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REACH

Acetylcysteine

EC number: 210-498-3 | CAS number: 616-91-1

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Table 1: Overview of published results of repeated dose studies (subacute)

Source	Species	Route of exposure	Duration	Concentration
Toxicologist 44,160, 2005	Rat	Oral	30 days	TDLo 1.8E+4 mg/kg
Toxicologist 78, 212, 2004	Rat	Oral	30 days	TDLo 1.8E+4 mg/kg
International Journal of Toxicology 23, 239, 2004	Rat	Oral	30 days	TDLo 1.8E+4 mg/kg
Archives of Toxicology 79, 531, 2005	Rat	Oral	4 weeks	TDLo 16.8 g/kg
European Journal of Pharmacology 519, 118, 2005	Rat	Oral	3 weeks	TDLo 2.52E+4 mg/kg
European Journal of Pharmacology 543, 151, 2005	Rat	Oral	30 days	7.5 mg/kg
European Journal of Pharmacology 544, 118, 2006	Rat	Oral	8 weeks	80640 mg/kg
Toxicology 219, 197, 2006	Rat	Oral	21 days	TDLo 1.05E4 mg/kg
Neurotoxicology 28, 83, 2007	Rat	Oral	14 days	TDLo 2800mg/kg
Toxicology 243, 317, 2008	Rat	Oral	22 days	TDLo 2.31E4mg/kg
Toxicology 243, 207, 2008	Rat	Oral	22 days	TDLo 2.31E4mg/kg
Carcinogenesis 26, 657, 2005	Mouse	Oral	42 days	4.2E+5 mg/kg
Brazilian Journal of Medical and Biological Research 41, 765, 2008	Rat	Oral	28 days	TDLo 1.5995E+04 mg/kg
British Journal of Pharmacology 154, 136, 2008	Rat	Oral	7 days	TDLo 7 g/kg
Human & Experimental Toxicology 28, 221, 2009	Rat	Oral	4 weeks	TDLo 3360 mg/kg
Fundamental & Clinical Pharmacology 20, 247, 2006	Rat	Oral	8 days	TDLo 400 mg/kg
Clinical and Experimental Pharmacology and Physiology 35, 979, 2008	Rat	Oral	15 days	TDLo 18.75 g/kg
Carcinogenesis 30, 1008, 2009	Rat	Dermal	4 weeks	TDLo 6528.4 µg/kg
Food and Chemical Toxicology 49, 1404, 2011	Rat	Oral	28 days	TDLo 2800 mg/kg
L. BONANOMI, A. GAZZANIGA. Toxicological, Pharmacokinetic and Metabolic Studies on Acetylcysteine. Eur J Respir Dis (1980) 61, Suppl. 111, 45-51	Rat /Dog	Oral	4, 12, 28 or 52 days	max. 300 - 2000 mg/kg No effects observed
Acker-Mills, B. et al. Effects of N-Acetylcysteine on Thresholds and Otoacoustic Emissions Following Noise Exposure. Conference paper. 2005(19):00057 NTIS Order Number: ADA433105/XAB	Rat	Oral	30 days	600 oder 1200 mg/kg bw/d histopathology: no effects, ALT, GST activity and tissue GSH elevated
Petersone, I. et al. Toxicological study of the mucolytic substance N-acety-L-cysteine. Eksperimental'naya i Klinicheskaya Farmakoterapiya (1972), No. 3, 5-15 CODEN: EKFMA7; ISSN: 0367-0589	Rat	Oral	1 month	100, 500 and 1000 mg/kg/d
Arfsten, D. et al. Impact of 30-day oral dosing with N-acety-L-cysteine on Sprague-Dawley rat physiology. International journal of toxicology, (2004 Jul-Aug) Vol. 23, No. 4, pp. 239-47. Journal code: 9708436. ISSN: 1091-5818. L-ISSN: 1091-5818.	Rat	Oral	30 days

Table 2: Overview of published results of repeated dose studies (subchronic)

Source	Species	Route of exposure	Duration	Concentration
Phytomedicine 20, 828, 2013	Rat	Oral	12 weeks	2100 mg/kg

Justification for classification or non-classification

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