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Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Endpoint:
carcinogenicity
Remarks:
intraperitoneal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Documentation restricted to tumor findigs. Iron(II)Oxide belongs to the iron oxides family and presents comparable physico chemical properties, leading to similar behaviour for the all members of the iron oxide substances. In particular, based on affinity of the chemical structure, Iron Oxide (Fe3O4) and Iron(III)Oxide (Fe2O3) are selected to support read across for the Iron(II)Oxide dossier. Full justification paper is provided in the current Summary Section.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1991

Materials and methods

Principles of method if other than guideline:
Number of animals: 10 m + 10 f per group Two groups of controls were treated with saline or left untreated. Total dose : 600 mg/kg Parameters: Histopathology of adrenals, brain, epididymides, esophagus, eyes, femur, heart, intestines, kidneys, larynx, liver, lung, mammary gland, mesentery, nasopharynx, omentum, ovaries, pancreas, pituitary, prostate, salivary glands, seminal vesicles, skeletal muscle, skin, spinal cord, spleen, sternum, stomach, submaxillary gland, lymph nodes, testes, thymus, thyroid, tongue, trachea, bladder, uterus.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Triiron tetraoxide
EC Number:
215-277-5
EC Name:
Triiron tetraoxide
Cas Number:
1317-61-9
Molecular formula:
Fe3O4
IUPAC Name:
Magnetite
Details on test material:
IUCLID4 Test substance: other TS: Fe3O4 (Bayferrox AC 5100 M)

TS-Freetext:
magnetic iron oxide doped with 2% cobalt

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
physiological saline
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
790 - 914 days
Frequency of treatment:
3 injections of 200 mg/kg; every 8 weeks
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
600 mg/kg total
Basis:

Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
effects observed, treatment-related
Details on results:
Result (carcinogenicity): negative

Effect levels

Dose descriptor:
NOAEL
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Any other information on results incl. tables

RS-Freetext:
Survival: no significant effect
Tumors were detected only in the abdominal cavity:
                   malignant  benign
                     m   f    m  f
Control untreated    2   2    2  1
Control saline       2   1    2  3
treated              0   1    0  0

Applicant's summary and conclusion

Executive summary:

No carcinogenic effect could be demonstrated for Bayferrox AC 5100 M