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EC number: 214-222-2 | CAS number: 1115-20-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline conform GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate
- EC Number:
- 214-222-2
- EC Name:
- 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate
- Cas Number:
- 1115-20-4
- Molecular formula:
- C10H20O4
- IUPAC Name:
- 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate
- Details on test material:
- Name of test substance: Hydroxypivalic acid neopentylglycol ester flakes
CAS No.: 1115-20-4
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Test system / strain / quality: Mouse / CBA/J
- Age on day 0: 8 – 12 weeks
- Sex: Female
- Supplier: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Acclimatization period: 14 days before the first test-substance application
- Body weight on day 0: 17.4 g – 21.5 g
- Housing: single in Makrolon cage, type II
- Diet (e.g. ad libitum): Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12 h /12 h
- Bedding: Lignocel PS14; SSNIFF
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 50 % ; The 50% preparation was the maximum technically applicable concentration. The study was carried out as a limit test, using 1 test group and 1 control group.
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A solubility experiment was performed according to the recommendations given by OECD 429. The highest test-substance concentration, which can be technically used, was a 50% test-substance preparation.
- Irritation: none
- Lymph node proliferation response: none
MAIN STUDY
The study was carried out as a limit test, using 1 test group and 1 control group. Each test animal was applied with 25 μL per ear of the test-substance preparation to the dorsum of both ears for three consecutive days. The control group was treated with 25 μL per ear of the vehicle alone.
Three days after the last application the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μL of sterile saline into a tail vein. About 5 hours after the 3H-thymidine injection, the mice were sacrificed and the auricular lymph nodes were removed. The weights of each animal’s pooled lymph nodes were determined. Thereafter lymph nodes were pooled group wise and further evaluated by measuring their cellular content and 3H-thymidine incorporation into the lymph node cells (indicators of cell proliferation). Moreover, a defined area with a diameter of 0.8 cm was punched out of the apical part of each ear and for each test group the weight of the pooled punches was determined in order to obtain an indication of possible skin irritation.
The stimulation indices (fold of change as compared to the vehicle control) for cell count, 3H-thymidine incorporation, lymph node weight and ear weight were measured. The increase SI of cell count by a factor of ≥ 1.5 and/or of 3H-thymidine incorporation by a factor of ≥ 3 as compared to the concurrent vehicle control group is generally considered as indicating a sensitizing potential of a test substance. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- mean velues, and standard diviation
Results and discussion
- Positive control results:
- A concurrent positive control (reliability check) with a known sensitizer was not included into this study. Studies using the positive control substance Alpha-Hexylcinnamaldehyde, techn. 85% are performed twice a year in the laboratory in order to show that the test system is able to detect sensitizing compounds under the test conditions chosen. Positive controls in these experiments gave the expected results.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.83
- Remarks on result:
- other: 0.83 (compared to the concurrent control) 2 .04 (compared to the historical control)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: vehicle propylene glycol 1,380.9 (SI =1); historical control (mean value) 561.2 50% test substance in propylne glycol: 1,143.3
Any other information on results incl. tables
CELL COUNT, 3H-THYMIDINE INCORPORATION AND LYMPH NODE WEIGHT:
TEST GROUP MEAN VALUES AND STIMULATION INDICES
Test group |
Treatment |
Cell Counts |
|
|
|
[Counts/Lymph Node Pair] |
Stimulation Index |
1 |
vehicle propylene glycol historical control (mean) |
8 634 667 6 809 867 |
1.00 |
2 |
50% in propylene glycol |
7 776 000 |
0.90 1.14 |
Test group |
Treatment |
³H-thymidine incorporation |
|
|
|
[DPM/Lymph Node Pair] |
Stimulation Index |
1 |
vehicle propylene glycol historical control (mean) |
1 380.9 561.2 |
1.00 |
2 |
50% in propylene glycol |
1 143.3 |
0.83 2.04 |
Test group |
Treatment |
Lymph Node Weight
|
|
|
|
[mg/Lymph Node Pair] |
Stimulation Index |
1 |
vehicle propylene glycol |
5.4 |
1.00 |
2 |
50% in propylene glycol |
4.8 |
0.90 |
EAR WEIGHT: TEST GROUP MEAN VALUES AND STIMULATION INDICES
Test group |
Treatment |
Ear weight |
|
|
|
[mg/animal] |
Stimulation Index |
1 |
vehicle propylene glycol |
32.3 |
1.00 |
2 |
50% in propylene glycol |
34.5 |
1.06 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
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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