SILICA

No increase in mutation frequencies were seen in the Salmonella TA-1530 or G-46 assay and no significant increase in recombinant activity in the Saccharomyces D3 assay treated with Calcium Silicate.2 A subacute dose of 150 mg/kg of Calcium Silicate produced 3% breaks in bone marrow cells arrested in c-metaphase. In a metaphase spread of bone marrow cells, Calcium Silicate produced no significant increase in the number of aberrations compared to controls and in a dominant lethal assay did not induce any dominant lethal mutations. In the S. typhimurium LT2 spot test (TA98, TA100, TA1535, TA1537, and TA1538) with or without metabolic activation, Magnesium Aluminum Silicate and Hectorite were found to be nonmutagenic. In primary hepatocyte cultures, the addition of Attapulgite at 10 µg/cm2 caused significant increases in UDS in rat pleural mesothelial cells. Zeolite particles (< 10 µm) produced statistically significant increase in the percentage of aberrant metaphases, mostly chromatid breaks. Sodium Metasilicate was nonmutagenic in a DNA damage and repair assay without metabolic activiation using B. subtilis.3 Sodium Silicate was nonmutagenic in studies using E. coli strains B/Sd-4/1,3,4,5 and B/Sd-4/3,4. Genotoxicity data are summarized in Table 8. Aluminum Silicate, Hydrated Silica, Silica, Sodium Metasilicate, Sodium Silicate, and Zinc Silicate were not genotoxic in Ames tests, HPRT gene mutation assays, or chromosome aberration tests.8,11-13,16,20,28,93-96 Potential genotoxicity was observed in Montmorillonite in an Ames test and a cytokinesis block micronucleus cytome assay.97,98 Genotoxicity studies of Hydrated Silica at up to 5000 mg/kg in mice and rats were negative.20 Mutagenic Inhibition Aluminum Calcium Sodium Silicate In a study of mutagenic inhibition, aflatoxin (2.5 mg/kg) was incorporated into rat feed with Aluminum Calcium … [kırpıldı - bölüm toplam 2460 karakter]

A 4% solution of Magnesium Aluminum Silicate and a 4% solution of Sodium Magnesium Silicate caused minimal eye irritation in a Draize eye irritation test.2 Bentonite caused severe iritis after injection into the anterior chamber of the eyes of rabbits. When injected intralamellarly, widespread corneal infiltrates and retrocorneal membranes were recorded. In a primary eye irritation study in rabbits, Hectorite was moderately irritating without washing and practically nonirritating to the eye with a washout. Rats tolerated a single dose of Zeolite without any adverse reaction to the eye. Potassium Silicate was nonirritating in two acute eye irritation studies in rabbits.3 Sodium Metasilicate (42.4% water) was corrosive to the rabbit eye. Sodium Silicate was a severe eye irritant in acute eye irritation studies. A skin freshener (10% of a 40% aqueous solution) containing Sodium Silicate was nonirritating. Sodium Silicate in another three Draize eye irritation studies was highly irritating, irritating, and nonirritating, respectively. In vitro and animal ocular irritation data are summarized in Table 10. Aluminum Silicate (tested pure) was predicted to be not irritating using the hen's egg test chorioallantoic membrane (HET-CAM) method.13 Sodium Metasilicate (concentration not reported) was predicted to be corrosive in an in vitro method using rabbit eyes, and Zinc Silicate (20%) was predicted to be irritating in a bovine corneal opacity and permeability (BCOP) test.8,11 Potassium Silicate was not irritating to slightly irritating when tested at up to 35% in rabbit eyes.10,15 Hydrated Silica (concentration not provided) and Silica were not irritating to slight irritating in rabbit eyes.20,28,69,70

Silica and Hydrated Silica The effects of orally administered Silica and Hydrated Silica (as 1250 mg of Silica in apple juice) to 2 groups of 6 volunteers (5 males and female in each group).16 The solutions were consumed in 2 doses, morning and midday on the same day. The total urine was collected daily and analyzed. During the 4 days post-treatment, changes of renal Silica secretion were not observed. Daily Silica increments in urine after ingestion ranged between 7 and 23 mg. For Silica, the individual baseline values of the pre-test phase were very variable and individually different; mean excretion rates ranged from 25 to 87 mg/day. In the post-treatment phase, individual mean excretion rates ranged from 32 to 61 mg/day. For Hydrated Silica, the individual baseline values of the pre-test phase were very variable and individually different; mean excretion rates ranged from 16 to 71 mg/day. In the post-treatment phase, individual mean excretion rates ranged from 20 to 81 mg/day. Overall, increases in excretion were not unequivocally detectable. The authors noted that the small apparent increases were in marked contrast to the high dose of 2500 mg Silica applied.  Distributed for comment only -- do not cite or quote Case Reports Colloidal Sodium Metasilicate was fatal to one man and neutralized Sodium Silicate produced vomiting, diarrhea, and gastrointestinal bleeding in another man in separate case reports of oral ingestion.3 Sodium Metasilicate Acute kidney injury was reported in a 52-year-old man who had ingested approximately 150 ml of a plate developer solution containing Sodium Metasilicate.106 The patient also developed severe upper airway obstruction due to laryngeal edema, severe inflammation of the upper gastrointestinal tract with narrowing of the esophagus and pyloric region. The … [kırpıldı - bölüm toplam 9903 karakter]

Magnesium Aluminum Silicate (4%) was a weak primary skin irritant in rabbits and had no cumulative skin irritation in guinea pigs.2 No gross effects were reported in any of these studies. Sodium Magnesium Silicate (4%) had no primary skin irritation in rabbits and had no cumulative skin irritation in guinea pigs. Hectorite was nonirritating to the skin of rabbits in a Draize primary skin irritation study. Applications of 2 g of Magnesium Aluminum Silicate made to the skin of two humans daily for 1 week caused no effects. Dermal irritation of Potassium Silicate, Sodium Metasilicate, and Sodium Silicate ranged from negligible to severe, depending on the species tested and the molar ratio and concentration tested.3 Sodium Metasilicate/carbonate detergent (37% Sodium Metasilicate) mixed 50/50 with water was considered a severe skin irritant when tested on intact and abraded human skin. Detergents containing 7%, 13%, and 6% Sodium Silicate mixed 50/50 with water, however, were negligible skin irritants to intact and abraded human skin. Sodium Silicate (10% of a 40% aqueous solution) was negative in a repeat-insult predictive patch test in humans. The same aqueous solution of Sodium Silicate was considered mild under normal use conditions in a study of cumulative irritant properties. Sodium Metasilicate and Sodium Silicate were studied in modified soap chamber tests. No burning or itching was observed and low erythema + edema scores were noted. Sodium Metasilicate and Sodium Silicate, tested in elbow crease studies and semioccluded patch tests, produced low grade and transient irritation. Sodium Metasilicate was negative in the local lymph node assay (LLNA), but a delayed-type hypersensitivity response was observed in mice.3 In vitro and animal dermal irritation and animal sensitization data are summarized in Table 9. Aluminum Silicate … [kırpıldı - bölüm toplam 2686 karakter]

The International Agency for Research on Cancer (IARC) has ruled Attapulgite fibers > 5µm as group 2B, possibly carcinogenic to humans, and fibers < 5µm as group 3, not classified as to their carcinogenicity to humans.99  Distributed for comment only -- do not cite or quote The natural Zeolites (clinoptilolite, phillipsite, mordenite, and nonfibrous Japanese zeolite) and synthetic Zeolites cannot be classified as to their carcinogenicity to humans (group 3) according to IARC. Silica IARC concluded that amorphous Silica is not classifiable as to its carcinogenicity to humans based on inadequate evidence in humans and inadequate evidence of increased tumors in animals.99 Oral Hydrated Silica In a carcinogenicity study, groups of 10 male and 10 female B 6 C 3 F 1 mice received Hydrated Silica in their feed.84 In the female mice, the frequency of adenocarcinoma in the lungs was 1/16 (6.25%) for the control group and 1/19 (5.3%), 0/20 (0%), and 1/20 (5%) for the low, mid and high dose groups. In the males, the frequency of adenocarcinoma in the lungs was 1/16 (6.25%) for the control and 2/17 (11.8%), 3/14 (21.4%), and 3/16 (18.8%) for the low, mid, and high dose groups. There was low correlation of hyperplastic nodules/hepatocellular carcinoma/hemangioma/fibrosarcoma in the treatment groups compared to the controls. The authors concluded that the non-neoplastic lesions were of no toxicological significance. Silica In a 2-year dietary study, Wistar rats (n = 40; 20 males and 20 females) received 100 mg/kg Silica (pyrogenic) in their feed.28 The rats were weighed before and after treatment. At the end of the treatment period, the rats were killed and necropsied. There were no clinical signs of toxicity observed during the treatment period. The rates of tumors observed in the treated rats were comparable to historical controls. The authors concluded that there were no carcinogenic effects from … [kırpıldı - bölüm toplam 5161 karakter]

IARC Grup 3 - Kanserojenliği sınıflandırılamıyor. The available evidence is insufficient for a classification. This does NOT mean 'safe'; it means 'not enough data'. (Monograph volume: Sup 7, 68). Sınır: IARC TEHLİKE sınıflandırması yapar, RİSK değil - 'bir koşulda kansere yol açabilir' der, 'kozmetikteki kullanım seviyesinde kanser yapar' DEMEZ. Maruziyet yolu ve dozu ayrıca değerlendirilmelidir. Data is a 01/2021 snapshot.

EPA ToxValDB skin/eye data - endpoint: skin irritation: in vivo, classification: Studies Indicate No Significant Irritation, species: rabbit, study: skin irritation, guideline: OECD Guideline 404 (Acute Dermal Irritation / Corrosion) according to, year: 1991. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data - endpoint: eye irritation: in vivo, classification: Studies Indicate No Significant Irritation, species: rabbit, study: eye irritation, guideline: no guideline available other guideline: Draize-Test equivalent or similar to, year: 1975. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data - endpoint: Skin Sensitization, classification: Classification not possible. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data - endpoint: Skin Irritation, classification: Not classified. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data - endpoint: Eye Irritation, classification: Category 2. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.