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EC number: 222-359-4 | CAS number: 3445-11-2
Based on the results obtained in the repeated toxicty study with reproductive and developmental screening by gavage, the NOAEL was determined to be 1000 mg/kg/bw for male and female, the highest dose tested.
According to the standard information requirements of REACH, Annex IX a sub-chronic toxicity study is proposed.
The stability of test substance in drinking water was demonstrated for a period of 7 days at room temperature
Due to the fact that the test substance preparations were true solutions, it was not considered necessary to prove homogeneity through analytical procedures.
CONCENTRATION CONTROL ANALYSIS:
All measured values for N-(2-Hydroxyethyl)-2-pyrrolidon were in the expected range of the target concentrations (90 - 110%), demonstrating the correctness of the preparations.
With regard to the analytical findings of chemical and microbiological contaminants and the duration of application, the diet was found to be suitable. Fed. Reg. Vol. 44, No. 91 of 09 May 1979, p. 27354 (EPA), served as a guideline for maximum tolerable chemical contaminants. The concentration of microorganisms did not exceed 1*10^5/g feed. The individual results are found in the archives of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany.
DRINKING WATER ANALYSIS:
On the basis of the analytical findings, the drinking water was found to be suitable. German Drinking Water Regulation (Trinkwasserverordnung, Bundesgesetzblatt, 05 Dec 1990) served as a guideline for maximum tolerable contaminants. The individual results are found in the archives of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany.
BEDDING AND ENRICHMENT ANALYSIS:
On the basis of the analytical findings, bedding and cage enrichment were found to be suitable. Levels given in Lab Animal (Nov-Dec 1979, pp. 24-34) served as a guideline for maximum tolerable contaminants. The individual results are found in the archives of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany.
no further data available
In a GLP compliant OECD 422 study (BASF SE 2013), the test compound N-(2-Hydroxyethyl)-2-pyrrolidon was administered daily by gavage to treatment groups of 10 male and 10 female Wistar rats at concentrations of 100, 300 and 1000 mg/kg bw/day to test for repeated dose toxicity and screen for potential reproductive and developmental effects. In addition a vehicle control group exposed to the vehicle (water) only was tested as well. Analyses confirmed the overall accuracy of the prepared concentrations and demonstrated the stability of the test substance in drinking water over a period of 7 days at room temperature. No adverse clinical findings were noted. In several male and female high-dose parental animals, salivation was observed after treatment throughout major parts of the treatment period, including the gestation and lactation periods. Since this salivation was transient and occurred directly after dosing, it is probably due to the irritation and/or taste of substance administration, and therefore was not assessed as adverse. No changes in either food consumption or body weight parameters were noted at any dose. Regarding clinical pathology, no treatment-related, adverse effects were observed up to the 1000 mg/kg bw/d dose of the compound. Regarding pathology, no treatment-related organ weight changes, gross lesions or histopathological findings were observed in the parental animals. All organs of the reproduction tract were not affected by treatment. No alterations to parental reproductive performance or fertility were observed at any dose. Thus, under the conditions of this repeated dose and reproduction/developmental toxicity screening test the NOAEL (no observed adverse effect level) for general, systemic toxicity is 1000 mg/kg body weight/day for the F0 parental rats, the highest dose tested.
According to the standard information requirements of REACH Annex IX a sub-chronic toxicity study is proposed by the registrant.
Based on the findings of the repeated dose toxicity study with reproductive and developmental screening, the test substance does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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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