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EC number: 273-728-1 | CAS number: 69012-28-8 By-product of the manufacture of ferromanganese alloy containing primarily oxides of aluminum, manganese and silicon.
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Table 1: Summary of treatment related findings in the stomach for animals killed after 13 weeks of treatment
Ulceration, Non-glandular Region
Inflammation, Non-glandular Region
Hyperplasia/Hyperkeratosis, Non-glandular Region
Spongiosis, Non-glandular Region
Inflammatory Cell Infiltrate, mucosal/submucosal, Glandular Region
Infiltration, Globule Leukocytes, Glandular Region
No. tissues examined
The systemic toxic potential of the test material when administered for 90 days was investigated in a study conducted in accordance with the standardised guideline OECD 408 under GLP conditions.
The ground, granular test material was administered by gavage to Sprague-Dawley (Crl:CD (SD) rats over a period of 13 weeks. Groups of 10 male and 10 female rats received the test material suspended in corn oil at doses of 10, 100 and 1000 mg/kg/day, with a similarly constituted control group receiving the vehicle (corn oil) only.
Animals were observed daily for mortality and clinical signs. Detailed physical examinations took place weekly, as did measurement of body weight and food consumption. In week 12, animals were subjected to sensory reactivity, grip strength and motor activity investigations as well as ophthalmoscopic examination. Haematology and clinical chemistry parameters were investigated in week 13. Additional blood samples were taken in weeks 7 and 13 to investigate the toxicokinetic of the test material and determine if any absorption took place. Animals were sacrificed at the end of the study by carbon dioxide asphyxiation followed by exsanguination and submitted for necropsy.
Administration of the test material was well tolerated, causing no adverse clinical signs or any changes in the sensory reactivity, grip strength and motor activity assessments and no effect on body weight, food consumption, ophthalmology, haematology, blood chemistry and organ weights.
The plasma samples taken in Week 7 for proof of absorption analysis were analysed (using inductively coupled plasma with ICP-MS detection) and manganese, aluminium, barium and silicon concentrations were found to less than the limit of quantification (0.0025, 0.025, 0.0125 and 5 mg/L, respectively) in all groups indicating that no quantifiable absorption had occurred.
The only findings in this study occurred in the stomach. The macroscopic examination revealed the presence of mucosal depressions in one female given 100 mg/kg/day and in one male given 1000 mg/kg/day. At the histopathological examination there were findings in the glandular and non-glandular stomach of one female given 100 mg/kg/day and four males given 1000 mg/kg/day. The findings comprised ulceration with inflammation and oedema in the non-glandular region and foveolar hyperplasia associated with eosinophilic globules and inflammatory cell infiltrate in the glandular region. In one of the males the inflammatory changes were associated with infiltration of globule leukocytes.
In this study these changes were attributed to the physical properties of the test material, rather than a consequence of a systemic toxic response. The test material was a hard, granular material which was considered to have caused physical irritation leading to localised damage to the gastric mucosa in a few animals.
It was concluded that oral (gavage) administration of the granulated test material to Sprague-Dawley rats at doses up to 1000 mg/kg/day for 13 weeks did not cause any evidence of systemic toxicity. The no-observed-adverse-effect level (NOAEL) for systemic toxicity in this study was considered to be 1000 mg/kg/day.
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