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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
Skin sensitisation (Read-across, LLNA, OECD 429): not sensitising
Skin sensitisation (Read-across, GPMT, OECD 406): not sensitising
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
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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
- Parameter:
- SI
- Value:
- 0.98
- Variability:
- cells counted per group
- Test group / Remarks:
- 25% test substance
- Key result
- Parameter:
- SI
- Value:
- 1.02
- Variability:
- cells counted per group
- Test group / Remarks:
- 50% test substance
- Key result
- Parameter:
- SI
- Value:
- 1.32
- Variability:
- cells counted per group
- Test group / Remarks:
- 100% test substance
- Key result
- Parameter:
- SI
- Value:
- 1.13
- Variability:
- cells counted per group
- Test group / Remarks:
- 5% positive control substance
- Key result
- Parameter:
- SI
- Value:
- 1.48
- Variability:
- cells counted per group
- Test group / Remarks:
- 10% positive control substance
- Key result
- Parameter:
- SI
- Value:
- 2.19
- Variability:
- cells counted per group
- Test group / Remarks:
- 25% positive control substance
- Key result
- Parameter:
- other: EC1.4 [%]
- Value:
- 8.86
- Variability:
- cells were counted per group (n=4 mice)
- Test group / Remarks:
- positive control substance
- Remarks on result:
- other: EC1.4 was treshold in this study
- Key result
- Parameter:
- other: EC1.4 [%]
- Variability:
- cells were counted per group (n=4 mice)
- Test group / Remarks:
- test substance
- Remarks on result:
- not determinable
- Remarks:
- as all SI values were < 1.4
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their skin sensitisation potential. In a LLNA assay with C8-10 Fatty acids, vegetable-oil, esters with dipropylene glycol (CAS 95009-41-9) no indication for sensitisation was found. In a guinea pig maximisation test with Dodecanoic acid, ester with 1,2-propandiol (CAS 37321-62-3) no skin sensitising potential was found. Therefore, no skin sensitisation potential is expected for the target substance Propylene dinonanoate (CAS 41395-83-9).
Reference
Data from the source substance Fatty acids, vegetable-oil, esters with dipropylene glycol (CAS 95009-41-9) was selected as key results for reasons of structural similarity and data reliability.
Additional data from an guinea pig maximisation test is given for the source substance 1,2-Propandiol-mono/di-dodecanoate (CAS 37321-62-3). No indication of skin sensitisation was observed after topical challenge treatment at 100% (highest non-irritant concentration) for 24 hours under occlusive conditions. Skin reactions were evaluated 24 and 48 hours after the end of challenge exposure; none of the test animals and none of the control animals showed a skin reaction at the 48 and 72 hour post application readings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
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.
Skin sensitisation
CAS 95009-41-9
A LLNA assay was performed according to OECD guideline 429 under GLP conditions with C8-C10 Fatty acids, vegetable-oil, esters with dipropylene glycol (CAS 95009-41-9) in mice (key study, 2014). Groups of 4 mice were treated by topical applications to the dorsal surface of the ears for three consecutive days with 50 μL (25 μL per ear) of the test item at 0% (vehicle control), 25%, 50% and 100%. On day 6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by cell counting. No mortality and no signs of systemic toxicity were noted in the test and control animals during the test. No skin irritation was recorded at any of the concentrations used during the test. No significant increase in ear thickness and in ear weight was noted in animals treated at 25%, 50% and 100%. The Stimulation Index (SI) was 0.98, 1.02 and 1.32 for the treated groups at 25%, 50% and 100%, respectively. The Stimulation Index (SI) was 1.13, 1.48 and 2.19 for the positive control groups at 5%, 10% and 25% hexyl cinnamic aldehyde, respectively. For interpretation of the results a cut-off value of EC 1.4 was used, which had been validated in the laboratory as alternative endpoint value instead of EC3. For the test groups no EC1.4 could be calculated as all SI values were < 1.4. Under the conditions of the study, the test item was not considered as skin sensitising.
CAS 37321-62-3
A Guinea pig maximisation study was performed with Dodecanoic acid, ester with 1,2-propandiol (CAS 37321-62-3) according to OECD guideline 406 and under GLP conditions (supporting study, 1992). 19 test and 10 control Dunkin Hartley guinea pigs were induced on Day 0 intradermally with 10% of the test substance in corn oil with and without Freud's complete adjuvant. One hour after injection of FCA all test and control animals showed severe erythema and oedema. 11/20 test animals and 6/20 control animals showed injuries in the depth. 24 hours later all animals showed severe erythema and oedema. 24 hours after test substance injection all test animals showed slight erythema and oedema comparable to the control animals. Injection of test substance and FCA (1:1) induced moderate to strong erythema and moderate oedema. After 24 hours strong erythema with deep injuries in 8/20 test animals and strong oedema were observed. Control animals injected with 50% FCA and corn oil showed 1 hour after application well defined erythema and slight oedema. 24 hours post application severe erythema with deep injuries (3/20) and strong oedema were observed. On Day 6, the animals were treated with 10% sodium dodecyl sulfate to induce mild skin irritation. On Day 7, a 48-hour epicutaneous induction treatment with the undiluted test substance was done under occlusive conditions. One animal died within 24 hours after the dermal induction. Possibly, the animal was too strong bandaged resulting in dyspnoea and death. Necropsy revealed a clear yellow liquid in the thorax and no further abnormal organ findings. On Day 21, the challenge treatment was performed by topical application of the test substance at 100% (highest non-irritant concentration) to all animals for 24 hours, under occlusive conditions. Skin reactions were evaluated 24 and 48 hours after the end of challenge exposure; none of the test animals and none of the control animals showed a skin reaction at the 48 and 72 hour post application readings. No positive control group was included. Based on the study conditions, the test substance had no sensitising effect in guinea pigs.
Overall conclusion for skin sensitisation
No sensitising potential was seen in experimental studies in mice and guinea pigs performed with analogue source substances. Based on the available information, Propylene dinonanoate (41395-83-9) is not expected to be skin sensitising.
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 (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 skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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.
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