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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
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

Constituent 1
Reference substance name:
Clarified oils (petroleum), catalytic cracked
EC Number:
265-064-6
EC Name:
Clarified oils (petroleum), catalytic cracked
Cas Number:
64741-62-4
IUPAC Name:
64741-62-4

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