose selection (LD50 test)
5000 mg/kg 6 female/6 male

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2 h, 4h, 24h, 48 h, 72 h and 7. day, 14. day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, relative organ weights, histopathology

Results and discussion

Preliminary study:

Dose Male Female
(mg/kg) (dead/alive) (dead/alive)
1000 ( -/2) symptom free survivors (-/2) symptom free survivors
2600 (- /2) symptom free survivors (-/2) symptom free survivors
3600 (- /2) symptom free survivors (-/2) symptom free survivors
4250 (-/2) survivors with symptoms (-/2) survivors with symptoms
5000 (-/2) survivors with symptoms (-/2) survivors with symptoms

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Doses Dead/Alive Time Doses Dead/Alive Time
(mg/kg) (mg/kg)
5000 -/6 - 5000 -/6 -

Clinical signs:

The rats hair were ruffled.
No food consumptions.

Body weight:

See tables at any other information, including tables.

Gross pathology:

From among the dissected animals we agreed in 3 males and two females bleeding stomach mucosa ulcer.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is not classified according to EU classifications.