Glycollic acid

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

other: conclusion

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The occupational health nurse responsible for the production plant confirmed no medical reports of adverse effects to staff working in the production area. Reviews of published literature and an Australian Regulatory submission for use of cosmetic glycolic acid, revealed studies where glycolic acid exposures have been encountered. So, further studies are unnecessary. The combined data provide evidence for the hazard endpoint that is sufficient for the purpose of classification and labelling and risk assessment.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

other: conclusion

Title:

Unnamed

Year:

2007

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1940

Report date:

1940

Reference 3

Reference Type:

publication

Title:

No information

Author:

Gabow, P. A. et al.

Year:

1986

Bibliographic source:

Ann. Intern. Med. (1986) 105(1):16-20

Reference 4

Reference Type:

publication

Title:

No information

Author:

Hewlett, T. P. et al.

Year:

1986

Bibliographic source:

J. Toxicol. Clin. Toxicol. (1986) 24(5):389-402 (TOXBIB/87/061145)

Reference 5

Reference Type:

publication

Title:

No information

Author:

Jacobsen, D. et al.

Year:

1988

Bibliographic source:

Am. J. Med. (1988) 84:145-152 (IPA/88/790178

Reference 6

Reference Type:

publication

Title:

No information

Author:

Milhorat, A. T. and V. Toscani

Year:

1936

Bibliographic source:

J. Biol. Chem. (1936) 114:461-466 (CA30:71919)

Materials and methods

Study type:

clinical case study

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Various case study summaries reviewed or published literature reviewed for clinical information

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Glycollic acid

EC Number:

201-180-5

EC Name:

Glycollic acid

Cas Number:

79-14-1

Molecular formula:

C2H4O3

IUPAC Name:

2-hydroxyacetic acid

Details on test material:

Glycolic acid

Results and discussion

Any other information on results incl. tables

Supplementary reference, DuPont, 1940. There were no toxic or abnormal symptoms in five human subjects who orally ingested 2.25 g of glycolic acid daily for 12 weeks or in five human subjects after 36 weeks. The glycolic acid was contained in five 500 mg capsules containing a mixture of 16.7% glycolic acid, 16.6% of the Ca salt, 50% of the Na salt, and 16.7% of the polyacid.

Supplementary reference, Milhorat and Toscani, 1936 There were no toxic symptoms in patients with muscular dystrophy who were orally given glycolic acid and NaHA at levels of 250-400 mg/kg/day for up to seven days. The authors did not believe that glycolic acid was converted to oxalic acid in humans.

Supplementary reference, Gabow et al., 1986 Ethylene glycol intoxication produces a severe metabolic acidosis with an increased anion gap. The authors examined three patients with this intoxication to identify the organic acids that cause acidemia in humans and to determine how effectively these acids can be removed during dialysis. All patients had markedly elevated glycolic acid levels of more than seven meq/L; two patients had lactic acidosis, with lactic acid levels of greater than 5.0 meq/L. Hemodialysis clearance of glycolic acid was 105 mL/minute, and 159 meq was removed in three hours. After hemodialysis using a bicarbonate dialysate, the mean anion gap decreased from 34 to 23 meq/L; the mean serum bicarbonate concentration increased from 5.5 to 20 meq/L. Therefore, glycolic and lactic acids are important in the acidosis caused by ethylene glycol intoxication in humans. Hemodialysis treatment with a bicarbonate dialysate is an efficient method for removing glycolic acid and resolving acidemia.

Supplementary reference, Hewlett et al., 1986. Glycolic acid is the ethylene glycol metabolite that accumulates in the highest concentration in the blood and may be the major contributing factor to its acute toxicity. Serum and urine levels of glycolic acid have been found to correlate directly with clinical symptoms and mortality in poisoning cases, making it a valuable diagnostic tool.

Supplementary reference, Jacobsen et al., 1988. Ethylene glycol (EG) and glycolate (glycolic acid) pharmacokinetics were studied in two adult patients who had ingested antifreeze. Therapy with i.v. ethyl alcohol was discussed. The patients had maximal EG concentrations of 40.9 and 56.4 mM/L, respectively. Both patients survived, but with prolonged renal failure. Glycolic acid was the major cause of the metabolic acidosis in each case. Kinetic calculations showed that both EG and glycolate were distributed in total body water with plasma half-lives of 8.4 and seven hours, respectively. The half-life of EG was increased more than 10-fold by ethyl alcohol treatment alone. Calcium oxalate monohydrate crystalluria was dominant in both cases

Applicant's summary and conclusion

Conclusions:

No clinical cases of poisoning by administration by glycolic acid were available. The occupational health nurse responsible for the production plant confirmed no medical reports of adverse effects to staff working in the production area. Reviews of published literature and an Australian Regulatory submission for use of cosmetic glycolic acid, revealed studies where glycolic acid exposures have been encountered.

Executive summary:

No clinical cases of poisoning by administration by glycolic acid were available. The occupational health nurse responsible for the production plant confirmed no medical reports of adverse effects to staff working in the production area. Reviews of published literature and an Australian Regulatory submission for use of cosmetic glycolic acid, revealed studies where glycolic acid exposures have been encountered.