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EC number: 218-076-0 | CAS number: 2049-95-8
- 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 (OECD 429,Reliability 1, GLP): sensitizing, Cat.1B, H317.
- Respiratory sensitisation: na data available.
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:
- From 01 June to 11 September 2017.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP 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: Charles River France, L'Arbresle Cedex, France.
- Age at study initiation: Approx. 10 weeks.
- Weight at study initiation: 20 - 26 g
- Housing: Individual houding in labeled Macrolon cages containing sterilized sawdust as bedding material.
- Diet (e.g. ad libitum): Free access to pelleted rodent food.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days before the start of the treatment under the laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3°C.
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours darkness.
IN-LIFE DATES: From: 20 June 2007 To: 09 July 2007. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0% (vehicle), 25%, 50%, 100%.
- No. of animals per dose:
- Five animals per dose.
- Details on study design:
- - RANGE FINDING TESTS: In the preliminary test, two animals were tested and each animal was treated with a test substance concentration of 50% or 100% on three consecutive days. No irritation was observed in any of the animals examined.
MAIN STUDY
- ANIMAL ASSIGNMENT AND TREATMENT: Indicate name of test method used. Comment on criteria used to consider a positive response.
- TREATMENT PREPARATION AND ADMINISTRATION: The dorsal surface of both ears was epidermally treated with 25 μl of the test substance concentration. The application was repeated on days 2 and 3). On day 6 an injection of 250 μl phosphate buffered saline (PBS) containing 20 μCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Five hours later, the draining Auricular lymph node of each ear was excised into PBS. A single cell suspension of lymph node cells was prepared from each mouse in PBS by gentle separation through stainless steel gauze. LNC were washed twice with an excess of PBS by centrifugation at 200g for 10 minutes at 4°C. Cells were precipitated with 5% trichloroacetic acid at 4 °C for 18 hours. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A Stimulation Index (SI) is calculated for each group. The SI is the ratio of the DPM/group compared to DPM/vehicle control group. The EC3 value (the estimated test substance concentration that will give a SI = 3) was determined using linear interpolation.
- Positive control results:
- The six monthly reliability check with Hexylcinnamaldehyde, indicates that the LLNA as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 25 %
- Remarks on result:
- other: see Remark
- Remarks:
- The SI values calculated for the Tertiary-amylbenzene concentrations of 25, 50 and 100% were 1.4, 4.0 and 4.9, respectively. These resutls indicate that the test substance could elicit and SI > 3. The data showed a dose-response and and EC3 value of 40% was calculated. All nodes of the experimental and control groups were considered normal in size.
- Key result
- Parameter:
- SI
- Value:
- 4
- Test group / Remarks:
- 50%
- Remarks on result:
- other:
- Remarks:
- The SI values calculated for the Tertiary-amylbenzene concentrations of 25, 50 and 100% were 1.4, 4.0 and 4.9, respectively. These resutls indicate that the test substance could elicit and SI > 3. The data showed a dose-response and and EC3 value of 40% was calculated. All nodes of the experimental and control groups were considered normal in size.
- Key result
- Parameter:
- SI
- Value:
- 4.9
- Test group / Remarks:
- 100%
- Remarks on result:
- other:
- Remarks:
- The SI values calculated for the Tertiary-amylbenzene concentrations of 25, 50 and 100% were 1.4, 4.0 and 4.9, respectively. These resutls indicate that the test substance could elicit and SI > 3. The data showed a dose-response and and EC3 value of 40% was calculated. All nodes of the experimental and control groups were considered normal in size.
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/Aminal values for the experimental groups treated with Tertiary-amylbenzene concentrations 25, 50 and 100% were 441, 1284 and 1561, respectively. The mean DPM/aminal value for the vehicle control group was 3190
- Key result
- Parameter:
- EC3
- Value:
- ca. 40
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the test conditions of this study, the test item Tertiary-amylbenzene induced delayed contact hypersensitivity in the murine Local Lymph Node Assay (EC3 value of 40%). Therefore, Tertiary-amylbenzene is classified into Category 1B, H317 according to EU criteria.
- Executive summary:
In a dermal sensitization study (Notox, 2007) with Tertiary-amylbenzene in acetone/olive oil (4/1), young adults CBA female mice (5 per group), were tested using the method of LLNA (OECD 429, GLP).
The test item was soluble in the first recommended vehicle, acetone/olive oil (4/1, v/v). A solution was obtained at the maximum tested concentration of 100%. Consequently, the concentrations selected for the main study were 0, 25, 50 and 100%.
No skin reactions were observed in any of the animals examined. All nodes of the experimental and control groups were considered normal in size.
Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 441, 1284 and 1561 respectively. The mean DPM/animal value for the vehicle control group was 319.
The SI values calculated for the substance concentrations 25, 50 and 100% were 1.4, 4.0 and 4.9 respectively. These results indicate that the test substance could elicit an SI >= 3. The data showed a dose response and an EC3 value of 40% was calculated.
Under the experimental conditions of this study, the test item Tertiary-amylbenzene induced delayed contact hypersensitivity in the murine Local Lymph Node Assay. According to the results obtained in this study, the test item should be classified as sensitizing to the skin, into category 1B, H317 according to EU criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitisation:
One study was available and considered as a key study. In a dermal sensitization study (Notox, 2007) with Tertiary-amylbenzene in acetone/olive oil (4/1), young adults CBA female mice (5 per group), were tested using the method of LLNA (OECD 429, GLP). The SI values calculated for the substance concentrations 25, 50 and 100% were 1.4, 4.0 and 4.9 respectively. These results indicate that the test substance could elicit an SI >= 3. The data showed a dose response and an EC3 value of 40% was calculated. Under the experimental conditions of this study, Tertiary-amylbenzene induced delayed contact hypersensitivity in the murine Local Lymph Node Assay.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
Not classified.
Self-classification:
1- Skin sensitisation: the SI values calculated for the substance concentrations 25, 50 and 100% were 1.4, 4.0 and 4.9 respectively. These results indicate that the test substance could elicit an SI >= 3 and an EC3 value of 40% was calculated (OECD 429, GLP, Reliability 1). Therefore, the test substance is considered as skin sensitizer and classified into category 1B, H317 according to EU criteria.
2- Respiratory sensitisation: no classification is possible due to lack of data.
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