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EC number: 284-902-1 | CAS number: 84989-13-9
- 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
Skin Sensitisation: Sensitising (Category 1B); OECD 429; A. Poole. (2018).
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:
- 09 Jul - 15 Aug 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 22 July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (EC) No. 440/2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese MAFF
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: n/a
- Specific activity: n/a
- Locations of the label: n/a
- Expiration date of radiochemical substance: n/a
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark.
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: soluble in dimethyl formamide
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No
- Preliminary purification step (if any): No
- Final dilution of a dissolved solid, stock liquid or gel: No
- Final preparation of a solid: No
FORM AS APPLIED IN THE TEST (if different from that of starting material): n/a - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc., Horst, The Netherlands
- Females (if applicable) nulliparous and non-pregnant: Yes
- Microbiological status of animals, when known: Not reported
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 23 g
- Housing: The animals were housed in suspended solid floor polypropylene cages furnished with softwood woodflakes
- Diet (e.g. ad libitum): Free access to food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK)
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation period: At least 5 days
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): At least 15 changes/ hour
- Photoperiod (hrs dark / hrs light): 12 h: 12 h (light: dark)
- IN-LIFE DATES: Not reported - Vehicle:
- dimethylformamide
- Concentration:
- 5, 10 and 25 % (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: in vehicle
- Irritation: Yes
- Systemic toxicity: Yes
- Ear thickness measurements: Yes
- Erythema scores: Yes
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 2
- Criteria used to consider a positive response: a/a
TREATMENT PREPARATION AND ADMINISTRATION: The preliminary screening test suggested that the test item would not produce systemic toxicity or excessive local skin irritation at the highest suitable dose five mice were treated with the test item at , 5, 10 and 25 % (w/w) by daily application of 25 µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). control group received similar concentration of vehicle only or, α‑Hexylcinnamaldehyde.
Clinical Observations: twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6.
Body Weight: Recorded Day 1 (prior to dosing) and Day 6 (prior to termination).
Ear thickness and irritation: Measured on pre dose and post dose on Day 1, post dose on Days 2 and 3 and on Days 4 to 6. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate. Individual and group mean disintegrations per minute values were assessed for dose response relationships. Data was first assessed for suitability by analysis of normality and homogeneity of variance. If the assumptions that the data are both normally distributed and has homogeneity of variances, then parametric one way analysis of variance (ANOVA) and Dunnett’s multiple comparison procedure were used to determine statistical significance. If the assumptions were not met, non-parametric Kruskal-Wallis Rank Sum and Mann-Whitney U test procedures were used.
Probability values (p) are presented as follows:
P<0.001 ***
P<0.01 **
P<0.05 *
P>0.05 (not significant) - Positive control results:
- Concurrent control was within the historical control data. The positive control α-Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater than 3 (5.60) when tested at a concentration of 25% v/v in dimethyl formamide, thus, demonstrating the sensitivity and reliability of the test system.The test item was considered to be a sensitiser under the conditions of the test.
- Key result
- Parameter:
- SI
- Value:
- ca. 5.82
- Test group / Remarks:
- 25%
- Remarks on result:
- other: Sensitiser
- Key result
- Parameter:
- SI
- Value:
- ca. 3.7
- Test group / Remarks:
- 10%
- Remarks on result:
- other: Sensitiser
- Key result
- Parameter:
- SI
- Value:
- ca. 3.45
- Test group / Remarks:
- 5%
- Remarks on result:
- other: Sensitiser
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA: Refer to data tables.
DETAILS ON STIMULATION INDEX CALCULATION: Mean treatment group dpm / mean vehicle dpm
EC3 CALCULATION: Not applicable, all stimulation indices were >3 therefore no EC3 was caculable.
CLINICAL OBSERVATIONS: There were no deaths. No signs of systemic toxicity were noted in teh test or control animals during the test. Ear thickness measurements presented an increase of 6.075 %, 9.677 % and 18.349 % for the 5 %, 10 % and 25 % treatment group respectively, compared to 4.734 % in the vehicle control.
BODY WEIGHTS: Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period. - Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test item was considered to be a sensitiser (Category 1B) under the conditions of the test. Based on the condition of this study, the test item meet the criteria for classification according to the Globally Harmonized Classification System and Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
OECD 429 (2017) - In a dermal sensitisation study with the test item, Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., ammonium salts in dimethyl fromamide was evaluated young female adult mice (CBA/Ca (CBA/CaOlaHsd)) using the Local Lymph Node Assay (LLNA)
Following a preliminary screening test in which no clinical signs of toxicity were noted at the maximum concentration tested, this concentration was selected as the highest dose investigated in the main test. Three groups, each of five animals, were treated with 50 μL (25 μL per ear) of the undiluted test item or the test item as a solution in the vehicle at concentrations 5, 10 and 25 % v/v. A further group of five animals was treated with the vehicle alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitiser, α-Hexylcinnamaldehyde tech., 85%, at a concentration of 25 % v/v in the vehicle.
There were no deaths. No signs of systemic toxicity were noted in teh test or control animals during the test. Ear thickness measurements presented an increase of 6.075 %, 9.677 % and 18.349 % for the 5 %, 10 % and 25 % treatment group respectively, compared to 4.734 % in the vehicle control. Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period. The Stimulation Index, expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group, was determined for each treatment group.
There was indication that the test item elicits a Stimulation Index ≥ 3 when tested up to 25 %, the test item was considered to be a sensitiser under the conditions of the test.
In this study, Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., ammonium salts was considered a dermal sensitiser.
Based on the condition of this study, the test item met the criteria for classification as a sensitiser (category 1B) according to the Globally Harmonized Classification System and Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures
Reference
Individual Disintegrations per Minute and Stimulation Index during the Main Test
Treatment Group |
Animal Number |
dpm/ |
Mean dpm/Animal |
Stimulation Indexb |
Result |
Vehicle |
1-1 |
1577.94 |
1051.77 |
na |
na |
1-2 |
629.00 |
||||
1-3 |
902.72 |
||||
1-4 |
920.16 |
||||
1-5 |
1229.04 |
||||
Test Item |
2-1 |
2765.48 |
3625.53** |
3.45 |
Positive |
2-2 |
3944.71 |
||||
2-3 |
3411.77 |
||||
2-4 |
4400.00 |
||||
2-5 |
3605.67 |
||||
Test Item |
3-1 |
4416.16 |
3889.35** |
3.70 |
Positive |
3-2 |
2595.48 |
||||
3-3 |
3784.73 |
||||
3-4 |
3455.20 |
||||
3-5 |
5195.19 |
||||
Test Item |
4-1 |
5986.24 |
6124.84****** |
5.82 |
Positive |
4-2 |
6989.50 |
||||
4-3 |
4944.16 |
||||
4-4 |
6670.04 |
||||
4-5 |
6034.27 |
||||
Positive Control Item |
5-1 |
4995.44 |
5887.91*** |
5.60 |
Positive |
5-2 |
3011.45 |
||||
5-3 |
6088.73 |
||||
5-4 |
7770.11 |
||||
5-5 |
7573.81 |
dpm = Disintegrations per minute
a = Total number of lymph nodes per animal is 2
b = Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
*** = Significantly different from control group p<0.001
Measurement of Ear Thickness and Mean Ear Thickness Changes during teh Main Test
Treatment Group |
Animal Number |
Ear Thickness Measurement (mm) |
|||||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||||
pre‑dose |
post‑dose |
||||||||||||||
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
||
Vehicle |
1-1 |
0.20 |
0.21 |
0.21 |
0.21 |
0.20 |
0.23 |
0.22 |
0.22 |
0.23 |
0.21 |
0.22 |
0.21 |
0.20 |
0.22 |
1-2 |
0.21 |
0.20 |
0.20 |
0.20 |
0.20 |
0.21 |
0.21 |
0.23 |
0.21 |
0.22 |
0.22 |
0.22 |
0.22 |
0.21 |
|
1-3 |
0.23 |
0.20 |
0.23 |
0.21 |
0.22 |
0.21 |
0.21 |
0.22 |
0.21 |
0.22 |
0.21 |
0.21 |
0.23 |
0.23 |
|
1-4 |
0.22 |
0.21 |
0.22 |
0.21 |
0.21 |
0.22 |
0.22 |
0.22 |
0.22 |
0.22 |
0.21 |
0.22 |
0.22 |
0.22 |
|
1-5 |
0.22 |
0.20 |
0.20 |
0.21 |
0.22 |
0.20 |
0.23 |
0.21 |
0.23 |
0.22 |
0.23 |
0.21 |
0.22 |
0.22 |
|
overall mean (mm) |
0.211 |
0.210 |
0.211 |
0.219 |
0.219 |
0.216 |
0.221 |
||||||||
overall mean ear thickness change (%) |
Not applicable |
-0.592 |
0.000 |
3.550 |
3.550 |
2.367 |
4.734 |
||||||||
|
|||||||||||||||
Treatment Group |
Animal Number |
Ear Thickness Measurement (mm) |
|||||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||||
pre‑dose |
post‑dose |
||||||||||||||
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
||
Test Item |
2-1 |
0.23 |
0.23 |
0.23 |
0.23 |
0.20 |
0.23 |
0.21 |
0.22 |
0.22 |
0.22 |
0.22 |
0.23 |
0.23 |
0.24 |
2-2 |
0.22 |
0.21 |
0.22 |
0.22 |
0.20 |
0.22 |
0.20 |
0.20 |
0.22 |
0.21 |
0.21 |
0.23 |
0.23 |
0.21 |
|
2-3 |
0.23 |
0.20 |
0.22 |
0.21 |
0.22 |
0.22 |
0.21 |
0.22 |
0.21 |
0.23 |
0.22 |
0.23 |
0.25 |
0.24 |
|
2-4 |
0.20 |
0.22 |
0.20 |
0.22 |
0.20 |
0.22 |
0.21 |
0.22 |
0.22 |
0.22 |
0.22 |
0.22 |
0.22 |
0.20 |
|
2-5 |
0.20 |
0.20 |
0.20 |
0.22 |
0.19 |
0.21 |
0.20 |
0.21 |
0.21 |
0.21 |
0.21 |
0.21 |
0.22 |
0.23 |
|
overall mean (mm) |
0.214 |
0.217 |
0.211 |
0.210 |
0.217 |
0.220 |
0.227 |
||||||||
overall mean ear thickness change (%) |
Not applicable |
1.402 |
-1.402 |
-1.869 |
1.402 |
2.804 |
6.075 |
Treatment Group |
Animal Number |
Ear Thickness Measurement (mm) |
|||||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||||
pre‑dose |
post‑dose |
||||||||||||||
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
||
Test Item |
3-1 |
0.21 |
0.23 |
0.20 |
0.23 |
0.23 |
0.20 |
0.22 |
0.20 |
0.21 |
0.21 |
0.22 |
0.23 |
0.24 |
0.25 |
3-2 |
0.21 |
0.20 |
0.20 |
0.20 |
0.21 |
0.23 |
0.22 |
0.24 |
0.21 |
0.24 |
0.22 |
0.24 |
0.25 |
0.24 |
|
3-3 |
0.21 |
0.22 |
0.20 |
0.20 |
0.22 |
0.23 |
0.21 |
0.23 |
0.22 |
0.23 |
0.24 |
0.23 |
0.24 |
0.22 |
|
3-4 |
0.22 |
0.22 |
0.22 |
0.21 |
0.24 |
0.22 |
0.23 |
0.22 |
0.23 |
0.22 |
0.23 |
0.23 |
0.24 |
0.23 |
|
3-5 |
0.23 |
0.22 |
0.22 |
0.22 |
0.22 |
0.21 |
0.21 |
0.22 |
0.21 |
0.23 |
0.23 |
0.25 |
0.25 |
0.22 |
|
overall mean (mm) |
0.217 |
0.210 |
0.221 |
0.220 |
0.221 |
0.232 |
0.238 |
||||||||
overall mean ear thickness change (%) |
Not applicable |
-3.226 |
1.843 |
1.382 |
1.843 |
6.912 |
9.677 |
||||||||
|
|||||||||||||||
Treatment Group |
Animal Number |
Ear Thickness Measurement (mm) |
|||||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||||
pre‑dose |
post‑dose |
||||||||||||||
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
Right |
||
Test Item |
4-1 |
0.24 |
0.21 |
0.24 |
0.21 |
0.24 |
0.22 |
0.24 |
0.22 |
0.25 |
0.24 |
0.25 |
0.25 |
0.28 |
0.25 |
4-2 |
0.22 |
0.21 |
0.21 |
0.21 |
0.21 |
0.21 |
0.21 |
0.21 |
0.23 |
0.22 |
0.23 |
0.23 |
0.26 |
0.21 |
|
4-3 |
0.21 |
0.21 |
0.21 |
0.21 |
0.23 |
0.21 |
0.24 |
0.23 |
0.25 |
0.23 |
0.25 |
0.24 |
0.28 |
0.27 |
|
4-4 |
0.21 |
0.21 |
0.21 |
0.21 |
0.23 |
0.22 |
0.23 |
0.23 |
0.24 |
0.24 |
0.26 |
0.25 |
0.24 |
0.26 |
|
4-5 |
0.23 |
0.23 |
0.23 |
0.23 |
0.24 |
0.21 |
0.24 |
0.22 |
0.24 |
0.23 |
0.24 |
0.25 |
0.28 |
0.25 |
|
overall mean (mm) |
0.218 |
0.217 |
0.222 |
0.227 |
0.237 |
0.245 |
0.258 |
||||||||
overall mean ear thickness change (%) |
Not applicable |
-0.459 |
1.835 |
4.128 |
8.716 |
12.385 |
18.349 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
OECD 429 (2017) - In a dermal sensitisation study with the test item, Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., ammonium salts in dimethyl fromamide was evaluated young female adult mice (CBA/Ca (CBA/CaOlaHsd)) using the Local Lymph Node Assay (LLNA)
Following a preliminary screening test in which no clinical signs of toxicity were noted at the maximum concentration tested, this concentration was selected as the highest dose investigated in the main test. Three groups, each of five animals, were treated with 50 μL (25 μL per ear) of the undiluted test item or the test item as a solution in the vehicle at concentrations 5, 10 and 25 % v/v. A further group of five animals was treated with the vehicle alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitiser, α-Hexylcinnamaldehyde tech., 85%, at a concentration of 25 % v/v in the vehicle.
There were no deaths. No signs of systemic toxicity were noted in teh test or control animals during the test. Ear thickness measurements presented an increase of 6.075 %, 9.677 % and 18.349 % for the 5 %, 10 % and 25 % treatment group respectively, compared to 4.734 % in the vehicle control. Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period. The Stimulation Index, expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group, was determined for each treatment group.
There was indication that the test item elicits a Stimulation Index ≥ 3 when tested up to 25 %, the test item was considered to be a sensitiser under the conditions of the test.
In this study, Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., ammonium salts was considered a dermal sensitiser.
Based on the condition of this study, the test item met the criteria for classification as a sensitiser (category 1B) according to the Globally Harmonized Classification System and Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test item elicits a sensitisation index ≥ 3 in all three tested concentrations with SI of 5.82 observed at the highest concentration tested. Therefore, it met the criteria for classification as a sensitiser (category 1B) according to the Globally Harmonized Classification System and Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures
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