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EC number: 201-174-2
CAS number: 79-07-2
Oral acute toxicity of Chloroacetamide was tested according to standard acute method in rats, mice, rabbits and dogs, resulting in an LD50 of 138 mg/kg bw in rats as relevant threshold for classification. Dermal acute toxicity was tested according to standard acute method in rats, resulting in an LD50 >2000 mg/kg bw. Inhalation acute toxicity was scientifically unjustified due to low vapour pressure.
Table 1. Results
Number of dead animals/ number of tested animals
Chloracetamid was tested after single oral gavage
in female SPF-Wistar rats. Preliminary tests demonstrated higher
sensitivity in female animals. The rats were fasted for 16 hours before
and 2 hours after application. The animals were observed 14 days after
application and weighed weekly. Deadly poisoned animals were dissected
and assessed macroscopically; these animals showed impaired balance,
gasping breathing and bended posture. After the study period, surviving
animals were sacrificed and dissected macroscopically. No
macroscopically effects were observed. Chloracetamid had an LD50 of 138
mg/kg bw and is classified as moderately toxic according to W.S. SPECTOR
in the “Handbook of Toxicology”.
Acute dermal toxicity of Chloroacetamide was tested
in 5 male and 5 female Sprague-Dawley rats at a dose of 2000 mg/kg bw
under occlusion. At the end of the dermal exposure period of 24 hours
the bandage was removed and the treated skin area washed with warm water
in order to remove any unabsorbed remnants of the test substance. The
observation period after the dermal administration lasted for 14 days.
No deaths and no symptoms occurred. The skin of the
animals showed no signs of irritation. Three female animals showed a
disturbance of body weight gain during the first week of the study,
which returned to normal until the end of the study. In all other
animals development of body weight was not impaired. The animals killed
at the end of the observation period showed no macroscopically visible
Based on the results obtained in this study the acute dermal LD50 of
Chloroacetamide for male and female rats is greater than 2000 mg/kg body
In a key oral acute toxicity study in female rats
dosed at 80, 125, 160, 200 and 320 mg/kg bw, Chloroacetamide had an LD50
of 138 mg/kg bw (Hoechst, 1976). Deadly poisoned animals (125, 160, 200
and 320 mg/kg bw) showed impaired balance, gasping breathing and bended
posture; no macroscopically effects
Supporting data were available for other species
(Hoechst, 1958; Expert Panel on Cosmetic Ingredients, 1991):
- The acute oral LD50 of Chloroacetamide in mice
according to standard method (non-GLP) was 150 mg/kg bw
- The acute oral LD50 of Chloroacetamide in dogs
according to standard method (non-GLP) was 31 mg/kg bw.
In another supporting study (IBR ,1988), acute oral
toxicity testing of a formulation containing 70% Chloroacetamide & 30%
sodium benzoate, provided LD50 values of 275 and 306 mg/kg bw in male
and female rats. Reduced activity (apathy),tonic/clonic convulsions,
tremor and twitches, disturbance of coordination, cyanosis, piloerection
and reduced respiration rate were observed in the dosed animals.
Post-mortem changes included residues of the sample and redness of the
mucous membrane of the digestive tract. Nothing abnormal was found in
the animals necropsied on day 14.
Acute inhalation testing was waived as the vapor pressure
of Chloroacetamide was very low (0.0026-0.0078 hPa measured at 20 -30
°C; 0.0106 mm Hg calculated at 25°C). Based on Column II of REACH
annexes, inhalation toxicity testing is scientifically unjustified.
In a key acute dermal toxicity limit study
conducted under GLP (Aventis ProTox , 2001), Chloroacetamide tested in
male and female Sprague-Dawley rats resulted in an LD50 greater than
2000 mg/kg bw under occlusion according to OECD 404 method.
No deaths, clinical observations nor gross patholological changes
occurred. The skin of the animals showed no signs of irritation. Three
female animals showed a disturbance of body weight gain during the first
week of the study, which returned to normal until the end of the study.
In all other animals development of body weight was not impaired. The
animals killed at the end of the observation period showed no
macroscopically visible changes. Based on the results obtained in this
study the acute dermal LD50 of Chloracetamide for male and female rats
is greater than 2000 mg/kg body weight.
Finally, supporting data of lower
reliability were also available for other routes; some examples are
provided below, however these were not further taken into account for
- The acute intraperitoneal LD50 in mice was reported to
be 130 mg/kg bw (Kemper, 1989; IBR, 1979) or 100 -150 mg/kg bw (Expert
Panel on Cosmetic Ingredients, 1991)
- Intraperitoneal administration of 75 mg/kg bw in rats
indicates that hepatic GSH depletion leads to lipid peroxidation, which
can be significantly increased without causing permanent damage to
hepatocytes (Anundi et al., 1980)
- The acute intraperitoneal LD50 in rats was 50 mg/kg bw
Chloroacetamide was classified according the EU labelling
regulations Commision Directive 93/21/EEC as HARMFUL with symbol 'Xn'
and risk phrase R 25 'HARMFUL IF SWALLOWED'. According to CLP regulation
(No. 1272/2008 of 16 December 2008), Category 3 classification is
proposed with Signal word 'Danger' and hazard statement H301 'TOXIC IF
Based on these results and according to the EC Directive
(No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008),
Chloroacetamide does not have to be classified and has no obligatory
labelling requirement for dermal toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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