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EC number: 271-685-3 | CAS number: 68604-33-1 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid ammonium salt and SDA Reporting Number: 04-006-01.
- 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:
- 2018-02-07 to 2018-03-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 July 2010
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- updated 06 July 2012
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Fatty acids, C14-18 and C16-18-unsatd., ammonium salts
- EC Number:
- 271-685-3
- EC Name:
- Fatty acids, C14-18 and C16-18-unsatd., ammonium salts
- Cas Number:
- 68604-33-1
- Molecular formula:
- C14H28O2.H3N / C16H32O2.H3N / C18H36O2.H3N / C18H34O2.H3N / C18H32O2.H3N / C18H30O2.H3N / C16H30O2.H3N .
- IUPAC Name:
- Fatty acids, C14-18 and C16-18-unsatd., ammonium salts
- Test material form:
- other: paste-like
- Details on test material:
- Identification: Fatty acids, C14-18 and C16-18-unsatd., ammonium salts.
Batch: 2017-30 2022-30 01.
Purity: 85.3% (contains 14.7% water).
Physical state, appearance: Yellow-brown paste.
Expiry Date: July 2022.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Test system: Mice, CBA/CaOlaHsd.
- Source: Mice, Envigo RMS B.V., Inc; Postbus 6174; 5960 AD Horst / The Netherlands.
- Number of animals for the pre-tests: 4 females (2 for each pre-test).
- Number of animals for the main study: 16 females.
- Number of animals per group: 4 females (nulliparous and non-pregnant).
- Number of test groups: 3 .
- Number of control (vehicle) groups: 1.
- Age (beginning of treatment): 1st pre-test: 10 - 11 weeks; 2nd pre-test: 11 - 12 weeks; Main study: 8 - 9 weeks.
- Body weight at study initiation: 1st pre-test: 20.7g and 19.2g; 2nd pre-test: 21.2g and 22.6g; Main study: 18.4g (#1), 16.4g(#2), 19.2g(#3), 18.1g(#4), 19.0g(#5), 18.9g(#6), 20.0g(#7), 20.0g(#8), 19.3g(#9), 18.5g(#10), 18.0g(#11), 17.7g(#12), 19.0g(#13), 17.0g(#14), 18.3g(#15) and 17.8g(#16).
- Identification: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
- Acclimation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
- Housing: group.
- Bedding: granulated soft wood bedding.
- Feed: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum.
- Water: tap water, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C.
- relative humidity approx. 45-65%.
- Photoperiod (hrs dark / hrs light): 12h/12h (artificial light 6.00 a.m. - 6.00 p.m.).
Study design: in vivo (LLNA)
- Vehicle:
- other: Ethanol/water (7+3 v/v). Ethanol: Purity: ≥99.9%; Water: Sterile.
- Concentration:
- 0% (Control Group); 2.5%(Low Dose); 5%(Mid Dose) and 10%(High Dose) [concentrations as determined in a pre-experiment].
- No. of animals per dose:
- 4
- Details on study design:
- Test Item Preparation:
1. Vehicle and Dose Selection:
A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which could be technically used was a 50% solution in ethanol/water (7+3, v/v). Vortexing was used to formulate the test item. At higher concentrations, an applicable formulation of the test item was not achieved, neither by the use of other vehicles nor by using additional methods to formulate the test item (e.g. vortexing, sonicating, warming to 37°C).
To determine the highest non-irritant test concentration that at the same time did not induce signs of systemic toxicity, a pre-test was performed in two animals and stated in raw data and report. Two mice were treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 25 and 50% once daily each on three consecutive days. Prior to the first application of the test item and before sacrifice the body weight was determined. Clinical signs were recorded at least once daily. Eventual signs of local irritation were documented and a score was used to grade a possible erythema of the ear skin. Furthermore, prior to the first application of the test item (day 1), on day 3 and before sacrifice (day 6) the ear thickness was determined using a micrometer. Additionally, for both animals, the ears were punched after sacrifice (day 6) at the apical area using a biopsy punch (Ø 8 mm corresponding to 0.5 cm2) and were immediately pooled per animal and weighed using an analytical balance. Eventual ear irritation was considered to be excessive if an erythema of the ear skin of a score value ≥3 was observed at any observation time and/or if an increase in ear thickness of ≥25% was recorded on day 3 or day 6.
At the tested concentrations the animals did not show any signs of systemic toxicity. The animals showed an erythema of the ear skin (Score 1 to 2). Additionally, the ears were visibly swollen, showed scaly skin and eschar formation. The animal treated with 50% test item concentration also showed slight erythema of the scalp and both animals had increased ear thickness and weight.
Therefore, a second pre-test was performed using test item concentrations of 5 and 10%. At the tested concentrations the animals did not show any signs of systemic toxicity. The animals showed an erythema of the ear skin (Score 1 to 2, see Appendix 1 for details). Additionally, the animal treated with 10% test item concentration showed scaly ears.
Thus, the test item in the main study was assayed at 2.5, 5, and 10%. The highest concentration tested was the highest level that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed in the pre-experiment.
2. Test Item Preparation:
The test item was placed into an appropriate container on a tared balance and ethanol/water (7+3, v/v) was added.
The different test item concentrations were prepared individually.
The preparations were made freshly before each dosing occasion.
Test Item Administration:
Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 2.5, 5, and 10% in ethanol/water (7+3, 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).
Administration of 3H-methyl-thymidine:
Five days after the first topical application (day 6) 250 µL of phosphate-buffered saline containing 21.2 µCi of 3H-methyl thymidine (equivalent to 84.8 µCi/mL 3HTdR) were injected into each test and control mouse via the tail vein.
Preparation of Single Cell Suspensions:
The draining lymph nodes were rapidly excised and pooled for each experimental group (8 nodes per group). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 µm mesh size). After washing two times with phosphate buffered saline (approx. 10 mL) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 mL) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules.
Determination of cellular proliferation (incorporation of 3HTdR):
The precipitates were then resuspended in 5 % trichloroacetic acid (1 mL) and transferred to scintillation vials with 10 mL of scintillation liquid and thoroughly mixed. The level of 3HTdR incorporation was then measured in a -scintillation counter. Similarly, background 3HTdR levels were also measured in two 1 mL aliquots of 5 % trichloroacetic acid. The -scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
Observations:
Clinical Observations: All animals were observed on a daily basis, including pre- and post-dose observations on days 1, 2 and 3. Any clinical signs of systemic toxicity, local skin irritation or signs of ill health during the study were recorded.
Determination of Ear Thickness: In the pre-test, the ear thickness was determined prior to the first application of the test item (day 1), on day 3, and on day 6 prior to sacrifice using a micrometer.
Determination of ear weights: In the pre-test, after the lymph nodes have been excised, both ears of mice were punched at the apical area using a biopsy punch (Ø 8 mm corresponding to 0.5 cm2). For each animal both punches were immediately weighed per animal using an analytical balance. The values obtained were taken down manually. The results are described in the report.
Determination of Body Weights: The body weights were recorded on day 1 (prior to dosing) and prior to sacrifice (pre-test) or prior to treatment with 3HTdR (main experiment)
Interpretation of raw data:
The proliferative response of the lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/lymph node) and as the ratio of 3HTdR incorporated into lymph node cells of test animals relative to that recorded for lymph nodes of control animals (Stimulation Index; S.I.). Before DPM/lymph node values were determined, mean scintillation-background DPM was subtracted from test and control raw data.
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.
General Calculations:
The mean values and standard deviations were calculated in the body weight tables.
Where appropriate, the EC3 value were calculated according to the equation
EC3 = (a-c) [(3-d)/(b-d)] + c
where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the S.I. value of 3 on the local lymph node assay dose response plot.
All calculations conducted on the DPM values were performed with a validated test script of “R”, a language and environment for statistical computing and graphics. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The periodic positive control experiment was performed using CBA/CaOlaHsd mice in October 2017.
Test item concentration 10%: S.I. 2.77; Test item concentration 25%: S.I. 5.70; EC3 = 11.2% (w/v).
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Test item concentration 0% (Group 1)
- Parameter:
- SI
- Value:
- 0.99
- Test group / Remarks:
- Test item concentration 2.5% (Group 2)
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- Test item concentration 5% (Group 3)
- Parameter:
- SI
- Value:
- 1.21
- Test group / Remarks:
- Test item concentration 10% (Group 4)
- Cellular proliferation data / Observations:
- Calculation of the EC3 value:
The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
Viability / Mortality:
No deaths occurred during the study period.
Clinical Signs:
No symptoms of local skin irritation at the ears of the animals and no signs of systemic toxicity were observed during the study period. From day 1 to 4, the animals treated with a test item concentration of 5 and 10% showed an erythema of the ear skin (Score 1, for details see Appendix 3). Animals treated with 2.5% test item concentration did not show any signs of local skin irritation.
Body Weights:
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.
Any other information on results incl. tables
Calculation and Results of Individual Data
Test item concentration % |
Group | Measurement DPM |
Calculation | Result | ||
DPM-BG a) | number of lymph nodes |
DPM per lymph node b) |
S.I. | |||
--- | BG I | 13 | --- | --- | --- | --- |
--- | BG II | 16 | --- | --- | --- | --- |
0 | 1 | 4759 | 4744.5 | 8 | 593.1 | 1 |
2.5 | 2 | 4735 | 4720.5 | 8 | 590.1 | 0.99 |
5 | 3 | 3808 | 3793.5 | 8 | 474.2 | 0.8 |
10 | 4 | 5764 | 5749.5 | 8 | 718.7 | 1.21 |
Vehicle: ethanol/water (7+3, v/v)
1 = Control Group; 2-4 = Test Group.
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
Pre-Test 1: Body Weights:
Animal No. |
Concentration % |
Body Weight (g) | |||
prior 1st Application |
prior to Sacrifice (Day 6) |
Difference Day 1 to Day 6 |
Difference % |
||
1 | 25 | 20.7 | 22.1 | 1.4 | 6.8 |
2 | 50 | 19.2 | 19.4 | 0.2 | 1.0 |
Pre-Test 1: Ear Thickness:
Animal No. |
Conc. % |
Ear Thickness | ||||||||
prior to 1st Application (µm) |
prior to 3rd Application (µm) |
prior to Necropsy (µm) |
||||||||
Right Ear |
Left Ear |
Mean | Right Ear |
Left Ear |
Mean | Right Ear |
Left Ear |
Mean | ||
1 | 25 | 240 | 225 | 232.5 | 275 | 270 | 272.5 | 390 | 410 | 400 |
2 | 50 | 240 | 230 | 235 | 305 | 290 | 297.5 | 410 | 390 | 400 |
Animal No. |
Difference Day 1 to Day 3 (µm) |
Ear Swelling Day 3 (%) |
Difference Day 1 to Day 6 (µm) |
Ear Swelling Day 6 (%) |
1 | 40 | 17.2 | 167.5 | 70 |
2 | 62.5 | 26.6 | 165 | 70.2 |
Pre-Test 1: Ear Weights:
Animal No. |
Concentration % |
Ear Weights after Necropsy (mg per animal) |
% Increase Compared to Vehicle Values |
1 | 25 | 41 | 56.5 |
2 | 50 | 41 | 56.5 |
Mean of historical controls (ethanol/water (7+3, v/v)): 26.2 mg/ animal)
Pre-Test 1: Ear Erythema:
Animal No. |
Score | |||||||
within 1 h after 1. appl. |
24 h after 1. appl. |
within 1 h after 2. appl. |
24 h after 2. appl. |
within 1 h after 3. appl. |
24 h after 3. appl. |
Day 5 | Day 6 | |
1 | / | 1 | 1 | 1 | 2 | 1° | 1° | /*°# |
2 | 1 | 1 | 2 | 2*°+ | 2*°+ | 1° | 1° | /*°# |
*visible swelling of ears °scaly ears +slight erythema of scalp #strong eschar formation
Score: / = No visible erythema; 1 = Very slight erythema; 2 = Well defined erythema; 3 = Moderate to severe erythema; 4 = Severe erythema to formation of eschar which prevents grading of erythema.
Pre-Test 2: Body Weights:
Animal No. |
Concentration % |
Body Weight (g) | |||
prior 1st Application |
prior to Sacrifice (Day 6) |
Difference Day 1 to Day 6 |
Difference % |
||
1 | 5 | 21.2 | 21.3 | 0.1 | 0.5 |
2 | 10 | 22.6 | 22 | -0.6 | -2.7 |
Pre-Test 2: Ear Thickness:
Animal No. |
Conc. % |
Ear Thickness | ||||||||
prior to 1st Application (µm) |
prior to 3rd Application (µm) |
prior to Necropsy (µm) |
||||||||
Right Ear |
Left Ear |
Mean | Right Ear |
Left Ear |
Mean | Right Ear |
Left Ear |
Mean | ||
1 | 5 | 230 | 240 | 235.0 | 240 | 240 | 240.0 | 240 | 245 | 242.5 |
2 | 10 | 230 | 230 | 230.0 | 240 | 235 | 237.5 | 235 | 235 | 235.0 |
Animal No. |
Difference Day 1 to Day 3 (µm) |
Ear Swelling Day 3 (%) |
Difference Day 1 to Day 6 (µm) |
Ear Swelling Day 6 (%) |
1 | 5 | 2.1 | 7.5 | 3.2 |
2 | 7.5 | 3.3 | 5 | 2.2 |
Pre-Test 2: Ear Weights:
Animal No. |
Concentration % |
Ear Weights after Necropsy (mg per animal) |
% Increase Compared to Vehicle Values |
1 | 5 | 27.71 | 5.8 |
2 | 10 | 29.48 | 12.5 |
Mean of historical controls (ethanol/water (7+3, v/v)): 26.2 mg/ animal)
Pre-Test 2: Ear Erythema:
Animal No. |
Score | |||||||
within 1 h after 1. appl. |
24 h after 1. appl. |
within 1 h after 2. appl. |
24 h after 2. appl. |
within 1 h after 3. appl. |
24 h after 3. appl. |
Day 5 | Day 6 | |
1 | 1 | / | 1 | 1 | 2 | 1 | / | / |
2 | 1 | / | 1 | 1* | 2 | 1* | /* | /* |
*scaly ears
Score: / = No visible erythema; 1 = Very slight erythema; 2 = Well defined erythema; 3 = Moderate to severe erythema; 4 = Severe erythema to formation of eschar which prevents grading of erythema.
Body Weights in the Main Experiment: Individual animal weights at the start of the experiment:
Dose Group | Animal no. |
Initial Weight (g) |
Mean SD | Range |
Negative Control EtOH 70% |
1 | 18.4 | 18.0 +/- 1.2 | 19.2 - 16.4 |
2 | 16.4 | |||
3 | 19.2 | |||
4 | 18.1 | |||
Test item Dose: 2,5% |
5 | 19.0 | 19.5 +/- 0.6 | 20.0 - 18.9 |
6 | 18.9 | |||
7 | 20.0 | |||
8 | 20.0 | |||
Test item Dose: 5% |
9 | 19.3 | 18.4 +/- 0.7 | 19.3 - 17.7 |
10 | 18.5 | |||
11 | 18.0 | |||
12 | 17.7 | |||
Test item Dose: 10% |
13 | 19.0 | 18.0 +/- 0.8 | 19.0 - 17.0 |
14 | 17.0 | |||
15 | 18.3 | |||
16 | 17.8 | |||
Summary | 18.5 +/- 1.0 | 16.4 - 20.0 |
Body Weights in the Main Experiment: Individual animal weights prior administration of 3H-methyl thymidine:
Dose Group | Animal no. |
Initial Weight (g) |
Mean SD | Range |
Negative Control EtOH 70% |
1 | 18.4 | 17.8 +/- 1.0 | 18.6 - 16.4 |
2 | 16.4 | |||
3 | 18.6 | |||
4 | 17.9 | |||
Test item Dose: 2,5% |
5 | 18.8 | 19.5 +/- 0.9 | 20.7 - 18.8 |
6 | 18.9 | |||
7 | 20.7 | |||
8 | 19.6 | |||
Test item Dose: 5% |
9 | 19.0 | 18.5 +/- 0.4 | 19.0 - 18.2 |
10 | 18.3 | |||
11 | 18.2 | |||
12 | 18.4 | |||
Test item Dose: 10% |
13 | 19.0 | 18.4 +/- 0.6 | 19.0 - 17.6 |
14 | 17.6 | |||
15 | 18.3 | |||
16 | 18.6 | |||
Summary | 18.5 +/- 0.9 | 16.4 - 20.7 |
Observations in the Main Experiment: Ear Erythema:
Animal No. |
Score | ||||||||
Within 1 h prior to 1. appl. (day 1) |
Within 1 h after 1. appl. (day 1) |
24 h after 1. appl. (day 2) |
Within 1 h after 2. appl. (day 2) |
24 h after 2. appl. (day 3) |
Within 1 h after 3. appl. (day 3) |
24 h after 3. appl. (day 4) |
Day 5 | Day 6 | |
1 | / | / | / | / | / | / | / | / | / |
2 | / | / | / | / | / | / | / | / | / |
3 | / | / | / | / | / | / | / | / | / |
4 | / | / | / | / | / | / | / | / | / |
5 | / | / | / | / | / | / | / | / | / |
6 | / | / | / | / | / | / | / | / | / |
7 | / | / | / | / | / | / | / | / | / |
8 | / | / | / | / | / | / | / | / | / |
9 | / | 1 | / | / | / | 1 | / | / | / |
10 | / | 1 | / | / | / | 1 | / | / | / |
11 | / | 1 | / | / | / | 1 | / | / | / |
12 | / | 1 | / | / | / | 1 | / | / | / |
13 | / | 1 | 1 | 1 | 1 | 1 | 1 | / | / |
14 | / | 1 | 1 | 1 | 1 | 1 | 1 | / | / |
15 | / | 1 | 1 | 1 | 1 | 1 | 1 | / | / |
16 | / | 1 | 1 | 1 | 1 | 1 | 1 | / | / |
Score: / = No visible erythema; 1 = Very slight erythema; 2 = Well defined erythema; 3 = Moderate to severe erythema; 4 = Severe erythema to formation of eschar which prevents grading of erythema.
Results of the GLP Positive Control:
Experiment performed in October 2017 (Envigo study number 1868000). Positive control substance: α-Hexylcinnamaldehyde:
Test item concentration % |
Group | Measurement DPM |
Calculation | Result | ||
DPM-BG a) | number of lymph nodes |
DPM per lymph node b) |
S.I. | |||
--- | BG I | 14 | --- | --- | --- | --- |
--- | BG II | 20 | --- | --- | --- | --- |
0 | 1 | 8827 | 8810 | 8 | 1101.2 | 1.00 |
5 | 2 | 9403 | 9386 | 8 | 1173.2 | 1.07 |
10 | 3 | 24442 | 24425 | 8 | 3053.1 | 2.77 |
25 | 4 | 50225 | 50208 | 8 | 6276 | 5.70 |
Vehicle: acetone:olive oil (4+1, v/v)
1 = Control Group; 2-4 = Test Group.
a) = The value was taken from the figure BG
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Fatty acids, C14-18 and C16-18-unsatd., ammonium salts was not a skin sensitiser under the test conditions of this study.
The substance "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts" is not considered to be classified for skin sensitisation. - Executive summary:
In the study the test item Fatty acids, C14-18 and C16-18-unsatd., ammonium salts formulated in ethanol/water (7+3, v/v) was assessed for its possible skin sensitising potential.
For this purpose a local lymph node assay was performed using test item concentrations of 2.5, 5, and 10%. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by two pre-experiments.
The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. From day 1 to 4, the animals treated witha test item concentration of5 and 10% showed an erythema of the ear skin (Score 1, for details see Appendix 3). Animals treated with 2.5% test item concentration did not show any signs of local skin irritation.
In this study Stimulation Indices (S.I.) of 0.99, 0.80, and 1.21 were determined with the test item at concentrations of 2.5, 5, and 10% in ethanol/water (7+3, v/v), respectively.
The test item Fatty acids, C14-18 and C16-18-unsatd., ammonium salts was not a skin sensitiser under the test conditions of this study.
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