Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 401-300-8 | CAS number: 86168-95-8
Endpoint summary
Administrative data
Description of key information
In a subacute study with rats (Ciba-Geigy, 1986) the test substance did not cause any adverse effects up to the highest dose tested (1000 mg/kg), therefore, the NOAEL was set at 1000 mg/kg bw.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
In a GLP-compliant subacute rat study (OECD 407), a total of 40 RAIf rats (5 males and 5 females per dose group) were dosed by gavage with 0, 40, 200 and 1000 mg/kg body weight daily for 28 days (Ciba-Geigy, 1985). No relevant clinical signs and no mortalities related to administration of the test substance were observed during the treatment or recovery periods. No changes to body weight gain food consumption and water consumption were noted. In hematology, a minor increase in the percentage of segmented neutrophils was found in males and females of the high dosage group (1000 mg/kg bw), but the difference to controls was not reaching a level of statistical significance. Blood chemistry analysis revealed a minor (statistically not significant) increase in aspartate aminotransferase activity in the male group 4, treated with 1000 mg/kg bw, but no changes attributable to the treatment with the test article were found. Besides some incidental findings in organ weight parameters and microscopy investigations, no effects of toxicological significance attributed to treatment were observed. Therefore, the NOAEL was set at 1000 mg/kg/day under the conditions of this study.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the present data, classification for repeated dose oral toxicity is not warranted under Directive 67/548/EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the present data, classification for repeated dose oral toxicity is not warranted 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.
