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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Additional information

Table 1: Human data

Source

Observation

Concentration

David J. et al., Liver Injury After Oral and Rectal Administration of N-Acetylcysteine for Meconium Ileus Equivalent in a Patient With Cystic Fibrosis, Pediatrics

February 1987, VOLUME 79 / ISSUE 2

A 3-year old boy was treated with the test via different routes for 3 days. Severe hepatic dysfunction occurred on two occasions after the administration of NAC for the treatment of meconium ileus equivalent.

TDLo = 8480 mg/kg

van Zandwijk N. et al., EUROSCAN, a randomized trial of vitamin A and N-acetylcysteine in patients with head and neck cancer or lung cancer. For the European Organization for Research and Treatment of Cancer Head and Neck and Lung Cancer Cooperative Groups. J Natl Cancer Inst. 2000 Jun 21;92(12):977-86.

Human, 2-year administration; route not reported

TDLo = 3650 mg/kg

Cancer Epidemiology Biomarkers & Prevention,11,167, 2002

human, oral administration, 24 weeks

TDLo = 1.54 g/kg

Kim J., et al (correspondence). Response to Letter to the Editor on "Effect of N-acetylcysteine on liver recovery after resection. A randomized clinical trial". Journal of Surgical Oncology, (1 Nov 2016) Vol. 114, No. 6, pp. 774. Refs: 2 ISSN: 0022-4790; E-ISSN: 1096-9098 CODEN: JSONAU

Human, occupational contact dermatitis in adults

 

Beuhler, Michael C., Dr. (correspondence), Dulaney, Anna R. Further case details regarding IV N-acetylcysteine overdoses. Clinical Toxicology, (November 2011) Vol. 49, No. 9, pp. 878. Refs: 3 ISSN: 1556-3650; E-ISSN: 1556-9519

Human, occupational contact dermatitis, effects of overdose