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EC number: 283-393-3 | CAS number: 84608-82-2
- 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:
- 30 Aug - 12 Sep 2017
- 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 in 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Slovenska Narodna Akreditacna Sluzba, Bratislava, Slovak Republic
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate
- EC Number:
- 283-393-3
- EC Name:
- 2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate
- Cas Number:
- 84608-82-2
- Molecular formula:
- C26H45NO6
- IUPAC Name:
- 2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Velaz Prague, Czech Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: range: 18 - 22 g (prior to first treatment)
- Housing: 5 animals per cage in polypropylene cages suspended on stainless steel racks, on Lignocel S3/4 bedding (Lufa - ITL GmbH, Germany)
- Diet: ssniff (Ssniff Spezialdiäten GmbH, Germany), ad libitum
- Water: public tap water, ad libitum; analysis was performed
- Acclimation period: 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 24 Aug To: 12 Sep 2017
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- (AOO)
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
In the pre-screen test, 25 μL of the undiluted test item were applied to the dorsum of both ears of two animals, once a day for 3 consecutive days. Both animals were observed daily for clinical signs. The body weights were recorded prior to dosing and on the day of necropsy. Furthermore, the treated skin area was scored for erythema daily and ear thickness was measured on Day 1 (pre-dose) and Day 3 and 6. No necropsy was performed on the animals.
- Compound solubility: The test item was soluble in the vehicle, for the concentration of 50%, a homogeneous solution was obtained.
- Irritation: No irritation was observed (i.e. an erythema score ≥ 3 or an ear thickness increase ≥ 25%).)
- Systemic toxicity: No signs of toxicity were observed.
- Ear thickness measurements: No relevant increase was induced by treatment.
- Erythema scores: No erythema was observed (scores = 0).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA test
- Criteria used to consider a positive response: A substance is regarded as sensitizer in the LLNA test if it induces a Stimulation Index (SI) ≥ 3.
TREATMENT PREPARATION AND ADMINISTRATION: Based on the lack of skin irritationsystemic toxicity and changes in the ear thickness in the pre-screen test, the test item was used at 25, 50 and 100% concentration in the main study. 25 μl of each dose formulation were applied to the dorsum of both ears of each animal once a day for 3 consecutive days. On Day 6, 250 µL of phosphate-buffered saline (PBS) containing 2 μCi (7.4 x 104 Bq) of 125 I-iododeoxyuridine and 10^-5 M fluorodeoxyuridine was injected into all test and control mice via the tail vein. 5 h later the local lymph nodes were collected from the sacrificed mice, then pooled and minced. The lymph node cells (LNC) were treated with 5% trichloroacetic acid (TCA) for 18 - 20 h before determination of the amount of 125 I-iododeoxyuridine incorporation (expressed as disintegrations per minute (DPM)/ animal, measured by the automatic Gamma Counter Wizard2 2470 (Perkin Elmer, USA). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- T-test (MS Excel) for body weight
Results and discussion
- Positive control results:
- The positive control substance (25% HCA) induced a positive reaction with a SI of 6.79. The control group demonstrates the validity of the study.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- mean of 5 animals
- Value:
- 1.76
- Test group / Remarks:
- 25% test group
- Key result
- Parameter:
- SI
- Remarks:
- mean of 5 animals
- Value:
- 5.43
- Test group / Remarks:
- 50% test group
- Key result
- Parameter:
- SI
- Remarks:
- mean of 5 animals
- Value:
- 4.77
- Test group / Remarks:
- 100% test group
- Key result
- Parameter:
- EC3
- Value:
- 33.5
- Test group / Remarks:
- test group
- Parameter:
- SI
- Remarks:
- mean of 5 animals
- Value:
- 6.79
- Test group / Remarks:
- positive control group
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
: An increase of the pooled lymph node weights was observed at all used concentrations, but without being dose dependent. Increased but not dose dependent lymphoproliferation (SI > 3) was observed at the test substance concentrations of 50% (SI =5.43) and 100% (SI = 4.77). At 25% of the test substance, only a slight increase in the lymphoproliferation was observed (SI = 1.76).
DETAILS ON STIMULATION INDEX CALCULATION : DPM = CPM/ absolute detector efficiency
DPM = desintegrations per minute
CPM = counts per minute
absolute detector efficiency (Gamma Counter Wizard2 2470) = 66.73%
SI = pooled DPM test group/ pooled DPM vehicle control group
EC3 CALCULATION : EC3 = c + [(3 - d)/ (b - d)] x (a - c)
a = higher concentration
b = SI of higher concentration
c = lower concentration
d = SI of lower concentration
An EC3 of 33.5% was obtained.
CLINICAL OBSERVATIONS: Neither mortality nor clinical signs were recorded in animals treated at all dose levels investigated.
BODY WEIGHTS: Minor, but not significant, increases in body weight were observed during the study.
Any other information on results incl. tables
Table 1: Mean Stimulation Indices in mice
|
Concentration |
Lymph node weight (of 10 lymph nodes) [g] |
DPM |
Stimulation index |
EC3 [%] |
Vehicle control (AOO) |
100 |
0.0347 |
1423 |
- |
33.5 |
Test substance |
25 |
0.0450 |
2503 |
1.76 |
|
50 |
0.0740 |
7724 |
5.43 |
||
100 |
0.0676 |
6785 |
3.1 |
||
Positive control (HCA) |
25 |
0.0619 |
9659 |
6.79 |
AOO = acetone/olive oil (4:1 v/v)
DPM = desintegrations per minute
HCA = α-Hexylcinnamaldehyde
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 1B (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Skin Sens. 1B
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