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EC number: 271-668-0 | CAS number: 68603-62-3
- 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 1); OECD 429; (Dreher 2017)
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:
- 24 March - 17 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in accordacen 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- 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: 15-25 ºC, protected from light
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in acetone: olive oil 80:20 v/v
- 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: Dissolved in acetone: olive oil 80:20 v/v
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: Test item dose solutions prepared at 50, 25, 10 % in acetone: olive oil 80:20 v/v
- Final preparation of a solid: N/A
FORM AS APPLIED IN THE TEST (if different from that of starting material) : Applied as a liquid
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) : N/A
OTHER SPECIFICS: N/A - Species:
- mouse
- Strain:
- other: CBA/CaCrl
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Margate, UK
- Females (if applicable) nulliparous and non-pregnant: Yes
- Microbiological status of animals, when known: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 18-23 g, individual weight body weights were within ±20 % of the mean
- Housing: The animals were housed in groups of up to five during acclimatisation in period in suspended, solid floor cages with wire lids. From Day-1, the preliminary study animal was individually housed and the main study animals were housed in groups of up to three. Bedding was provided on a weekly basis to each cage by use of clean European softwood bedding (Datesand Ltd., Manchester, UK). The bedding had been analysed for specific contaminants and the results retained on file at Covance. No contaminants were present in bedding at levels which might have interfered with achieving the objective of the study.
- Diet (e.g. ad libitum): 5LF2 EU Rodent Diet 14%, was freely available to the animals at all times. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer. No contaminants were present in diet at levels which might have interfered with achieving the objective of the study. Results are retained on file at Covance.
- Water (e.g. ad libitum): Mains water was provided, ad libitum, via cage-mounted water bottles. The water had been periodically analysed for specific contaminants. No contaminants were present in water at levels which might have interfered with achieving the objective of the study. Results are retained on file at Covance.
- Acclimation period: 22 days
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 ºC
- Humidity (%): 45-65 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12:12 light:dark
- IN-LIFE DATES: From: 28 March 2017 To: 25 April 2017 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25, 50 % w/v
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: Soluble in vehicle at 50 % w/v
- Irritation: Very slight (barely perceptible) erythema was noted from Day 2 to Day 6 and there was no change in ear thickness.
- Systemic toxicity: No evidence of systemic evidence
- Ear thickness measurements: No change in ear thickness
- Erythema scores: 0 (Day 1) and 1 (Day 2 through 6)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Mouse Local Lymph Node Assay
- Criteria used to consider a positive response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per animal and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non sensitizer".
TREATMENT PREPARATION AND ADMINISTRATION:
Formulations were freshly prepared as required using 80% v/v acetone in olive oil on Days 1, 2 and 3. The formulations were stored at room temperature in sealed, air- tight containers prior to dosing and were used within two hours of preparation. The formulations were mixed by multiple inversion of the containers prior to administration to ensure homogeneity.
Concentrations of test article were expressed gravimetrically and in terms of test article received (without regard to purity or active content).
The five groups of five female mice were subjected to application of the vehicle control, positive control or one of the test formulations to the outer aspect of the auditory pinnae, once daily on Days 1, 2 and 3. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The positive control article produced a Stimulation Index of 17.27 (positive indication)
- Key result
- Parameter:
- SI
- Value:
- 17.22
- Test group / Remarks:
- 10 % w/v
- Key result
- Parameter:
- SI
- Value:
- 24
- Test group / Remarks:
- 25 % w/v
- Key result
- Parameter:
- SI
- Value:
- 25.16
- Test group / Remarks:
- 50 % w/v
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Not reported
DETAILS ON STIMULATION INDEX CALCULATION
The scintillation counter provided data including the DPM value (disintegrations per minute during a ten minute period) for each individual animal. The mean DPM value for each test group was divided by the mean DPM for the control group to provide the Stimulation Index (SI) value for each test group.
EC3 CALCULATION
Not determined.
CLINICAL OBSERVATIONS:
There were no clinical signs indicative of a systemic effect of treatment among mice treated with the vehicle or with 10, 25 or 50 % w/v formulations of the test article. Very slight erythema was noted on the backs of the ears of all animals treated at 50 % w/v from Day 2 to Day 6 and in animals treated at 25 % w/v from Day 3 to Day 6. No irritation was noted in the vehicle control group, the positive control group or in animals treated at 10 % w/v. Greasy fur to the neck and back of ears was noted in all test groups and the positive control group from Day 2 to Day 6.
BODY WEIGHTS
There was no indication of a treatment related effect on body weight. - Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test article was classified as a Category 1 sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
OECD 429 (2017) - In a dermal sensitization study with Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) in acetone: olive oil (4:1 v/v) young female adult mice (CBA/CaCrl) were tested using the Local Lymph Node Assay (LLNA)
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 50 %, this concentration was selected as the highest dose investigated in the main test. Three groups, each of five animals, were treated with 25 μL of the test item in solution in the vehicle at concentrations of 50, 25 and 10 % w/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 at a concentration of 25 % v/v in the vehicle.
There were no signs of systemic toxicity through the test period. Local skin irritation observed was limited to grade 1 erythema i.e. very slight erythema (barely perceptible) and ear thickness were within normal range. There were no clinical abnormalities or macroscopic abnormalities of the surrounding area were noted for any of the animals and no mortality reported during the study. 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.
The test item did elicit a Stimulation Index ≥ 3 when tested at ≥ 10 % w/v with SI values of 17.22, 24.00 and 25.16 in the 10, 25 and 50 % w/v test groups, respectively. The test item was therefore considered to be a sensitiser under the conditions of the test.
In this study, Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) was a dermal sensitiser.
Based on the condition of this study, the test item was classified as a Category 1 sensitiser according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
Reference
Table 1 Stimulation index results
Test Group |
Animal # |
Individual animal DPM |
Mean group DPM (std. dev.) |
Stimulation index (SI)a |
Solvent control (acetone: olive oil 4:1 v/v) |
104 |
475 |
283 (130.8) |
N/A |
105 |
107 |
|||
106 |
271 |
|||
107 |
265 |
|||
108 |
295 |
|||
10 % test item |
109 |
4926 |
4866 (1785.6) |
17.22 |
110 |
6888 |
|||
111 |
1979 |
|||
112 |
5236 |
|||
113 |
5301 |
|||
25 % test item |
114 |
7923 |
6783 (843.2) |
24.00 |
115 |
5721 |
|||
116 |
6807 |
|||
117 |
7184 |
|||
118 |
6278 |
|||
50 % test item |
119 |
6074 |
7112 (711.8) |
25.16 |
120 |
7955 |
|||
121 |
7516 |
|||
122 |
6844 |
|||
123 |
7169 |
|||
Positive control |
124 |
5672 |
4881 (1034.7) |
17.27 |
125 |
5500 |
|||
126 |
4320 |
|||
127 |
5597 |
|||
128 |
3317 |
aStimulation Index (SI) of ≥ 3.0 indicates a positive result
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
OECD 429 (2017) - In a dermal sensitisation study with Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) in acetone: olive oil (4:1 v/v) young female adult mice (CBA/CaCrl) were tested using the Local Lymph Node Assay (LLNA)
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 50 %, this concentration was selected as the highest dose investigated in the main test. Three groups, each of five animals, were treated with 25 μL of the test item in solution in the vehicle at concentrations of 50, 25 and 10 % w/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 at a concentration of 25 % v/v in the vehicle.
There were no signs of systemic toxicity through the test period. Local skin irritation observed was limited to grade 1 erythema i.e. very slight erythema (barely perceptible) and ear thickness measured during the preliminary screening test was within normal range. There were no clinical abnormalities or macroscopic abnormalities of the surrounding area were noted for any of the animals and no mortality reported during the study. 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.
The test item did elicit a Stimulation Index ≥ 3 when tested at ≥ 10 % w/v with SI values of 17.22, 24.00 and 25.16 in the 10, 25 and 50 % w/v test groups, respectively. The test item was therefore considered to be a sensitiser under the conditions of the test.
In this study, Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) was a dermal sensitiser.
Based on the condition of this study, the test item was classified as a Category 1 sensitiser according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance meets the criteria for classification as a category 1 skin sensitiser in accordance with Regulation (EC) No 1272/2008 (CLP).
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