Fatty acids, C18 unsaturated, ethyl & methyl esters

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions (purity: 76%)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18 unsaturated, ethyl & methyl esters

EC Number:

941-981-3

Molecular formula:

not available, substance is UVCB

IUPAC Name:

Fatty acids, C18 unsaturated, ethyl & methyl esters

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, Pennsylvania, USA
- Age at study initiation: 10 - 11 weeks old
- Weight at study initiation: 325 - 341 g (males), 203 - 243 g (females)
- Housing: individually housed in suspended stainless steel caging with mesh floors
- Diet: Purina Rodent Chow #5012, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 22
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: rectangular whole body Plexiglas chamber
- Exposure chamber volume: 150 L
- Source and rate of air: air compressor (JUN-AIR), approximately 25.1 L/min filtered air
- System of generating particulates/aerosols: The test atmosphere was generated using a l/4 inch JCO atomizer, FC4 fluid cap and AC 1502 air cap (Spraying Systems Inc.). Compressed air was supplied at 30 psi. The test substance was metered to the atomisation nozzle through Size 14 Master Flex Tygon tubing, using a Master Flex Pump Model 7520-35.
- Temperature, humidity in air chamber: 19-21°C, 37-65%

TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric samples were withdrawn at 6 intervals from the breathing zone of the animals. Samples were collected using 25 mm glass fiber filters (GF/B Whatman) in a filter holder attached by 1/4 inch tygon tubing to a Reliance Electric vacuum pump Model #G557X. Filter papers were weighed before and after collection to determine the mass collected. This value was divided by the total volume of air sampled to determine the chamber concentration. The collections were carried out for 3 minutes at airflows of 4 L/min. Sample airflows were measured using an Omega Flowmeter Model #FMA 5610.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE
- Particle size distribution: An eight-stage Andersen cascade impactor was used to assess the particle size distribution of the test atmosphere. Samples were withdrawn from the breathing zone of the animals at two intervals. The filter paper collection stages were weighed before and after sampling to determine the mass collected upon each stage.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The aerodynamic mass median diameter and geometric standard deviation were determined graphically using two-cycle logarithmic probit axes.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetrically

Duration of exposure:

4 h

Remarks on duration:

(also 15 min)

Concentrations:

The gravimetric and nominal chamber concentrations were 2.02 and 13.37 mg/L, respectively.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality, signs of gross toxicity, and behavioral changes were observed prior to exposure, at least every 30 min during exposure, upon removal from the exposure chamber and at least once daily thereafter for 14 days.
- Necropsy of survivors performed: yes (tissues and organs of the thoracic and abdominal cavities were examined)

Results and discussion

Preliminary study:

Prior to initiation of the full inhalation study, pre-test trials were conducted to establish generation procedures to achieve, to the extent possible, the desired chamber concentration (2.0 mg/L) and desired particle size distribution (mass median aerodynamic diameter less than or equal to 4 μm). The exposure procedures and atomisation equipment used were based on the results of pre-test trial which provided a gravimetric concentration of 2.11 mg/L and a mass median aerodynamic diameter of 3.1 μm.

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.02 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occurred.

Clinical signs:

other: In-chamber animal observations included ocular and nasal discharge, hunched posture and hypoactivity. Upon removal from the exposure chamber, all animals recovered from the above symptoms and appeared active and healthy for the 14-day observation period.

Body weight:

All animals gained weight over the 14-day observation period.

Gross pathology:

No gross abnormalities were noted.

Any other information on results incl. tables

Table 1: Summary of particle size distribution

Sample No.	Time of Sample (hours)	Collection Time (minutes)	Mass Median Aerodynamic Diameter (µm)	Geometric Standard Deviation
1	1.5	2	3.0	1.87
2	3	2	3.0	1.78

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified