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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 948-383-1 | CAS number: -
- 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
LLNA (OECD 429): not sensitising (read-across)
GPMT (OECD 406): not sensitising (read-across)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Source: CAS 11138-60-6
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Source: CAS 11138-60-6
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 11138-60-6
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 11138-60-6
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 11138-60-6
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 11138-60-6
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 11138-60-6
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 11138-60-6
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance CAS 11138-60-6. In the guinea pig maximisation test, no skin sensitisation was observed. The read-across approach is justified in the analogue justification. The target and the source substance are considered unlikely to differ in their skin sensitising potential. The target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid is not expected to have a skin sensitising potential.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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
- Parameter:
- SI
- Test group / Remarks:
- 25%
- Remarks on result:
- not measured/tested
- Remarks:
- Source: CAS 95912-89-3
- Parameter:
- SI
- Test group / Remarks:
- 50%
- Remarks on result:
- not measured/tested
- Remarks:
- Source: CAS 95912-89-3
- Parameter:
- SI
- Test group / Remarks:
- 100%
- Remarks on result:
- not measured/tested
- Remarks:
- Source: CAS 95912-89-3
- Parameter:
- other: Lymph node cell count
- Value:
- 1.029
- Test group / Remarks:
- 25%
- Remarks on result:
- other: Source: CAS 95912-89-3
- Parameter:
- other: Lymph node cell count
- Value:
- 1.308
- Test group / Remarks:
- 50%
- Remarks on result:
- other: Source: CAS 95912-89-3
- Parameter:
- other: Lymph node cell count
- Value:
- 1.212
- Test group / Remarks:
- 100%
- Remarks on result:
- other: Source: CAS 95912-89-3
- Parameter:
- other: Lymph node weight
- Value:
- 0.962
- Test group / Remarks:
- 25%
- Remarks on result:
- other: Source: CAS 95912-89-3
- Parameter:
- other: Lymph node weight (g)
- Value:
- 1.173
- Test group / Remarks:
- 50%
- Remarks on result:
- other: Source: CAS 95912-89-3
- Parameter:
- other: Lymph node weight (g)
- Value:
- 1.135
- Test group / Remarks:
- 100%
- Remarks on result:
- other: Source: CAS 95912-89-3
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance CAS 95912-89-3. In the local lymph node assay, no skin sensitisation was observed. The read-across approach is justified in the analogue justification. The target and the source substance are considered unlikely to differ in their skin sensitising potential. The target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid is not expected to have a skin sensitising potential.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for read-across
Experimental data on skin sensitisation of Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid are not available. The assessment was therefore based on studies conducted with analogue source substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint, the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
CAS 95912-89-3
To assess the skin sensitisation potential of Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3), a modified LLNA in NMRI mice was performed according to OECD 429 and under the conditions of GLP (Key, 2012). Based on a preliminary experiment in 3 animals, the undiluted test substance (100%) and dilutions of the test substance in acetone/olive oil (3+1 v/v) at concentrations of 25 and 50% (w/w) were tested in six female mice per group. During 3 consecutive days, the dorsal surface of both ears of each animal was epidermally treated once daily with the undiluted test substance and their respective dilutions (25 μL/ear). Two similar constituted groups were exposed to the vehicle and the positive control substance hexyl cinnamic aldehyde at a concentration of 25% in the vehicle, respectively. Before the first application of the test substance and at sacrifice (Day 4 of the study), skin irritation was assessed by measuring the ear thickness of the animals. In addition, punch biopsies of the apical area of both ears were prepared and weight for the determination of irritating effects. Furthermore, the draining (auricular) lymph node of each ear was excised and weighed for the assessment of skin sensitisation. Single cell suspensions of pooled lymph nodes from each individual animal per group were prepared and cell proliferation was measured by automatically counting the lymph node cells. Stimulation indices were calculated for the lymph node cell count, lymph node weight, ear weight and ear thickness by dividing the average values per group of the test item treated animals by the vehicle treated ones. Treatment with test substance at concentrations of 25%, 50% or 100% did not reveal statistically significantly increased values for lymph node cell count. The stimulation indices (SI) of the lymph node cell count of the test substance (1.029, 1.308 and 1.212 at 25, 50 and 100%, respectively) did not exceed the threshold level for a positive result (SI > 1.4). Since the threshold level for the SI of the ear weight was not exceeded (SI < 1.1) and no increase of ear thickness was observed, the test substance was not considered to show irritating properties. The positive control substance hexyl cinnamic aldehyde induced the expected increase in lymph node cell count (SI > 1.4) and lymph node weight (statistically significant at p ≤ 0.01), thereby verifying the validity of the study. No signs of local or systemic intolerance were recorded and the body weight of the animals was not affected by treatment. Under the present test conditions, the test substance at concentrations of 25% and 50% (w/w) in acetone/olive oil (3+1 v/v) and the undiluted test substance (100%) did not reveal any sensitising properties in the local lymph node assay. Based on the available data, Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane is not sensitising.
CAS 11138-60-6
A Guinea Pig Maximisation Test was performed with Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol (CAS 11138-60-6) according to OECD 406 under GLP conditions (Key, 1997). 20 male and female Dunkin-Harley guinea pigs were treated with the test substance and compared with 10 negative control animals (5 per sex). A 5% dilution of the test substance in propylene glycol was used for intradermal induction on the shoulder region on Day 1. 100% of the test item was used for topical induction on the shoulder region on Day 8. 14 days after the last induction treatment, all animals were challenged epicutaneously with the undiluted test substance. 24 hours after challenge, one out of twenty animals (5%) showed a skin reaction compared to 3 out of ten (30%) for the positive control. 48 hours after challenge none of the test animals showed any skin reactions. The sensitivity of the animal strain was tested confirmed using Hexylcinnamic aldehyde (HCA) as a positive control substance. Thus, the test substance is not considered to have skin sensitizing potential. In summary, Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol is not considered to have skin sensitising potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid 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) No. 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.
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.