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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1989

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Dust in air concentration determination is not reliable. Exact animal exposure can not be determined.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Principles of method if other than guideline:

Deviation from guideline: granulometry was not determined from the sample powder. Dust concentration in air was not measured by an approriate analitical method.

GLP compliance:

no

Test type:

other: acute inhalation toxicity sudy

Limit test:

yes

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):
- 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: soluble in propylene glycol, etylene glycol, DMSO

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:
- Fasting period before study: 12h
- Housing: 2-2 animals/cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

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

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

clean air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
- Exposure chamber volume: 0.3 m3
- Method of holding animals in test chamber: connecting to glass tubes in a 40 cm wall
- Source and rate of air:
- Method of conditioning air:
- System of generating particulates/aerosols:
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber:

TEST ATMOSPHERE
- Brief description of analytical method used: calculation
- Samples taken from breathing zone: yes/no

VEHICLE
- Composition of vehicle (if applicable): DMSO
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not determined
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not determined

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:

Analytical verification of test atmosphere concentrations:

no

Remarks:

only calculation

Duration of exposure:

4 h

Concentrations:

ALC

Concentration Gender Dead
3611 mg/m3; Male/Female --
4463 mg/m3; Male/Female --
5147 mg/m3; Male/Female --


LC50
1315 mg/m3; Male 0/8 --
Female 0/8 --

1894 mg/m3; Male 1/10 72 hours
Female 1/10 24 hours

2368 mg/m3 Male 1/10 48 hours
Female 1/10 48 hours

No. of animals per sex per dose:

8 males/8 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0; 1; 2; 3; 4; 7; 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, relative organ weights, histopathology

Results and discussion

Mortality:

No.

Clinical signs:

other: No.

Body weight:

Body weight gain of treated animals was the same as the control animals.

Gross pathology:

Mild hyperemia was observable on a smaller area of the lung

Any other information on results incl. tables

Body weight change after treatment in gramm (g)

Males (average value, n = 8)

Concentration (mg/m3)	0	1 day	2 day	3 day	7 day	14 day	Body weight increase (g)
3611	187.6 +/- 13.4	192.4 +/- 12.4	196.4 +/- 13.6	201.3 +/- 14.2	216.2 +/- 14.3	234.3 +/- 13.7	+46.7
4463	196.4 +/- 16.3	199.4 +/- 13.6	206.3 +/- 14.3	209.4 +/- 11.4	227.4 +/- 10.3	243.6 +/- 14.3	+47.2
5147	196.4 +/- 10.7	197.4 +/- 11.2	201.4 +/- 14.2	206.7 +/- 13.4	224.6 +/- 15.2	242.7 +/- 14.2	+46.3
Control	198.7 +/- 9.9	203.0 +/- 13.0	210.4 +/- 16.4	216.2 +/- 17.6	231.4 +/- 17.2	247.6 +/- 19.3	+48.9
Control (untreated)	203.4 +/- 11.4	209.4 +/- 17.4	214.3 +/- 14.4	220.0 +/- 19.4	238.4 +/- 119.2	253.2 +/- 21.4	+49.5

Females (average value, n = 8)

Concentration (mg/m3)	0	1 day	2 day	3 day	7 day	14 day	Body weight increase (g)
3611	187.3 +/- 16.3	189.4 +/- 13.7	193.2 +/- 14.2	199.7 +/- 13.8	217.3 +/- 12.7	231.1 +/- 13.7	+43.8
4463	193.2 +/- 12.7	197.3 +/- 13.2	203.2 +/- 12.7	206.4 +/- 13.7	220.4 +/- 11.2	240.2 +/- 14.3	+44.0
5147	194.3 +/- 13.7	197.1 +/- 12.7	201.0 +/- 10.7	206.2 +/- 13.2	221.3 +/- 13.7	238.0 +/- 13.9	+43.7
Control	177.5 +/- 12.8	177.4 +/- 16.3	183.1 +/- 17.1	187.5 +/- 19.8	110.0 +/- 20.9	222.5 +/- 19.5	+45.0
Control (untreated)	181.4 +/- 14.2	286.2 +/- 17.3	192.4 +/- 16.4	196.4 +/- 16.2	213.3 +/- 19.2	227.4 +/- 20.4	+46.0

 

Relative organ weight (100 g body weight) of male rats (average, n= 8)

Concentration (mg/m3)	Brain	Liver	Kidney	Lung	Heart	Spleen	Thymus	Adrenal
3611	0.52 +/- 0.04	3.97 +/- 0.21	0.32 +/- 0.03	057 +/- 0.03	0.32 +/- 0.02	0.21 +/- 0.04	0.16 +/- 0.03	0.01 +/- 0.002
4463	0.57 +/- 0.04	3.92 +/- 0.19	0.34 +/- 0.04	0.60 +/- 0.09	0.31 +/- 0.03	0.22 +/- 0.03	0.17 +/- 0.02	0.01 +/- 0.001
5147	0.56 +/-0.03	3.87 +/- 0.23	0.32 +/- 0.06	0.62 +/- 0.09	0.30 +/- 0.04	0.22 +/- 0.04	0.16 +/- 0.04	0.01 +/- 0.002
Control	0.53 +/- 0.05	3.98 +/- 0.19	0.36 +/- 0.03	0.55 +/- 0.08	0.32 +/- 0.02	0.21 +/- 0.04	0.15 +/- 0.04	0.01 +/- 0.001
Control (untreated)	0.56 +/- 0.06	3.96 +/- 0.17	0.36 +/- 0.03	0.54 +/- 0.07	0.32 +/- 0.03	0.20 +/- 0.03	0.15 +/- 0.03	0.01 +/-0.001

Relative organ weight (100 g body weight) of female rats (average, n= 8)

Concentration (mg/m3)	Brain	Liver	Kidney	Lung	Heart	Spleen	Thymus	Adrenal
3611	0.54 +/- 0.03	3.89 +/- 0.10	0.38 +/- 0.06	0.57 +/- 0.06	0.34 +/- 0.04	0.19 +/- 0.02	0.17 +/- 0.03	0.01 +/- 0.002
4463	0.53 +/- 0.02	3.86 +/- 0.16	0.37 +/- 0.07	0.57 +/- 0.04	0.32 +/- 0.04	0.21 +/- 0.04	0.16 +/- 0.04	0.01+/- 0.002
5147	0.52 +/- 0.04	3.79 +/- 0.20	0.37 +/- 0.09	0.59 +/- 0.06	0.29 +/- 0.05	0.26 +/- 0.05	0.19 +/- 0.04	0.01 +/- 0.001
Control	0.52 +/- 0.04	3.99 +/- 0.23	0.42 +/- 0.05	0.54 +/- 0.07	0.34 +/- 0.04	0.24 +/- 0.04	0.16 +/- 0.03	0.01 +/- 0.001
Control (untreated)	0.53 +/- 0.04	3.82 +/- 0.19	0.41 +/- 0.03	0.49 +/-0.04	0.32 +/- 0.04	0.23 +/- 0.03	0.15 +/- 0.03	0.01 +/- 0.001

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The inhalation acute toxicity was not determined, because of analitycal problems of the test materials.
The test material is pratically nontoxic according to this results.