Registration Dossier
Registration Dossier
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EC number: 928-729-8 | CAS number: 188416-20-8
Endpoint summary
Administrative data
Description of key information
Two studies are available:
1) A repeated dose 28-day oral toxicity study by daily gavage in rat (Huntingdon Life Sciences Ltd, 1999) is available which is key study. This study showed that No Observed Adverse Effect Level (NOAEL) for the test substance is 500 mg/kg.
2) A dose range finding study (Huntingdon Life Sciences Ltd, 1999) is available which is supporting study. It is conducted that, although it was not possible to establish a clear No-Observed-Effect Level(NOEL) from this study, the NOAEL was considered to be 500 mg/kg/day and that dosages up to this could be used in the fourthcoming four week study in this species.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- 1 (reliable without restriction)
Additional information
Repeated dose toxicity: oral
Two studies are available:
1) A repeated dose 28-day oral toxicity study by daily gavage in rat (Huntingdon Life Sciences Ltd, 1999) was conducted according to EU Method B.7. key study. This study showed that No Observed Adverse Effect Level (NOAEL) for the test substance is 500 mg/kg.
2) A dose range finding study (Huntingdon Life Sciences Ltd, 1999) is available which is supporting study. It is conducted that, although it was not possible to establish a clear No-Observed-Effect Level(NOEL) from this study, the NOAEL was considered to be 500 mg/kg/day and that dosages up to this could be used in the fourthcoming four week study in this species.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Study run to a method comparable with current guidelines and to GLP
Justification for classification or non-classification
Oral: LOAEL > 2000 mg/kg bw in a study (NOAEL is 500 mg/kg for 28 days)
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.9.2 and 3.9.3 the substance is not classified for the repeated oral toxicity endpoint.
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.
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