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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 211-720-1 | CAS number: 691-37-2
Endpoint summary
Administrative data
Description of key information
The NOAELs for systemic toxicity are considered to be 40 mg/kg/day for males and 200 mg/kg/day for females (OECD 422).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
The NOAELs for systemic toxicity are considered to be 40 mg/kg/day for males and 200 mg/kg/day for females. Dermal and inhalation exposure is not expected because the substance is imported into Europe in polymerised (non-available) form. Furthermore company specific analytical data demonstrates that the amount of residual monomer is present at a very low concentration of 14-20ppm as 4-methylpent-1-ene. As a result, further testing on vertebrate animals is contraindicated.
Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys
Justification for classification or non-classification
The substance is not considered to be classified based upon the following:
1) The kidney changes are seen in male rats only and hence most likely to relate to hydrocarbon nephropathy . This is a rodent only phenomenon and so should be taken into account for risk assessment/classification.
2) The basis for classification is the dose level. The benchmark dose period is the 90 day study which I believe is used to derived the DNEL. The cut off points are multiplied by 3 for the 28 day study as it is a third of the duration of dosing. The study involved here is a OECD422 study where the dosing is somewhere between 45 and 50 days of dosing. Hence, a multiple of 2 has been used instead of 3.
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.
