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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-910-8 | CAS number: 111-81-9
Endpoint summary
Administrative data
Description of key information
A read-across from the 90-days repeated dose subchronic toxicity study on the structural analogue sodium salt undecylenic acid is being proposed.
This read-across is based on the following justification.
Referring to ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.6: QSARs and grouping of chemicals", endpoint information is read-across from a structural analogue. A structural analogue is a source chemical whose physico-chemical and toxicological properties are likely to be similar to the target chemical as a result of structural similarity. The similarity may be based on a common precursor and/or breakdown product, that results via physical or biological processes (metabolic pathway similarity). This is used to examine related chemicals, such as acid/ester/salt.
Since the target chemical methyl-10-undecenoate is the methyl ester of the source chemical undecylenic acid, read-across between the two substances based on structural analogy therefore technically is possible. The scientific justification for the read-across of the study on oral repeat dose toxicity from undecylenic acid to methyl-10 –undecenoate is based on the similiar behaviour of the two substances observed during the six in-vivo studies on acute effects :
- Acute oral toxicity: methyl-10 -undecenoate is classified as category 4, which is the lowest toxicity category. Since the LD50 of methyl-10 -undecenoate (1563 mg/kg) still is in the same order of magnitude compared to the LD50 of undecylenic acid (> 2000 mg/kg), the observed slight differences of the acute oral toxic effect should be insignificant in a repeated dose toxicity study.
- Acute dermal toxicity, and skin sensitization: both substances with the same results "not classified".
- Acute inhalative toxicity: methyl-10 –undecenoate is classified as category 4, which is the lowest toxicity category ...
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 60 mg/kg bw/day
Additional information
The 13 week oral repeated dose toxicity study perfomed with sodium salt undecylenic acid was used for evaluation of Methyl-10 -undecenoate. Read accross of the in vivo data should be justified based on the comparable chemical structure of both substances and because it was demonstrated that Methyl-10 -undecenoate undergo rapid hydrolysis to undecylneic acid under gastric pH conditions.
In the GLP 13 weeks oral toxicity study performed according to OECD 408, treatment with the undecylenic acid at 20, 60 and 180/360 mg/kg/day did not result in mortality. The observed signs included ptyalism, loud breathing/respiratory difficulties and poor clinical condition. Body weight gain and food consumption were reduced in males of the high dose group, especially after dose increase starting day 50 of the study. Reduced glucose plasma levels and reduced triglyceride-levels were found in females of the high dose group, the first being reversible and the latter not reversible in the treatment-free period. Histopathology revealed cardiomyopathy in some animals of the highest dose group (myocardial degeneration/monocellular aggregation) which was reversible during treatment free period. Forestomach oedema/inflammatory cell infiltration was observed in the high dose group. There were no treatment related effects in the low and intermediate dose-groups.
Under the experimental conditions, the 13 week oral toxicity study derived LOAEL for the source chemical sodium salt of undecylenic acid was 180 mg/kg BW.
Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: heart
Justification for classification or non-classification
With a LOAEL of > 180 mg/kg bw / day in the 90-days repeated dose subchronic oral study toguether with reversible observed target effects (cardiomyopathy), the substance is not classified as to its chronic toxic properties according to EU regulation (EC) No. 1272/2008 (CLP).
According to EU 67/548/ECC classification system, the substance is not classified. No serious damage was observed in the repeated oral study.
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.
