Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: A review presented at the Society of Toxicology's 13th annual meeting Washington DC USA 1974 before the introduction of OECD guidelines and GLP

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1975

Materials and methods

Principles of method if other than guideline:
A review paper presented more than 30 years ago with limited details of methodology and before the introduction of OECD guidelines & GLP.
Groups of 10 male ICR mice received undiluted DEP via the intraperitoneal route and were then observed for 7 days.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Supplied by Eastman Chemicals Kingsport Tennessee USA

Test animals

Species:
mouse
Strain:
ICR
Sex:
male
Details on test animals and environmental conditions:
None

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
unchanged (no vehicle)
Details on exposure:
Single ip dose
Doses:
Not reported
No. of animals per sex per dose:
10 males
Control animals:
not specified
Details on study design:
No details
Statistics:
The LD50, 95% confidence limits & slope were calculated from the 7 day mortality data by Cornfield and Mantel's (1950) modification of Karber's method as described in Some new aspects of the application of maximum liklihoodto the calculation of the dosage response curve. Amer Statist Assoc J 45, pp 181-210 1950

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3.22 other: g/kg bw
Based on:
test mat.
95% CL:
> 2.86 - < 3.62
Sex:
male
Dose descriptor:
LD50
Effect level:
2.87 mL/kg bw
Based on:
test mat.
Mortality:
Not reported
Clinical signs:
Not reported
Body weight:
Not reported
Gross pathology:
Not reported
Other findings:
Not reported

Any other information on results incl. tables

The LD50 value (3.22 g/kg) compares well with values obtained by other investigators, Calley et al (2.83 g/kg) & Fassett (2.8 g/kg).

Calley D, Autian J & Guess WL Toxicology of a series of phthalate esters. J Pharm Sci 55 pp 158 -162 1966

Fassett DW, Esters in Industrial Hygeine and Toxicology, Patty FA editor Vol 2 pp 1902 -1910 1963

Applicant's summary and conclusion