Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-522-5 | CAS number: 657-84-1
There are 6 acute oral, 4 acute dermal and one acute inhalation studies, a number of which are guideline GLP studies, for different hydrotrope substances. By EU criteria these hydrotrope substance are deemed "practically non-toxic" for oral, dermal and inhalation exposure.
There are 6 acute oral, 4 acute dermal and one acute inhalation studies, a number of which are guideline GLP studies, for different hydrotrope substances.
By EU criteria these hydrotrope substance are deemed "practically non-toxic" for oral, dermal and inhalation exposure.
There are a total of 11 acute toxicity studies on the hydrotrope category substances, six by the oral route, four by the dermal route and one by inhalation.
The key acute oral study is a 1982 study with sodium cumene sulphonate which follows OECD 401 guideline but not GLP. It is a limit test of 5 males and 5 females exposed at 7000 mg/kg bw . Two female rats died. There were some clinical signs of stress following dosing but all animals were free of clinical symptoms at 24 hours. There were no effects on body weights and no pathological changes at the 14 day necropsy. The LD50 was recorded as greater than 7000 mg/kg bw and per EU criteria the test substance was deemed "practically non-toxic". The other 5 oral studies show comparable results.
The key acute dermal toxicity is a 1968 study with sodium cumene sulphonate which is generally equivalent to OECD 402. It was a limit test. Six rabbits (3 with shaved and abraded skin and 3 with intact shaved skin) were exposed to 2000 mg/kg bw. There were no deaths but primary irritation was reported at the site of exposure. Body weights were normal at 14 days and there were no gross pathology or histopathology noted at sacrifice. The dermal LD50 is reported as >2000 mg/kg bw. The other three acute dermal studies reported comparable results.
The key acute inhalation study is a 1980 (non-GLP) study with ammonium xylene sulphonate. This is a 232-minute, limit test, involving exposure of male and female rats with no vehicle and a 14-day post exposure observation period. There were no deaths at the 6.41 mg/L dose. Aerosolization was done by a DeVilbiss Nebulizer and exposures were in glass chambers. One of the 10 animals demonstrated clinical signs (soft stool), 2 of the 10 had slight weight gains at days 7 and 14, and 5 of the 10 showed slight mottling or a moderate congestion of lungs at necropsy. The conclusion was reported as "practically nontoxic".
The available studies with oral, dermal and inhalation exposure demonstrate that the members of the hydrotrope category are of low acute toxicity. No classification is warranted.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again