Calcium lignosulphonate: Re-evaluation of relevant endpoints to re-confirm validity and NOAEL of a 90-day feeding study in rats

Thiel, Anette; Braun, William A.; Cary, Maurice; Engelhardt, Jeffery A.; Goodman, Dawn G.; Hall, William C.; Romeike, Annette; Ward, Jerrold M.

doi:10.1016/j.yrtph.2013.04.007

Cited by 7 publications

(7 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Additional evaluation of the clinical pathology data and evaluation of the animal health certificates from the regular screening programme of the performing laboratory was also done. The conclusions were published together with other study results by Thiel et al (2013).…”

Section: • Acute Toxicitysupporting

confidence: 56%

“…• Absorption, distribution, metabolism and elimination • Subacute, subchronic and chronic toxicity studies A 90-day feeding study in Wistar rats (Thiel et al, 2007), where calcium lignosulphonate (40-65, purity: 95.5%) was administered at doses of 0, 500, 1,000 and 2,000 mg/kg bw per day, was evaluated by the EFSA ANS Panel (2010,2011). It considered that the study to be inadequate due to the potentially impaired health status of the animals based upon a high incidence of minimal lymphoid hyperplasia in mesenteric/mandibular lymph nodes and Peyer's patches, and minimal lymphoid cell infiltration in the liver in all animals.…”

Section: Toxicological Profilementioning

confidence: 99%

See 1 more Smart Citation

Scientific opinion on the evaluation of substances as acceptable previous cargoes for edible fats and oils

Knutsen¹,

Alexander²,

Barregård³

et al. 2017

EFS2

View full text Add to dashboard Cite

Shipping of edible fats and oils into Europe is permitted in bulk tanks, provided that the previous cargo is included in a positive list. The European Commission requested EFSA to evaluate the acceptability as previous cargoes for fats and oils the substances calcium lignosulphonate, methyl acetate, ethyl tertbutyl ether (ETBE) and ammonium sulphate. The evaluation was based on the same criteria as those used for the evaluation of the substances currently on the list in the Annex to Commission Directive 96/ 3/EC as acceptable previous cargoes for edible fats and oils. Methyl acetate and ETBE meet the criteria for acceptability as previous cargoes. Due to uncertainties, mainly with regard to the composition and toxicity of the low molecular mass fraction, and the fact that the toxicological database is limited to the 40-65 grade and does not cover all grades of calcium lignosulphonate shipped as previous cargoes, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) concluded that calcium lignosulphonate does not meet the criteria for acceptability as a previous cargo. Only food-grade ammonium sulphate meets the criteria for acceptability as a previous cargo due to uncertainties about impurities in other (non-food) grades.

show abstract

Section: • Acute Toxicitysupporting

confidence: 56%

Section: Toxicological Profilementioning

confidence: 99%

Scientific opinion on the evaluation of substances as acceptable previous cargoes for edible fats and oils

Knutsen¹,

Alexander²,

Barregård³

et al. 2017

EFS2

View full text Add to dashboard Cite

show abstract

“…There is no evidence from these subchronic studies, and from chronic studies with medium-and high-viscosity white mineral oils (P70A/H, P70H, P100H) (Shoda et al 1997;Trimmer et al 2004), that the MLN microgranulomas in F-344 rats progress to more a severe pathology such as inflammatory, necrotic or fibrotic lesions (Carlton et al 2001;EFSA 2012;JECFA 2012). This is supported by findings of histiocytosis in MLNs of rats orally exposed to other high molecular weight, poorly soluble materials such as calcium lignosulfonate (Thiel et al 2013), pentosan polysulphate (Abdo et al 2003), and copovidone (Mellert et al 2004). The presence of foamy histiocytes in MLNs indicate concentration-dependent (overloaded) MOSH-lipid-laden, metabolically activated macrophages which, according to the Joint FAO/WHO Expert Committee on Food Additives (JECFA 2012), do not represent an adverse effect as such.…”

Section: Effects Associated With the Accumulation Of Mosh In Animal Tmentioning

confidence: 76%

Mineral oil in food, cosmetic products, and in products regulated by other legislations

Pirow

Blume

Hellwig

et al. 2019

Critical Reviews in Toxicology

View full text Add to dashboard Cite

For a few years, mineral oils and their potential adverse health effects have been a constant issue of concern in many regulatory areas such as food, cosmetics, other consumer products, and industrial chemicals. Analytically, two fractions can be distinguished: mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH). This paper aims at assessing the bioaccumulative potential and associated histopathological effects of MOSH as well as the carcinogenic potential of MOAH for consumer-relevant mineral oils. It also covers the absorption, distribution, metabolism, and excretion of MOSH and MOAH upon oral and dermal exposures. The use and occurrence of consumerrelevant, highly refined mineral oils in food, cosmetics and medicinal products are summarized, and estimates for the exposure of consumers are provided. Also addressed are the challenges in characterizing the substance identity of mineral oil products under REACH. Evidence from more recent autopsy and biopsy studies, along with information on decreasing food contamination levels, indicates a low risk for adverse hepatic lesions that may arise from the retention of MOSH in the liver. With respect to MOAH, at present there is no indication of any carcinogenic effects in animals dermally or orally exposed to highly refined mineral oils and waxes. Such products are used not only in cosmetics but also in medicinal products and as additives in food contact materials. The safety of these mineral oilcontaining products is thus indirectly documented by their prevalent and long-term use, with a simultaneous lack of clinical and epidemiological evidence for adverse health effects.

show abstract

“…Therefore, the presence of substantial amount of this compound in the tissues is unlikely [11]. Furthermore, the JECFA set an acceptable daily intake of calcium lignosulfonate, based on a 90-day rat study, at a dosage up to 2,000 mg/kg body weight [19, 42]. Accordingly, such amount of calcium lignosulfonate given to rats in AXH+AFB 1 group is not possible to cause hepatotoxic.…”

Section: Discussionmentioning

confidence: 99%

The effects of astaxanthin on liver histopathology and expression of superoxide dismutase in rat aflatoxicosis

Monmeesil

Fungfuang

Tulayakul

et al. 2019

The Journal of Veterinary Medical Science

View full text Add to dashboard Cite

The metabolism of aflatoxin B 1 (AFB 1 ) generates reactive oxygen species (ROS) that destroys hepatocytes. Meanwhile, astaxanthin (AX) is known to have stronger antioxidative activity than other carotenoids. This study aimed to investigate hepatoprotective role of AX from AFB 1 -induced toxicity in rat by histopathological study and immunohistochemistry of Cu/Zn-SOD (SOD1) which acts as the first enzyme in antioxidative reaction against cell injury from ROS. Twenty Wistar rats were randomly divided into 4 groups. The control and AFB 1 groups were gavaged by water for 7 days followed by a single DMSO and 1 mg/kg AFB 1 , respectively. The AXL+ AFB 1 and AXH+ AFB 1 groups were given of 5 mg/kg and 100 mg/kg AX for 7 days before 1 mg/kg AFB 1 administration. The result showed significantly elevated liver weight per 100 g body weight in AFB 1 group. The histopathological finding revealed vacuolar degeneration, necrosis, megalocytosis and binucleation of hepatocytes with bile duct hyperplasia in AFB 1 group. The severities of pathological changes were sequentially reduced in AXL+AFB 1 and AXH+AFB 1 groups. Most rats in AXH+AFB 1 group owned hypertrophic hepatocytes and atypical proliferation of cholangiocytes which are adaptive responses to severe hepatocyte damage. The SOD1 expression was also significantly higher in AXH+AFB 1 group than solely treated AFB 1 and AXL+AFB 1 groups. In conclusion, AX alleviated AFB 1 -induced liver damage in rat by stimulating SOD1 expression and transdifferentiation of cholangiocytes in dose dependent manner.

show abstract

Calcium lignosulphonate: Re-evaluation of relevant endpoints to re-confirm validity and NOAEL of a 90-day feeding study in rats

Cited by 7 publications

References 18 publications

Scientific opinion on the evaluation of substances as acceptable previous cargoes for edible fats and oils

Scientific opinion on the evaluation of substances as acceptable previous cargoes for edible fats and oils

Mineral oil in food, cosmetic products, and in products regulated by other legislations

The effects of astaxanthin on liver histopathology and expression of superoxide dismutase in rat aflatoxicosis

Contact Info

Product

Resources

About