Registration Dossier

Administrative data

Endpoint:
chronic toxicity: other route
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. Details on methods / results not available

Data source

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

Materials and methods

Principles of method if other than guideline:
Method employed was essentially that of Boyd 1971 as described in Boyd EM 100-day LD50 index of chronic toxicity Clin Toxicol 4 pp 205-213 1971
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:
not specified
Sex:
male
Details on test animals and environmental conditions:
Not reported

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Details on exposure:
A series of doses were injected ip into groups of 10 male mice, 5 (Monday-Friday) days/week. At the end of each week an apparent LD50 was calculated by Karbers method (Cornfield & Mantael 1950) based upon the generated data. This continued until the apparent LD50 remained constant for 3 consecutive weeks at which point it was assumed that DEP had reached its chronic toxicity value. .
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 w
Frequency of treatment:
daily for 5 (Monday-Friday) days/week.
Doses / concentrations
Remarks:
Doses / Concentrations:
Not reported
No. of animals per sex per dose:
10 males
Details on study design:
Not reported

Examinations

Observations and examinations performed and frequency:
Not reported
Sacrifice and pathology:
Not reported
Other examinations:
Not reported
Statistics:
The LD50, 95% confidence limits & slope were calculated from the 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

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
A cumulative toxicity factor calulated as LD50 acute/chronic LD50 values = 2.87/1.39.

Effect levels

Dose descriptor:
other: LD50
Effect level:
2.87 other: ml/kg
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Previously calculated LD 50. Apparent LD50 at end of week 7 was 1.77 ml/kg, and reached in weeks 12-14, of 1.39.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion