Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 939-514-3 | CAS number: 1471312-26-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Oral (OECD 401), rat: LD50 > 5000 mg/kg bw (limit test)
Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw (limit test)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 2) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Additional information
Oral
A GLP-conform acute oral toxicity study with Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters was investigated in male and female Wistar rats according to OECD guideline 401 (Biffi, 1992). The test substance in vehicle (sesame seed oil) was administered by gavage to groups of 5 animals per sex at a limit dose of 5000 mg/kg bw. No mortalities and no clinical signs were observed up to the end of the 14-day observation period. Body weights were not affected by treatment with the test substance. The necropsy and histopathological examination did not reveal substance-related findings. Based on the results, the oral LD50 value for male and female rats was greater than 5000 mg/kg bw.
Supporting information on acute oral toxicity is available for the target substances and expected hydrolysis products 2-Hydroxypropanoic acid (CAS 50-21-5, Lactic acid) and Alcohols, C12-13-branched and linear (CAS 75782-86-4, former CAS 67762-41-8). Alcohols, C12-13-branched and linear (CAS 75782-86-4) was investigated in an oral acute toxicity study in 3 male and 3 female Wistar rats according to OECD guideline 423 (Prinsen, 1998). Since no mortalities were noted during the 14-day observation period, the oral LD50 value for rats was considered to be greater than 2000 mg/kg bw. The study on the acute toxicity of the physiologically occurring metabolite 2-Hydroxypropanoic acid (L-Lactic acid) resulted in an oral LD50 value for rats of 3730 mg/kg bw (Andersen, 1998). No mortality occurred even after repeated oral administration of 5000 mg/kg bw/d in a subchronic oral toxicity study conducted with the read-across substance Tetradecyl 2-hydroxypropionate (CAS 1323-03-1). 10 Sprague Dawley rats per sex and group received undiluted test substance 5 days/week at dose levels of 500; 2500 and 5000 mg/kg/day for a period of 13 weeks (Faurot and Pennisi, 1985). An additional group of 10 animals per sex were sham-exposed and served as control group. All animals survived until study termination and their appearance and behaviour were not adversely affected by treatment. Thus the LD50 was considered to exceed 5000 mg/kg bw.
Inhalation
This information is not available.
Dermal
An acute dermal toxicity study was performed with Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters similar to OECD guideline 402 (Biffi, 1993). Five male and five female rats were dermally exposed to the undiluted test substance at 2000 mg/kg bw for 24 h under occlusive conditions. Following exposure and up to the end of the 14-day observation period, no mortality occurred and no clinical signs or changes in body weight were observed. Therefore, the dermal LD50 in male and female rats was greater than 2000 mg/kg bw.
Supporting information on acute dermal toxicity is available for the target substance and expected hydrolysis product Alcohols, C12-13-branched and linear (CAS 75782-86-4, former CAS 67762-41-8). Alcohols, C12-13-branched and linear (CAS 75782-86-4) was investigated in an acute dermal toxicity study in 5 male and 5 female Wistar rats according to OECD guideline 402 (Prinsen, 1998). Since no mortalities were noted during the 14-day observation period, the dermal LD50 value for rats was considered to be greater than 2000 mg/kg bw.
Conclusions for acute toxicity
An acute oral toxicity study is available for the target substance Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters, in which no mortalities or adverse systemic effects in rats were observed. Based on these results, an oral LD50 value > 5000 mg/kg bw was derived. Likewise, the expected hydrolysis products Hydroxypropanoic acid (CAS 50-21-5, Lactic acid) and Alcohols, C12-13-branched and linear (CAS 75782-86-4) showed LD50 values exceeding the limit dose of 2000 mg/kg bw. In addition, no mortality occurred even after repeated oral administration of doses of 5000 mg/kg bw/d in a subchronic oral toxicity study, conducted with the read-across substance Tetradecyl 2-hydroxypropionate (CAS 1323-03-1).
Furthermore, no adverse effects were observed in two acute dermal toxicity studies with Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters, and with the read-across substance Alcohols, C12-13-branched and linear (CAS 75782-86-4, former CAS 67762-41-8), resulting in dermal LD50 values > 2000 mg/kg bw.
No information is available for acute inhalation toxicity of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters.
The available data indicate a very low level of acute toxicity for Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters and thus no hazard for acute oral and dermal toxicity was identified.
Justification for selection of acute toxicity – oral endpoint
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).
Justification for selection of acute toxicity – dermal endpoint
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).
Justification for classification or non-classification
The available data on the acute oral and dermal toxicity of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
There are no data available on acute inhalation toxicity.
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.