Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 950-576-0 | CAS number: -
- 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:
- 17 Jul - 06 Aug 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (octan-2-yl)benzene
- EC Number:
- 950-576-0
- Cas Number:
- 31047-57-1
- Molecular formula:
- C14H22
- IUPAC Name:
- (octan-2-yl)benzene
- Test material form:
- liquid
- Details on test material:
- Identification: SHR 1396
Physical Description: Clear colorless liquid
Storage Conditions: At room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Females nulliparous and non-pregnant: yes.
- Microbiological status of animals: SPF-quality.
- Age at study initiation: 10 weeks old.
- Weight at study initiation: 19.6 to 23.0 grams.
- Housing: Animals were group housed (up to 5 animals of the same sex and same dosing group together) in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum.
- Water: Municipal tap-water was freely available to each animal via water bottles.
- Acclimation period: at least 5 days.
- Indication of any skin lesions: no.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The daily mean temperature during the study period was 22 to 23°C.
- Humidity (%): The daily mean relative humidity of 53 to 79%.
- Air changes (per hr): at least 10.
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From 17 Jul to 05 Aug.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- No. of animals per dose:
- 5 animals
- Details on study design:
- PRE-SCREEN TESTS:
Two test item concentrations were tested; a 50% (w/w) and 100% (w/w) concentration.
Two young adult females per concentration were selected. Each animal was treated with one concentration on three consecutive days. Ear thickness measurements were conducted using a digital thickness gauge (Kroeplin C110T-K) prior to dosing on Days 1 and 3, and on Day 6. Animals were sacrificed after the final observation.
MAIN STUDY
Three groups of five animals were treated with one test item concentration per group. The highest test item concentration was selected from the pre-screen test. One group of five animals was treated with the vehicle.
Group 1 was treated with the vehicle (vehicle control group). Group 2, 3 and 4 were treated with 25%, 50% and 100% concentration, respectively.
TREATMENT PREPARATION AND ADMINISTRATION:
Test item dosing formulations (w/w) were homogenized to visually acceptable levels at appropriate concentrations to meet dose level requirements.
The dosing formulations were prepared daily and dosed within 4 hours after adding the vehicle to the test item.
The dosing formulations were kept at room temperature until dosing.
The dosing formulations were stirred until and during dosing.
No adjustment was made for specific gravity of the vehicle and no correction was made for the purity/composition of the test item.
- Induction: Test item (25 μL) was applied in the dorsal surface of both ears of each animal, for 3 consecutive days.
- Excision of the Nodes. In day 6, each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS) containing 20 μCi of 3H-methyl thymidine. After five hours, all animals were euthanized by intraperitoneal injection (0.2 mL/animal) of Euthasol® 20%. The draining (auricular) lymph node of each ear was excised. The relative size of the nodes (as compared to normal) was estimated by visual examination and abnormalities of the nodes and surrounding area were recorded. The nodes were pooled for each animal in PBS.
- Tissue processing for radioactivity: On day 6 and following the excision of the nodes, a single cell suspension of limph node cells was prepared in PBS. LNC were washed twice and DNA was precipitated using 5% trichloroacetic acid (TCA).
- Radioactivity measurements: On day 7, precipitates were recovered by centrifugation, resuspended in 1 mL TCA and transferred to 10 mL of Ultima Gold cocktail as the scintillation fluid. Radioactivity measurements were performed using a Packard scintillation counter (2910TR). Counting time was to a statistical precision of ± 0.2% or a maximum of 5 minutes whichever came first. The scintillation counter was programmed to automatically subtract background and convert Counts Per Minute (CPM) to Disintegrations Per Minute (DPM).
ANALYSIS
DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group using the individual SI values. The individual SI is the ratio of the DPM/animal compared to the DPM/vehicle control group mean.
INTERPRETATION
If the results indicate a SI ≥ 3, the test item may be regarded as a skin sensitizer.
The results were evaluated according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of items and mixtures, including all amendments.
Consideration was given to the EC3 value (the estimated test item concentration that will give a SI =3) (see table 1 in 'any other information on material and methods')
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.9
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 2.4
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 2.5
- Test group / Remarks:
- 100%
- Cellular proliferation data / Observations:
- PRE-SCREENING TEST:
- At a 50% and 100% test item concentration, no signs of systemic toxicity were noted and up to very slight erythema was observed and therefore the 100% concentration was selected as highest concentration for the main study.
MAIN STUDY
SKIN REACTIONS / IRRITATION:
The very slight erythema of the ears as shown by all test item treated animals on at 1 to 6 Days during the observation period was considered not to have a toxicologically significant effect on the activity of the nodes.
CLINICAL OBSERVATIONS: No mortality occurred and no clinical signs of systemic toxicity were observed in the animals.
BODY WEIGHTS: Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
MACROSCOPIC EXAMINATION OF LyMPH NODES:
The majority of auricular lymph nodes were considered normal in size, except for the nodes in two animals treated at 100%, which were considered to be slightly enlarged.
No macroscopic abnormalities of the surrounding area were noted for the majority of animals. Pale discoloration of the surrounding area of the lymph nodes of the animals treated at 100% was noted, which was considered not to have affected the DPM values of these animals.
DETAILS ON STIMULATION INDEX CALCULATION : DPM (Disintegrations Per Minute) values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group using the individual SI values. The individual SI is the ratio of the DPM/animal compared to the DPM/vehicle control group mean.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not skin sensitising
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- In conclusion, since there is no indication that the test item elicited a SI ≥ 3 when tested up to 100%, SHR 1396 was considered not to be a skin sensitizer.
- Executive summary:
A LLNA study was performed following OECD guidelines and GLP principles. Three experimental groups of five females were treated with test item concentrations of 15%, 50% and 100%. One control group of five females was treated with the vehicle (Acetone/olive oil 1:4 v/v). All animals were treated for 3 consecutive days. Three days after the last exposure all animals were injected with 3H-methyl thymidine for measuring radioactivity. The activity was expressed as the number of disintegrations per minute (DPM) and a stimulation index (SI) was calculated for each group. The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at Charles River Den Bosch is an appropriate model for testing for contact hypersensitivity. No macroscopic abnormalities of the surrounding area were noted for the majority of animals. Pale discoloration of the surrounding area of the lymph nodes of the animals treated at 100% was noted, which was considered not to have affected the DPM values of these animals. Mean DPM/animal values for the experimental groups treated with test item concentrations 25, 50 and 100% were 717, 938 and 972 DPM, respectively. The mean DPM/animal value for the vehicle control group was 384 DPM. The SI values calculated for the test item concentrations 25, 50 and 100% were 1.9, 2.4 and 2.5, respectively. Since there was no indication that the test item elicited a SI ≥ 3 when tested up to 100%, SHR 1396 was considered not to be a skin sensitizer. Based on these results, SHR 1396 would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. The test item does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.