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Diss Factsheets
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EC number: 942-066-1 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 19 Feb 2013 - 12 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study, for read-across justification refer to IUCLID section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Hexanedioic acid, bis(2-propylheptyl) ester-
- IUPAC Name:
- Hexanedioic acid, bis(2-propylheptyl) ester-
- Reference substance name:
- XPB 115
- IUPAC Name:
- XPB 115
- Test material form:
- other: liquid
- Details on test material:
- Please refer to confidential details on test material
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., AD Horst/Netherlands
- Age at study initiation: pre-test: 10 - 11 weeks (beginning of treatment); Main study: 9 - 10 weeks (beginning of treatment)
- Weight at study initiation: 20.7 +/- 0.9 g
- Housing: Makrolon Type II (pre-test) / III (main study), with wire mesh top; group housing; granulated soft wood bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 45 - 65%
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: 27 Feb 2013 To: 12 March 2013
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0% (control); 10, 25 and 50% in acetone/olive oil (4:1 v/v)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: On day 3 the animal treated with 100% test item concentration showed an erythema of the ear skin (Score 1), increase in ear weight > 25%
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled: First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the Stimulation Index. Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
The preparations were made freshly before each dosing occasion. The different test item concentrations were prepared individually. Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 10, 25, and 50% in acetone:olive oil (4+1, v/v). The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (∅ ∼ 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone (control animals). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables, for the ear weights, the lymph node weights and lymph node cell count, and for the DPM values (group mean DPM ± standard deviation).
A statistical analysis was conducted on the DPM values, the ear weights, the lymph node weights and the lymph node cell count to assess whether the difference was statistically significant between the test item groups and negative control group. For all statistical calculations SigmaStat for Windows (Version 2.0) was used. A One-Way-Analysis-of-Variance was used as a statistical method. In case of significant results of the One-Way-ANOVA, multiple comparisons were performed with the Dunnett test. Statistical significance was set at the five per cent level (p < 0.05).
Results and discussion
- Positive control results:
- The periodic positive control experiment with α-Hexylcinnamaldehyde in acetone:olive oil (4+1 v/v) was performed using CBA/CaOlaHsd mice in October 2012. At the concentration of 25 %, an increase in cellularity and a stimulation index exceeding the threshold value of 3 (SI = 5.7) were noted. The study was therefore considered valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Control Group: 1.00 Test Group (10 %): 0.84 Test Group (25 %): 2.08 Test Group (50 %): 3.70 Positive control group (25 % HCA): 5.7
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean dpm per animal (2 lymph nodes): Control Group: 358.6 +/- 146.2 dpm Test Group (10 %): 301.0 +/- 96.2 dpm Test Group (25 %): 745.2 +/- 183.5 dpm Test Group (50 %): 1327.2 +/- 638.0 dpm Positive control group (25 % HCA): 3430.0 dpm
Any other information on results incl. tables
No deaths occurred during the study period.
No signs of systemic toxicity were observed during the study period.
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
A statistically significant increase in ear weights was not observed in any treated group in comparison to the vehicle control group. Furthermore, for BALB/c mice, a cutoff-value of 1.1 for the ear weight index was reported for a positive response regarding ear skin irritation. The index determined for the high dose group of 1.12 reached this threshold, indicating a marginal borderline positive response for ear skin irritation. But the index obtained did not exceed the threshold of 1.25 for excessive irritation stated in the OECD.
A statistically significant and biological relevant increase in lymph node weight was observed in the high dose group.
For the lymph node cell count, a statistically significant and biologically relevant increase was observed in the mid and high dose group in comparison to the vehicle control group. Furthermore, the cutoff-value of 1.55 for a positive response regarding the lymph node cell count index reported for BALB/c mice was exceeded in the high dose group (index of 1.8).
Applicant's summary and conclusion
- Interpretation of results:
- other: weakly sensitizing
- Remarks:
- Criteria used for interpretation of results: EU
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