Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study equivalent to OECD guideline 403.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethyl 3-ethoxypropionate (EEP)
- Physical state: liquid
- Analytical purity: 99.8%
- Impurities (identity and concentrations): acetic acid, ethyl propionate and ethyl acrylate as the trace impurities
- Purity test date: no data
- Lot/batch No.: A total of three batches were received for inhalation tests. One batch, identified as SR1D:X-17695-233, was used exclusively for technical development and the LC 50 study (HS&HFL No. 83-0162).

Test animals

Species:
rat
Strain:
other: COBS® CD® (SD)BR
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Mass.
- Age at study initiation: no data
- Weight at study initiation: 230-256 gm
- Fasting period before study: Feed and water were available ad libitum except during the exposure period.
- Housing: 1/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- No data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 20 L glass bell-jar inhalation chambers
- Exposure chamber volume: no data
- Method of holding animals in test chamber: no data
- Source and rate of air: no data
- Method of conditioning air: no data
- System of generating vapours: Vapors were generated by passing air over the surface of the liquid heated to 25 ºC (500 ppm) or 35 ºC (1000 ppm).
- Method of particle size determination: ROYCO: RELATIVE MEASUREMENT OF NON-GASEOUS AIRBORNE MATERIAL (Twice per day).
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: Mean chamber temperatures were 23 ± 0.8, 22 ± 0.2, and 22 ± 0.4 ºC for the 1000, 500 and 0 ppm exposure groups, respectively.


TEST ATMOSPHERE
- COLLECTION: Teflon sample lines conduct chamber atmosphere sample from fixed reference position in 20L chamber to 4- port automated multipositional environmental sampling system (AMESS)

- ANALYSES: MIRAN 1A infrared spectrophotometer equipped with "AMESS" (at least once per hour).



Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
6 h
Remarks on duration:
held for obsevation for a total of 14 days
Concentrations:
target concentrations of 1000, 500 ppm
No. of animals per sex per dose:
Four
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed four times during the study and at termination prior to autopsy.
- Necropsy of survivors performed: Gross pathologic examination of animals was conducted at the termination of the study.
- Other examinations performed: clinical signs: Thorough examinations of animals were conducted at time of weighings.

Animals were exposed in 20 L glass bell-jar inhalation chambers. Vapors were generated by passing air over the surface of the liquid heated to 25 ºC (500 ppm) or 35 ºC (1000 ppm). Chamber atmospheres were quantitatively analyzed at least once per hour by a Mirana® IA infrared analyzer equipped for automated sampling and analysis. In addition, periodic measurements for non-gaseous airborne material were made in each bell-jar using a Royc® five-channel particle analyzer to insure the absence of aerosol. Chamber temperature was monitored at least once per hour. Animals were checked for mortality and moribundity before and after each exposure, and periodic clinical observations were made during exposure. Animals were checked for mortality on weekends.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 998 ppm
Exp. duration:
6 h
Mortality:
There was no mortality during the study.
Clinical signs:
other: Body weight gain was comparable among treated groups and controls. Except for minimal (500 ppm group) to minor (1000 ppm group) lethargy and decreased aural investigatory reflex (both groups) during exposure; no clinical signs of toxicity observed.
Body weight:
Body weight gain was comparable among treated groups and controls.
Gross pathology:
No compound related effects were observed on gross examination of tissues.
Other findings:
Not applicable

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 for Ethyl 3-Ethoxypropionate after 6 hour exposure in rats is > 998 ppm (5967 mg/m3).
Executive summary:

Rats were exposed to vapors of (EEP) to determine the single exposure LC50and effects of repeated exposures over a two-week period. The LC50 following a single six-hour exposure to 481 and 998 ppm was greater than 998 ppm. No mortality was observed. Body weight gain over a 14-day observation period was normal. No significant clinical signs of toxicity were observed. No compound related effects were detected on gross examination of tissues.