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EC number: 200-609-3 | CAS number: 65-45-2
Oral: LD50= 980 mg/kg bw (C.I. 817-1176 mg/kg bw), male, rat, OECD 401, Boxill 1958Oral: LD50 >1600 <2000 mg/kg bw, rat, OECD 401, Ichniowski 1946Oral: LD50=1400 mg/kg bw, rat, no guideline, Hart 1947Oral: LD50=1200 (960-1500) mg/kg bw, male/female, rat, no guideline, Way 1953Oral: LD50=1600 mg/kg bw, rat, no guideline, Bekemeier 1955Oral: LD50=1490 mg/kg bw, rat, no guideline, Drebinger 1952
AD50 (amount required to produce significant analgesia in 50 % of the rats): 60 mg/kg
Median analgetic dose (AD50): 440 (373 - 520) mg/kg body weight
More toxic by slow intravenous injection: 300 mg/kg body weight lethal.
No irritating effect on skin: 20% salicylamide ointment causes no skin erythema (no species stated).
Human data (self-test of the author): Daily administration of 3 - 6 g salicylamide for 8 days causes no proteinuria.
Oral toxicity to rats
A large body of information on the acute toxicity of salicylamide is available from articles following scientific standards and published in peer-reviewed journals, but all studies were performed before the introduction of OECD testing guidelines and GLP. However, compared with present-day methods, much larger numbers of animals were tested, and the agreement between different authors is high, independent of possible differences in animal strains, vehicles, and other experimental parameters: For the oral LD50 in rats, values from 980 to 1600 mg/kg bw are reported.
The study by Boxill (1958) is considered to be the most conservative and reliable, based on the quantity of information (including statistical confidence limits) reported, although only males were tested, and the observation period was only 7 days. No sex-specific LD50 values are reported in any of the studies, therefore the more susceptible sex cannot be determined. However, the value for males given by Boxill, 980 mg/kg bw, is 20% less than the lowest value for both sexes, 1200 mg/kg bw (Way, 1953). Since all deaths reported in rats by any of the authors occurred hours or (at latest) a few days after application, it is also unlikely that the limited observation time compromised the result. The lowest LD50, for male rats at 980 mg/kg bw, is selected as the most conservative value and is carried forward for risk assessment and classification and labelling.
Oral toxicity to other species
A wide variety of species was tested and compared with rats. Mice (1100-1400 mg/kg bw) and guinea pigs (1730-1800 mg/kg bw) had LD50 values similar to those found in rats, whereas rabbits (>3000 mg/kg bw) were less responsive. The only reported value for dogs (>800 mg/kg bw, no mortality) does not indicate any particular susceptibility, since no higher doses were tested. In cats, on the other hand, an almost tenfold lower LD50 (<150 mg/kg) and a completely different mode of action was observed. Deaths were delayed by several days, and were caused by kidney failure (glomerulo-tubulonephrosis and uremia), whereas in all other species, respiratory paralysis was the cause of death. This is a well known species-specific effect (Bekemeier, H., Proceedings of the European Society of Toxicology, 1975, 16, 229 -232).
Other routes of application
No experimental data were found on dermal and inhalation toxicity. However, two consistent values for the intraperitoneal LD50 exist: 500 -1000 mg/kg bw (Ichniowski 1946), and 600 mg/kg bw (Way 1953).
The available acute oral toxicity data is considered to be complete and adequate for risk assessment and classification and labelling, based on a weight-of-evidence approach, according to Regulation (EC) No. 1907/2006, Annex XI, section 1.2.
Justification for selection of acute toxicity – oral endpoint A large body of information on the acute toxicity of salicylamide is available from articles following scientific standards and published in peer-reviewed journals, but all studies were performed before the introduction of OECD testing guidelines and GLP. The study by Boxill (1958) is considered to be the most conservative and reliable, based on the quantity of information (including statistical confidence limits) reported, although only males were tested, and the observation period was only 7 days.
Acute Oral Toxicity
The key value selected for the acute oral toxicity, LD50=980mg/kg bw leads to the classification of the substance as Category 4, H302, Harmful if swallowed, according to the criteria in Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.1.2.
Acute Dermal and Inhalation Toxicity
No experimental data are available which are suitable for the purposes of classification and labelling.
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