Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 403 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

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

Constituent 1
Chemical structure
Reference substance name:
2,3-epoxypropyl o-tolyl ether
EC Number:
218-645-3
EC Name:
2,3-epoxypropyl o-tolyl ether
Cas Number:
2210-79-9
Molecular formula:
C10H12O2
IUPAC Name:
2-[(2-methylphenoxy)methyl]oxirane
Constituent 2
Reference substance name:
Oxirane, 2-[(2-methylphenoxy)methyl]-
IUPAC Name:
Oxirane, 2-[(2-methylphenoxy)methyl]-
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
Male and female Fischer 344 rats, approximately six weeks of age, were obtained as stock animals from Charles River Breeding Laboratories, Inc., Kingston, NY. The animals were housed two per cage in stainless steel wire cages and acclimated to the laboratory for at least one week prior to exposure. material. Prior to the exposure and during the two-week post-exposure period, the animals were housed in a room designed to maintain adequate environmental conditions concerning temperature and relative humidity as per the O.E.C.D. test guideline. A 12-hour photoperiod was employed throughout the study. Animals were fed Purina Certified Rodent Chow #5002 (Purina Mills Inc., St. Louis, MO) and water ad libitum except during exposure.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
clean air
Details on inhalation exposure:
Exposure was conducted in one cubic meter, stainless steel and glass Rochester-type inhalation chamber [90 centimeter (cm) wide by 90 cm high by 90 cm deep with a pyramidal top and bottom] under dynamic airflow conditions. Chamber airflow was maintained at 225 liters per minute which was sufficient to provide 12-15 air changes per hour.

Vapors of the test substance were generated using the glass J-tube method of Miller et al., (1980). Liquid test material was pumped into the J-tube to coat the glass beads; clean compressed air was passed through the J-tube simultaneously to volatilize the test substancel. The air was heated with a heat gun (FHT-4, Master Appliance Corporation, Racine, WI) to 42°C to vaporize the test substance

The vapor concentration of the test substance was determined four times during the exposure by adsorption onto Chromosorb 102 sampling tubes (SKC, Inc., Eighty Four, PA). The tubes were desorbed in carbon disulfide/acetone, and the extracts analyzed with a capillary column HP 5890 gas chromatograph (Hewlett Packard Co., Avondale, PA) that was calibrated with the test substance in CS2.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
6.1 ppm (40.9 mg/m3) maximum achievable.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The animals were singly housed and whole-body exposed to test substance vapors in one cubic meter, stainless steel and glass Rochester-type inhalation chamber for four hr. Animals were weighed and examined prior to exposure to the test material. Animals were observed during the exposure period and daily during the two-week post-exposure period. All surviving rats were weighed on Days 2,4,8, 11, and 15 during the two- week post-exposure period. All rats were submitted for a complete necropsy examination on Day 15, anesthetized with methoxyflurane and euthanatized.
Statistics:
Means and standard deviations of animal body weights, chamber temperatures, relative humidity, airflow and chamber concentration (means only) were calculated for descriptive purposes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6.1 ppm
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None
Clinical signs:
other: None
Body weight:
Normal body weight gain
Gross pathology:
None related top exposure

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance was non-toxic to rats when exposed to the maxium achievable vapor concentration of 6.1 ppm for four hours.
Executive summary:

The test substance, 2,3 -epoxypropyl o-tolyl ether was accessed for acute inhalation toxicity to rats in an O.E.C.D. test guideline no. 403 study by whole-body exposure for four hours.The test substance was non-toxic to rats when exposed to the maxium achievable vapor concentration of 6.1 ppm for four hours. Therefore, the LC50 value for the test substance is > 6.1 ppm.