Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: RELIABLE SUMMARY STUDY.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
IUCLID DATASET SUBSTANCE ID:68512-62-9
Author:
EUROPEAN CHEMICALS BUREAU
Year:
2000
Bibliographic source:
IUCLID DATASET SUBSTANCE ID:68512-62-9 PG 73

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
procedure as detailed in paper by Feuston M.H.
Developmental toxicity of clarified slurry oil applied dermally to rats, Toxicol. Ind. Health,vol. 5, p. 587, 1989.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
dermal
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
19 days
Doses / concentrations
Remarks:
Doses / Concentrations:
five tests groups:4, 8, 30, 125 and 250 mg/kg/day.
Basis:
no data
No. of animals per sex per dose:
10
Control animals:
yes, concurrent no treatment

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
ca. 4 mg/kg bw/day
Based on:
no data
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
ca. 4 mg/kg bw/day
Based on:
no data
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

SIGNS OF MATERNAL TOXICITY, seen at doses as low as 8 mg/kg/day, included VAGINAL BLEEDING, DECREASED BODYWEIGHT GAIN, REDUCED FOOD CONSUMPTION, DEATH, INCREASED RELATIVE LIVER WEIGHTS, ATROPHY OF THE THYMUS, and ABERRANT SERUM CHEMISTRY. The number of FOETAL RESORPTIONS/DEATHS was MARKEDLY INCREASED, and the number of VIABLE OFFSPRING DECREASED, by CCCO exposure at doses of 30 mg/kg/day and greater. THE GROUP RECEIVING 250 mg/kg/day CARRIED NO VIABLE OFFSPRING. Foetuses from pregnant females exposed to CCCO at doses greater than 8 mg/kg/day were smaller than those from the negative control and 4 mg/kg/day groups, and their skeletons showed decreased ossification. ABNORMAL EXTERNAL DEVELOPMENT and VISCERAL DEVELOPMENT WERE OBSERVED IN LIVING AND DEAD FOETUSES EXPOSED IN UTERO to CCCO at DOSE LEVELS of 8 mg/kg/day and greater.

Applicant's summary and conclusion