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EC number: 939-066-9 | 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
Key study: OECD Guideline 429. GLP study. The test substance was determined to be not skin sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 26, 2012 - October 25, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, 33178 Borchen, Germany
- Age at study initiation: 8 – 9 weeks
- Weight at study initiation: 17-23 g
- Housing: Groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark - Vehicle:
- dimethyl sulphoxide
- Concentration:
- 100, 25 and 12.5% (diluted with DMSO, v/v)
- No. of animals per dose:
- 5 mice per dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The maximum technically applicable concentration of the test item in the vehicle was found to be 25% in DMSO.
- Irritation: Four animals were treated by topical application with the test item on three consecutive days at 100, 25 and 0% test item in DMSO. Neither signs of systemic toxicity nor signs of irritation at the application site could be detected in any animal.
- Lymph node proliferation response: No assessed on the prescreen test. Ear thickness measurements were performed on day 1 (pre-dose), day 3 (approximately 48 hours after the first dose) and day 6.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: A substance is regarded as a 'sensitizer' in the LLNA if at least one concentration of the test item results in a 3-fold or greater increase in 3H-methyl thymidine - incorporation into lymph node cells of the test group animals, relative to that recorded for the lymph nodes of control group animals (Stimulation Index equal to or greater than 3.0).
TREATMENT PREPARATION AND ADMINISTRATION:
Each mouse was treated by topical application of 25 μL of the selected solution to the entire dorsal surface of each ear. Topical applications were performed once daily over three consecutive days.
Five days after the first application, 3H-methyl thymidine by intravenous injection was administered. 5 hours later, mice were sacrificed, the draining auricular lymph nodes excised and the pooled cell suspension prepared.
The 3H-methyl thymidine – incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM). Similarly, background 3H-methyl thymidine levels were also measured (5% TCA). Determination of radioactivity was performed individually for each animal. - Positive control substance(s):
- other: P-Phenylenediamine (CAS 106-50-3) - Historical data
- Positive control results:
- The laboratory conducts LLNA assay regularly and has an established historical positive-control database based on the substance p-Phenylenediamine for which reproducible and accureate positive results were obtained, and therefore, the substance is suitable as a positive control.
The recent reliability check was performed in October 2012. The raw data of this study are kept in the BSL archives. Stimulation index for 1% positive control on three consecutive days was 9.6 ± 3.3. - Key result
- Parameter:
- SI
- Remarks:
- (12.5% conc.)
- Value:
- 0.9
- Remarks on result:
- other: The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
- Key result
- Parameter:
- SI
- Remarks:
- (25% conc.)
- Value:
- 0.7
- Remarks on result:
- other: The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
- Key result
- Parameter:
- SI
- Remarks:
- (100% conc.)
- Value:
- 0.6
- Remarks on result:
- other: The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Fatty acids, C16-18 (even numbered), ammonium salts was determined to be not skin sensitising under test conditions in the LLNA assay since none of the three tested concentrations reached the stimulation index of 3.
- Executive summary:
A Local Lymph Node Assay (LLNA) was performed on test item Fatty acids, C16 -18 (even numbered), ammonium salt in accordance with OECD Guideline 429. Based on the results of the prescreen test the test item was assessed for sensitising properties at concentrations of 12.5% (v/v), 25% (v/v) each diluted with DMSO (v/v) and 100% (undiluted test item). 5 female CBA mice per dose were treated by topical application of 25 μL of the selected solution to the entire dorsal surface of each ear. Topical applications were performed once daily over three consecutive days. The 3H-methyl thymidine - incorporation into lymph node cells of the test group animals relative to the control goup animals were measure (Stimulation index). At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality was observed. None of the three tested concentrations of the test item reached the stimulation index of 3 and the EC3 value (derived by linear interpolation) could not be calculated. The test substance Fatty acids, C16 -18 (even numbered), ammonium salt was determined to be not skin sensitising.
Reference
Radioactive Determination of the Test Substance Groups:
|
CPM |
TEST ITEM |
CONC. [%] |
DPM |
DPM mean back ground |
DPM/NODE |
SI |
MV |
1332.6 |
Negative control DMSO |
|
2730.8 |
2708.2 |
1354.1 |
1.0 |
SD |
445.1 |
911.1 |
911.1 |
455.5 |
|
||
MV |
1332.6 |
Test ítem in DMSO |
12.5 |
2553.0 |
2530.4 |
1265.5 |
0.9 |
SD |
445.1 |
140.0 |
140.0 |
70.0 |
0.1 |
||
MV |
1332.6 |
Test ítem in DMSO |
25.0 |
1991.6 |
1969.0 |
984.5 |
0.7 |
SD |
445.1 |
408.7 |
408.7 |
204.3 |
0.2 |
||
MV |
1332.6 |
Test ítem |
100 |
1684.8 |
1662.2 |
831.1 |
0.6 |
SD |
445.1 |
311.3 |
311.1 |
155.7 |
0.1 |
||
MV |
1332.6 |
Background Szinti and TCA |
|
22.6 |
0.0 |
0.0 |
0.0 |
SD |
445.1 |
1.9 |
|
|
|
CPM = counts per minute; Conc. = concentration; DPM = disintegrations per minute; SD = standard deviation; MV = mean value; Szinti = scintillation fluid; TCA = trichloroacetic acid
All animals survived throughout the test period without showing any clinical signs.
All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Key study: A Local Lymph Node Assay (LLNA) was performed on test item Fatty acids, C16 -18 (even numbered), ammonium salt in accordance with OECD Guideline 429 (GLP study). Based on the results of the prescreen test the test item was assessed for sensitising properties at concentrations up to 100% (undiluted test item, 25 µL) in female mice. Animals did not show any visible clinical symptoms and no case of mortality was observed. None of the three tested concentrations of the test item reached the stimulation index of 3 and the EC3 value (derived by linear interpolation) could not be calculated. The test substance was determined to be not skin sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, the test substance Fatty acids, C16 -18 (even numbered), ammonium salts is not classified as skin sensitizer according to CLP Regulation (EC) No 1272/2008.
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