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EC number: 946-056-8 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Sep - 05 Oct 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 23 Jul 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Health Care Inspectorate of the Ministry of Health, Welfare and Sport, Utrecht, The Netherlands
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Hexanedioic acid, di-C16-18-alkyl esters
- EC Number:
- 296-703-7
- EC Name:
- Hexanedioic acid, di-C16-18-alkyl esters
- Cas Number:
- 92969-90-9
- Molecular formula:
- not applicable, substance is UVCB
- IUPAC Name:
- Hexanedioic acid, di-C16-18 (even numbered)-alkyl esters
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Remarks:
- SPF quality
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Approximately 10 weeks
- Weight at study initiation: 17.5 - 21.5 g (Group 1); 20.8 - 22.7 g (Group 2); 19.5 - 23.3 g (Group 3); 22.0 - 26.3 g (Group 4)
- Housing: 5 females per group were housed in labeled Makrolon Cages (MIII type; height 18 cm) containing sterilised sawdust as bedding material. Paper and shelters were supplied as cage-enrichment.
- Diet: SM R/M-Z, pelleted rodent diet (SSNIFF Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
- Indication of any skin lesions: Animals were healthy and the ears were intact and free from any abnormality.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10, 25 and 50% (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS: 2 female mice per concentration were treated by daily application of a 50% in dimethylformamide or undiluted test substance to the dorsal surface of the ear, for 3 consecutive days. Very slight erythema (Grade 1) and/or scaliness were noted for the animals treated with the undiluted test substance between Days 2 - 6. Hunched posture and/or piloerection were observed for the animals treated with the undiluted test substance on Days 2 and 3. With a 50% test substance concentration no signs of systemic toxicity were noted and no erythema were observed, but scaliness was noted for one animal between Days 4 and 6.
- Irritation: The animals were observed for local skin irritation to the application site once daily on Day 1 (pre-dose) to Day 6 (prior to necropsy). On Days 1-3 observation was performed within 1 h after dosing.
- Systemic toxicity: The animals were observed for mortality twice daily. The body weight was recorded on Day 1 prior to dosing and on Day 6. Signs of toxicity were recorded on Days 1-6 (on Days 1-3 between 3-4 h after dosing).
- Ear thickness measurements: Ear thickness measurements of both ears were performed using a digital thickness gauge prior to dosing on Days 1 and 3, and on Day 6.
- Erythema scores: Draize scoring system
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: ³H-methyl thymidine incorporation determined by β-scintillation and γ-counting
- Criteria used to consider a positive response: DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group using the individual SI values. The individual SI is the ratio of the DPM/animal compared with the DPM/vehicle control group mean. If the results indicate a SI ≥ 3, the test item is regarded as a skin sensitizer.
- Other: The animals were observed for mortality twice daily. The body weight was recorded on Day 1 prior to dosing and on Day 6. Signs of toxicity were recorded on Days 1-6 (on Days 1-3 between 3-4 h after dosing).
TREATMENT PREPARATION AND ADMINISTRATION:
25 µL of the test material was applied to the entire dorsal surface of each ear of each mouse on Day 1, 2 and 3 in concentrations of 10, 25 and 50% in dimethylformamide. The local irritation effects on the treatment site were assessed daily. On Day 6 an injection of 250 µL phosphate buffered saline (PBS) containing 20 µCi of ³H-methyl thymidine (³H-TdR) was made into the tail vein of each mouse. Five hours later, the draining auricular lymph node of each ear was excised into PBS and pooled per group. A single cell suspension of pooled lymph node cells was prepared by gentle separation through a 200-mesh stainless steel gauze and rinsed with PBS. The precipitates were incubated in the refrigerator until the next day, centrifuged, resuspended in 1 mL trichloroacetic acid and transferred to 10 mL scintillation fluid before β-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- For both scientific and animal welfare reasons, no concurrent positive control group was included in the study. An extensive data base is available with reliability checks performed at half-yearly intervals during at least the past 9 years, showing reproducible and consistent positive results with hexyl cinnamic aldehyde. The SI values calculated for the positive control concentrations 5, 10 and 25% were 1.4, 1.5 and 4.3, respectively. An EC3 value of 18.0% was calculated using linear interpolation (Test facility study number: 513924, May 2016).
Based on the results, the positive control was considered to demonstrate the appropriate performance of the assay, with adequate and reproducible sensitivity to a known sensitising test substance.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 10% (w/w)
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 25% (w/w)
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 50% (w/w)
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION: The SI of the 10, 25 and 50% treatment group was 0.9, 1.1 and 1.4, respectively. None of the test substance concentrations produced as 3-fold increase in ³HTdR incorporation.
EC3 CALCULATION: None of the SI values were above 3 and it is therefore not possible to determine a EC3 concentration.
CLINICAL OBSERVATIONS: No mortality occured and no signs of systemic toxicity were observed in any of the animals. Very slight erythema (Grade 1) was observed in 3/5 females treated with a 50% test substance concentration (w/w) on Day 2, 3 and 4, respectively.
BODY WEIGHTS: The body weights and body weight gain remained with the same range as controls during the study period.
Any other information on results incl. tables
Table 1: Irritation scores and clinical signs of toxicity recorded in the pre-screen test
Test substance concentration | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | ||||||
left | right | left | right | left | right | left | right | left | right | left | right | |
50% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0 | 0 | 0 | 0 | 0 | 0 | 0 S | 0 | 0 S | 0 | 0 S | 0 | |
100% | 0 | 0 | 0 H | 1 | 1 HP | 1 | 0 S | 0 | 0 S | 0 | 0 S | 0 S |
0 | 0 | 0 HP | 0 | 1 HP | 1 | 0 S | 0 S | 0 S | 0 S | 0 S | 0 S |
H: Hunched posture
P: Piloerection
S: Scaliness
0: no erythema; 1: very slight erythema
Table 2: Results of the main test
Test substance | DPM/animal | mean DPM± SEM | mean SI ± SEM |
Solvent control | 1256 | 748± 205 | 1.0± 0.4 |
74 | |||
537 | |||
1020 | |||
851 | |||
10% | 668 | 704± 48 | 0.9± 0.3 |
809 | |||
573 | |||
647 | |||
822 | |||
25% | 845 | 790 ± 57 | 1.1± 0.3 |
905 | |||
88 | |||
619 | |||
694 | |||
50% | 871 | 1070 ± 225 | 1.4± 0.5 |
879 | |||
490 | |||
1809 | |||
1302 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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