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EC number: 205-117-2 | CAS number: 133-66-4
Read across to the a close structural analogue (CAS No 16090-02-1)oral: subacute (28 day, gavage): NOAEL = 825 mg/kg bw/day, OECD 407 and GLP compliant study
Based upon the results obtained in this study, the "no-adverse-effect-level" of the test substance is 1000 mg/kg body weight for male and female rats (825 mg/kg bw/d; based on the active substance content of 82.5%) when administered orally by gavage for a period of 28 days followed by a treatment-free 14-day recovery period.
The various statistically significant differences observed (increase/decrease) in food consumption (absolute/relative) and organ weights (relative) were considered to be of no toxicological relevance and did therefore not provide any evidence of toxicity of the test substance at any of the dose levels tested.
Reliable data on repeated dose toxicity are available for a close structural analogue (CAS 16090 -02 -1).
In a GLP compliant subacute 28-day toxicity study following OECD testing guideline 407, the test substance was administered daily by gavage to SPF-bred Wistar rats. The test substance was administered to 4 groups each of 5 male and 5 female SPF-bred Wistar rats by oral gavage at daily doses of 0, 50, 200, 1000 mg/kg bw/day (corresponding to 0, 41, 165 and 825 mg/kg bw/day of active ingredient) for 28 consecutive days (CIBA-Geigy AG, Switzerland 1991b). Two groups of 5 male and 5 female rats were treated accordingly at 0 and 825 mg/kg bw/day for 28 days followed by a 14-day treatment free recovery period. The dose levels used in this study are based on data from acute and subacute studies, especially a subacute 5-day range-finding study (CIBA-Geigy AG, Switzerland 1991a) in which dose levels of 0, 200 and 1000 mg test substance per kg body weight and day were administered to rats. There were no compound related effects in mortality, clinical signs, body weight, food consumption, hematology, clinical chemistry, urinanalysis, organ weights, or gross and histologic pathology observed after 4 weeks of treatment nor at termination of the treatment-free recovery period when the results from the animals of the test article treated groups were compared to those of the control animals. Based upon the results obtained in this study, the "no-adverse-effect-level" of the test substance is 1000 mg/kg body weight (825 mg/kg bw/day active ingredient) for male and female rats when administered orally by gavage for a period of 28 days followed by a treatment-free 14-day recovery period. The various statistically significant differences observed (increase/decrease) in food consumption (absolute/relative) and organ weights (relative) were considered to be of no toxicological relevance and did therefore not provide any evidence of toxicity of the test substance at any of the dose levels tested.
Therefore, it is concluded by read-across that the substance with CAS 133 -66 -4 is not toxic when administered orally to rat over 2 years and have not to be classified for repeated oral toxicity.
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the family members are not considered to be classified for repeated toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the family members are not considered to be classified for repeated toxicity under 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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