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Diss Factsheets

Administrative data

Endpoint:
carcinogenicity
Remarks:
intraperitoneal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
started before 1976, apparently continued until 1987
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Documentation insufficient for assessment: No information on hygiene conditions during preparation of injection suspensions. Fibres treated with HCl of NaOH were far less carcinogenic than their untreated counterparts e.g. chrysotile. Applied doses were put into question 3 years befor this publication, and apparently, the matter was not resolved when the publication was submitted (and this question not resolved in an unpublished presentation a decade later) Inconsistent interpretation of data: It is not possible to exclude carcinogenic effect just from dose of carcinogen.

Data source

Reference
Reference Type:
publication
Title:
Carcinogenicity studies on fibres, metal compounds, and some other dusts in rats.
Author:
Pott F, Ziem U, Reiffer FJ, Huth F, Ernst H, Mohr U
Year:
1987
Bibliographic source:
Experimental Pathology 32(3), 129-152

Materials and methods

Principles of method if other than guideline:
i.p. injection of inorganic material
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Ferrous slags
IUPAC Name:
Ferrous slags
Details on test material:
2 slag wools:
1st slag wool: fibre length 26 µm, diameter 2.6 µ. Slag produced by Rheinstahl in Gelsenkirchen, Germany, presumably mixture of ABS, BOS, and SMS
2nd slag wool: fibre length 14 µm, diameter 1.5 µm. Slag wool produced by Zimmermann, Sprockhövel 2, ABS

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
15 w old females. Pelleted diet and water ad libitum

Administration / exposure

Route of administration:
intraperitoneal
Type of inhalation exposure (if applicable):
other: i.p. 2 mL, 1st injection week 15 of rat life, 2nd injection one week later
Vehicle:
other: 0.9 % w/w NaCl solution in water (saline)
Details on exposure:
dispersion of slag fibres in water by 1-3 min of ultrasonic
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
Not clear: In a presentaion of 1977 the doses of fibres in the experiments are put into question, and in 1987 the matter is apparently not resolved
Duration of treatment / exposure:
2 injections, life-long monitoring
Frequency of treatment:
2x i.p. each 2 ml 0.9 % NaCl with each 20 mg of fibres (it is reported to be 20 µm)
Post exposure period:
life span after 1st treatment (2 slags, if only one number reported: same value for both slags)
20 %: 94 w
50 %: 107-111 w
80 %: 127-129 w
100 %: 165 w
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
analytical conc.
Dertermined by specialist
No. of animals per sex per dose:
1st slag: 99
2nd slag: 96
Control animals:
yes, concurrent vehicle
Positive control:
Chrysotile (not treated): 77.1 - 80.6 % of animals developed tumors

Examinations

Sacrifice and pathology:
animals in bad health were killed
as number of animals the number of animals was counted which died of bad health and those which were sacrificed. Animals lost during anaesthesia or due to cannibalism were not taken into account

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
(Not commented by authors of the study) Treated group 50percentile 107-111 w in comparison to control group 101 w
Mortality:
no mortality observed
Description (incidence):
(Not commented by authors of the study) Treated group 50percentile 107-111 w in comparison to control group 101 w
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not examined
Description (incidence and severity):
no feeding study
Food efficiency:
not examined
Description (incidence and severity):
no feeding study (diet ad libitum)
Water consumption and compound intake (if drinking water study):
not examined
Description (incidence and severity):
no drinking water study
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
no effects observed
Description (incidence and severity):
Tumor incidence: 1st slag wool: 6.1 %, 2nd slag wool 2.1 %. Not significantly different from controls which are in this series of studies 0 % but in similar studies up to some %.
Relevance of carcinogenic effects / potential:
The cancer incidences observed were not different from the controls, and suggest that ferrous slags do not have a carcinogenic potential

Applicant's summary and conclusion

Conclusions:
Ferrous slags are not carcinogenic
Executive summary:

Ferrous slags in the form of two slag wools were tested for their carcinogenic potential by i.p. injection in rats. At week 15, approximately 100 female rats/group were injected fibres in 2 ml 0.9 % w/w saline. A second injection was made 1 week later. The rats were carefully examined after their remaining life span, and the incidence of tumors determined. Animals that died due to cannibalism were not taken into account.

The tumor incidence for saline controls is 0 % and in similar experiments up to 2 %. The tumor incidence for the 1st slag wool is 6.1 %, for the 2nd slag wool 2.1 %. The slag wools tested have no significant carcinogenic effect.