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EC number: 255-350-9 | CAS number: 41395-83-9
- 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 (Read-across, OECD 407, rat) NOAEL: ≥ 2500 mg/kg bw/day
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- Read across short term and subchronic oral toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- rat, 28d
- Effect level:
- >= 2 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
- Remarks on result:
- other:
- Remarks:
- Source CAS 85883-73-4
- Key result
- Critical effects observed:
- no
- Conclusions:
- The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their repeated dose toxicity potential. The oral repeated dose toxicity of the target substance is estimated based on adequate and reliable short-term toxicity studies with structural analogue source substances. In a 28-day oral gavage study (OECD guideline 407) in male and female rats with the source substance Fatty acids, C6-12, esters with propylene glycol (CAS 85583-73-4) the NOAEL was found to be greater than 2500 mg/kg/day (highest dose tested). In a 90-day oral gavage study (OECD guideline 408) in male and female rats with the source substance Decanoic acids, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) the NOAEL was found to be greater than 1000 mg/kg/day (highest dose tested). Therefore, a NOAEL for repeated dose toxicity after oral exposure of 2500 mg/kg bw/day is considered for the target substance Propylene dinonanoate (CAS 41395-83-9).
Reference
Data from the source substance Fatty acids, C6-12, esters with propylene glycol (CAS 85883-73-4) was selected as key results for reasons of structural similarity and data reliability.
Additional data from sub-chronic (90-day) oral toxicity testing is given for the source substance Decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7. No adverse toxic effects were seen in this study at doses up to 1000 mg/kg bw/day. The systemic NOAEL was found to be≥1000 mg/kg bw/day in male and female rats.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The available information comprises adequate and reliable (Klimisch score 2) studies from reference substances with a common mode of action. Read-across is justified based on different compounds having the same type of effect(s) as described in scenario 2 of the Read-Across Assessment Framework (Read-Across Assessment Framework (RAAF), European Chemicals Agency, Helsinki, Finland, 2017), (please refer to the Analogue Justification for further details provided in IUCLID section 13).The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Repeated dose toxicity, oral
CAS 85883-73-4 A 28-day sub-acute repeated oral dose toxicity study was conducted according to OECD guideline 407 under GLP conditions (key study, 2006) with Fatty acids, C6-12, esters with propylene glycol (CAS 85583-73-4). Ten rats/sex/dose were administered 0 (water control), 500, 1500, and 2500 mg/kg bw/day 7 days per week by oral gavage over 28 days. No treatment related adverse effects were observed regarding clinical signs, mortality, feed consumption, body weight, haematology, clinical chemistry, urine analysis, opthalmoscopic examination, gross pathology, organ weights and histopathology examinations. The NOAEL for sub-acute (28-day) systemic toxicity for male and female rats was 2500 mg/kg bw/day.
CAS 68583-51-7
A 90-day sub-chronic repeated oral dose toxicity study was conducted according to OECD guideline 408 and under GLP conditions (supporting study, 1993) with Decanoic acids, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7). 10 rats/sex/dose and 5 satellite control and high dose rats/sex were administered 0 (vehicle control), 100, 300, 1000 mg/kg bw/day 5 days per week by oral gavage over 90 days.
Rats were observed daily for clinical abnormalities. The body weight, and feed and water consumption were measured weekly; while haematology and clinical chemistry were assessed in week 6 and week 13. Opthalmoscopic examination, gross pathology, histopathology examinations were performed, and organ weights were determined after sacrifice at study termination. One female at 100 mg/kg bw/day died at the last investigation and blood collection; one male at 300 mg/kg bw/day died in week 7 at the intermediate investigation and blood collection and 1 female at 300 mg/kg bw/day died at the last investigation and blood collection. 1 female and 1 male at 1000 mg/kg bw/day died at the last investigation and blood collection. No substance-related mortality was observed and no toxicologically relevant effects were observed. Based on the absence of adverse toxic effects, the NOAEL for sub-chronic (90-day) systemic toxicity for male and female Wistar rats was 1000 mg/kg bw/day.
Overall conclusion for repeated dose toxicity
The data for the read-across analogue substance showed that no effects were observed up to and including the recommended limit values. Therefore, as the available data did not identify any hazard for repeated dose toxicity, Propylene dinonanoate (CAS 41395-83-9) is not considered to be hazardous following repeated exposure.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Propylene dinonanoate (CAS 41395-83-9), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the analogue read-across approach, the available data on repeated dose toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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