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EC number: 272-782-3 | CAS number: 68911-68-2
- 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:
- 15 February 2018 to 19 September 2018
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NouSan No. 8147, 24 November 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Amines, C12-14-tert-alkyl, compds. with 2(3H)-benzothiazolethione
- EC Number:
- 272-782-3
- EC Name:
- Amines, C12-14-tert-alkyl, compds. with 2(3H)-benzothiazolethione
- Cas Number:
- 68911-68-2
- Molecular formula:
- N/A
- IUPAC Name:
- C12-14-tert-alkylamines, compds. with 2(3H)-benzothiazolethione
- Test material form:
- liquid
1
- Specific details on test material used for the study:
- - CAS Number: 68911-68-2
- Purity: 99% (nominal); a substance of Unknown or Variable composition, Complex reaction products of biological materials (UVCB)
- Description: Dark Amber viscous liquid
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- The animals were housed in suspended solid floor polypropylene cages with stainless steel mesh lids and furnished with softwood flakes bedding (Datesand Ltd., Cheshire, UK).
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70%, respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 10, 25 and 50 % w/w
- No. of animals per dose:
- One mouse for the preliminary test, followed by five animals per dose in the main test.
- Details on study design:
- Preliminary Screening Test
A preliminary screening test was performed using one mouse, treated by daily application of 25 µL of the test item at a concentration of 50% w/w in acetone/olive oil 4:1, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed for local skin irritation, ear thickness, any clinical signs of toxicity and body weight.
Main Test
Test Item Administration
Groups of five mice were treated with the test item at concentrations of 50%, 25% or 10% w/w in acetone/olive oil 4:1. The preliminary screening test suggested that the test item would not produce systemic toxicity or excessive local skin irritation and that 50% was the highest suitable concentration, based upon the observation of slight yellow-coloured residual test item on the ears on the mice at that concentration.
The mice were treated 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). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of five mice received the vehicle alone in the same manner.
3H-Methyl Thymidine Administration
Five days following the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 3H methyl thymidine (3HTdR: 80 µCi/mL, specific activity 2.0 Ci/mmoL, ARC UK Ltd) giving a total of 20 µCi to each mouse.
Observations
- Clinical Observations: All animals were observed twice daily (pre- and post-dose) on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6 for any signs of toxicity or signs of ill health.
- Body Weights: The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).
Terminal Procedures
- Termination: Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation followed by cervical separation. For each individual animal of each group the draining auricular lymph nodes were excised and processed.
Preparation of Single Cell Suspension: A single cell suspension of the lymph node cells for each individual animal was prepared by gentle mechanical disaggregation. The lymph node cells were rinsed with PBS into a petri dish labeled with the study number and dose concentration. The lymph node cells suspension was transferred to a centrifuge tube and was pelleted at 1400 rpm (approximately 190 g) for 10 minutes. The pellet was re-suspended in PBS and re-pelleted. The pellet was re-suspended in 5% Trichloroacetic acid (TCA).
Determination of 3HTdR Incorporation: After approximately 18 hours incubation at approximately 4 ºC, the TCA precipitates were recovered by centrifugation and re-suspended in TCA and transferred to scintillation fluid. 3HTdR incorporation was measured by β-scintillation counting.
Data Evaluation
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 was 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 was classified as a "non sensitizer". - 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.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 8.65
- Test group / Remarks:
- 10% w/w in acetone/olive oil 4:1
- Key result
- Parameter:
- SI
- Value:
- 14.52
- Test group / Remarks:
- 25% w/w in acetone/olive oil 4:1
- Key result
- Parameter:
- SI
- Value:
- 18.85
- Test group / Remarks:
- 50% w/w in acetone/olive oil 4:1
- Key result
- Parameter:
- EC3
- Value:
- 4.1
Any other information on results incl. tables
Preliminary Screening Test
No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted. Based on this information, the dose levels selected for the main test were 50%, 25% and 10% v/v in acetone/olive oil 4:1.
Main Test
Estimation of the Proliferative Response of Lymph Node Cells
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (%v/v) in |
Stimulation Index |
Result |
10 |
8.65 |
Positive |
25 |
14.52 |
Positive |
50 |
18.85 |
Positive |
Clinical Observations
All animals survived to the schedule euthanasia; there were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Body Weight
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.
EC3 Value
The concentration of test item expected to cause a 3-fold increase in 3HTdR incorporation (EC3 value) was calculated to be 4.1% (extrapolated).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the conditions of the test, the test item is classified as a contact sensitizer (Category 1B) according to GHS, with an EC3 value of 4.1%.
- Executive summary:
A skin sensitisation study, local lymph node assay in the mouse (individual method) was performed in accordance to the standardized guidelines OECD 429 and EU Method B.42, under GLP conditions in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Following a preliminary screening test in a female mouse treated with test item at a concentration of 50% v/v in acetone/olive oil 4:1, in which no clinical signs of toxicity were noted, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of five female animals, were treated with 50 μL (25 μL per ear) of the test item, as a solution in acetone/olive oil 4:1, at concentrations of 50%, 25% or 10% v/v. A further group of five female animals was treated with acetone/olive oil 4:1 alone in the same manner.
Under the conditions of the test the test item is classified as a contact sensitizer (Category 1B) according to GHS, with an EC3 value of 4.1%.
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