Registration Dossier

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: see 'Remark'
Remarks:
Hazardous Substances Data Bank (HSDB®) is a toxicology data file on the National Library of Medicine's (NLM) Toxicology Data Network (TOXNET®). It focuses on the toxicology of potentially hazardous chemicals. It is enhanced with information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, nanomaterials, and related areas. All data are referenced and derived from a core set of books, government documents, technical reports and selected primary journal literature. HSDB is peer-reviewed by the Scientific Review Panel (SRP), a committee of experts in the major subject areas within the data bank's scope. HSDB is organized into individual chemical records, and contains over 5000 such records. This study was performed before the introduction of OECD guidelines and GLP. Limited details available on methodology.

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
EPA HPV Challenge Program's Robust Summaries and Test Plans
Author:
HSDB - http://toxnet.nlm.nih.gov/
Year:
2008
Bibliographic source:
Available from the Database Query page at: http://www.epa.gov/hpv/pubs/hpvrstp.htm on Phthalate Esters Category, Diethyl phthalate (84-66-2) p. 23 (2007) as of April 28, 2008. **PEER REVIEWED**
Reference Type:
other company data
Title:
Unnamed
Year:
2006

Materials and methods

Principles of method if other than guideline:
To determine the effects, in rats, of acute inhalation exposure
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole body inhalation chamber
- 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 particulates/aerosols: Air was bubbled through diethyl phthalate at 150 deg C
- Method of particle size determination: No data
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: No data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
Concentrations:
511 ppm (4.64 mg/L)
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
Statistics:
Not applicable

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LC50
Effect level:
>= 511 ppm
Exp. duration:
6 h
Sex:
not specified
Dose descriptor:
LC50
Effect level:
>= 4.64 mg/L air (nominal)
Exp. duration:
6 h

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions in which this study was conducted LD50 was >511 ppm when administered by the inhalation route for 6 hours.
Executive summary:

Under the conditions in which this study was conducted, no mortality occurred when rats were exposed to a saturated vapour of 511 ppm (4.64 mg/L) by the inhalation route for 6 hours.