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Table 2 Safety tests of hyaluronan

From: Ingested hyaluronan moisturizes dry skin

Test procedure

Substance

Origin

Molecular weight

Subject

Result

Reference

Daily oral administration test for 8 weeks

HA

Chicken comb

9 × 105

Human

No abnormalities in hematology due to 240 mg/kg body weight/day for 12 weeks

Sato, T. et al. (2009) [63]

Daily oral administration test for 1 year

HA

Chicken comb

9 × 105

Human

No abnormalities on clinical observations due to oral administration of 200 mg/kg body weight/day for 1 year

Tashiro, T. et al. (2012) [7]

Single-dose toxicity test

Sodium hyaluronate

Chicken comb

Not shown

Mouse

LD50 (mg/kg body weight) > 2400

Nagano, K. et al. (1984) [55]

LD50 (mg/kg body weight) > 1200

Nagano, K. et al. (1984) [56]

Sodium hyaluronate

Chicken comb

Not shown

Rat

LD50 (mg/kg body weight) > 800

Nagano, K. et al. (1984) [55]

LD50 (mg/kg body weight) > 1200

Nagano, K. et al. (1984) [56]

Microbial fermentation

16.8 × 105

LD50 (mg/kg body weight) > 200

Morita, H. et al. (1991) [57]

Sodium hyaluronate

Chicken comb

Not shown

Rabbit

LD50 (mg/kg body weight) > 1000

Nagano, K. et al. (1984) [55]

LD50 (mg/kg body weight) > 900

Nagano, K. et al. (1984) [56]

Repeated-dose toxicity test

HA

Microbial fermentation

3 × 105

rat

No abnormalities on clinical observations due to administration in doses equivalent to 0, 34, 235, 3536 mg/kg body weight/day.

Oe, M. et al. (2011) [58]

Sodium hyaluronate

Chicken comb

Not shown

NOAEL 48 mg/kg body weight, or more

Ishihara, M. et al. (1996) [59]

Antigenicity test

Sodium hyaluronate

Microbial fermentation

18.8 × 105

Bacteria (Ames test)

No mutagenicities to S. typhimurium (TA1535, TA1537, TA98, or TA100) or E.coli (WP 2 urA)

Sugiyama, C. et al. (1991) [60]

  

Not shown

21.2 × 105

 

No mutagenicities to S. typhimurium (TA98, TA100, TA1535, or TA1537) or E.coli (2 urA)

Onishi, M. et al. (1992) [61]

  

Chicken comb

20.0–21.2 × 105

Mouse, rat, rabbit

No antigenicity on PCA reaction in mice or guinea pigs

Takemoto, M. et al. (1992) [62]

     

No antigenicity on active systemic anaphylactic reaction in guinea pigs

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