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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 225-897-8 | CAS number: 5137-70-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 12 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The studies are GLP compliant with a high quality (Klimisch score = 1).
Additional information
In a OECD 421 study, OPA was administered to male and female Spargue-Dawley rats, 10/dose/sex, by oral gavage at the dose levels of 0, (vehicle), 12, 30, 80 mg/kg bw/day. The test substance was administered by gavage every day from 14 days prior to the start of mating, until day 5 post-partum for the females and at least for 5 weeks for the males.
At necropsy, A few treatment-related changes were seen at necropsy in kidneys, forestomach and thymus.
Kidney treatment-related changes were seen in both sexes at 80 mg/kg/day, but particularly in females and at 30 mg/kg/day in females. These included tubular necrosis, present in one high-dose group female but mainly basophilia and tubular dilation with peritubular mononuclear cell infiltrate (occasionally associated with a few fibroblasts). Mixed cell infiltrate was seen in papilla in females given 80 mg/kg/day. Granular casts and cellular debris (mix of desquamed and inflammatory cells including granulocytes) were seen in tubules. At 12 mg/kg/day, no treatment-related changes were seen in kidneys. Tubular basophilia was seen at a slightly higher incidence than in the control group, however as this was seen unilaterally and focally, any relationship with the test item was considered to be unlikely at this dose-level.
In conclusion, the NOAEL is 12 mg/kg bw/day based on the kidney changes.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one study available
Justification for classification or non-classification
Octylphosponic acid is classified for repeated dose toxicity as STOT RE 2 (H373) according to the criteria of the Regulation (EC) N° 1272/2008 based on:
- In the OECD 421 study, the LOAEL is 30 mg/kg bw/day. In this study, the rats were exposed for more than 40 days (between 40 and 50 days depending on the sex) which is a longer exposure compared to a subacute toxicity study (28-days). Effects were seen in kidney from the dose of 30 mg/kg bw/day.
These values and classification are therefore retained also for Dodecylphosphonic acid.
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.
