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Description of key information

No experimental data on sodium acrylate are available. Data on the structural analogue acrylic acid which has been extensively studied, are included for assessment. In a subchronic study with Fischer 344 rats following administration of acrylic acid in the drinking water for 90 days, the NOAEL was determined to be 83 mg/kg bw. Taking into account the molecular weights of both substances, this corresponds to a NOAEL of 108 mg/kg bw for sodium acrylate in rats.

Key value for chemical safety assessment

Additional information

No experimental data on sodium acrylate are available. Data on the structural analogue acrylic acid which has been extensively studied, are included for assessment.

Repeated dose toxicity: Oral administration

 

 

Wistar rats which received acrylic acid in the drinking water at doses of 120, 800, 2000 or 5000 ppm (corresponding to approx. 6, 40, 100 or 200 mg/kg bw/d in males, and 10, 66, 150 or 375 mg/kg bw/d in females) for 3 months (10 rats/group/sex) and 12 months (20 rats/group/sex) showed reduced water consumption at 2000 ppm and 5000 ppm dosages (BASF AG, 1987; Hellwig et al., 1993). No treatment-related premature deaths occurred. Lower food consumption was seen in high dose males and reduced body weight gain was observed in males from 2000 ppm and 5000 ppm groups. No treatment-related effects on haematology, clinical chemistry, and urine parameters were found. No substance-related toxic effect could be microscopically demonstrated in a comprehensive list of organs examined in the two high doses. Obviously due to the bad palatability treated animals had lower drinking water uptake, which was considered to result in lower food consumption and body weight gain. Mortality and toxic effects in the kidney and the stomach found in the gavage study were not confirmed in this study at comparable doses indicating that these effects were attributable to high local and blood peak values after bolus administration by gavage.

Based on the reduced body weight gain in males and lower water consumption in both sexes, the NOAEL of this study was considered to be 800 ppm in male rats (corresponding to 40 mg/kg bw). In females the NOAEL was considered to be 5000 ppm (corresponding to 375 mg/kg bw) since reduced water consumption was not interpreted as a clear adverse health effect.

 

 

Fischer 344 rats (15 animals/sex/group) in another 90-day drinking water study (Inter-Company Acrylate Study Group, 1980; DePass et al., 1983) were administered doses of 83, 250, or 750 mg/kg bw/d of acrylic acid. No deaths occurred during the treatment period. However, clear dose-related effects were observed. At the high-dose level there was reduced food and water consumption, reduced body weight gain, lower organ weights of liver, kidneys, spleen, heart, brain, and elevated testes weight and some altered clinical chemistry parameters (increased levels of serum urea nitrogen, glucose, alkaline phosphatase and aspartate transaminase). Furthermore, there was a statistically significant decrease in total serum cholesterol noted for the high level females. In both sexes increases of urinary protein and specific gravity and a decrease in urinary pH values were noted. No significant prevalence of microscopic lesions was found in any of the animals. At 250 mg/kg bw, a decrease in water consumption was noted for both sexes. Body weight gain was lower in females. Kidney weights were increased in both sexes and relative testes weights were increased in males. Effects on serum urea nitrogen, cholesterol and alkaline phosphatase in female rats and urinary specific gravity and protein in both sexes were similar, but less pronounced than those observed at the high dose level.

At 83 mg/kg bw the only effects noted were a reduction of water consumption by male rats and a slight increase in red blood cells in female rats. Both findings were not considered to be of toxicological relevance, therefore 83 mg/kg bw was the NOAEL of this study.

 

In an oral 90-day study (BASF AG, 1987; Hellwig et al., 1993) acrylic acid (purity: approx. 99 %) was administered by gavage in two dosages (150 and 375 mg/kg bw/d) to Wistar rats. Toxicological findings reported in this study were mainly related to local irritating and corrosive effects of acrylic acid at the port of entry due to gavage administration. Since sodium acrylate does not possess any irritating properties, this study was disregarded for the hazard assessment of the acrylic salt.

 

Conclusions

 

The NOAEL for sodium acrylate was derived conservatively from the NOAEL = 83 mg/kg bw based on organ weight changes, abnormal clinical chemistry and urine analysis parameters evident in the 90-day drinking water study in Fisher 344 rats (Inter-Company Acrylate Study Group, 1980; DePass et al., 1983). Taking into account the higher molecular weight of sodium acrylate (94.0445 g/mol) as compared to acrylic acid (72.06 g/mol), this corresponds to a NOAEL = 108 mg/kg bw.

Justification for classification or non-classification

EU classification according to Annex VI of Directive 67/548/EEC: no classification required

GHS classification (GHS UN rev.3, 2009): no classification required