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EC number: 202-878-2 | CAS number: 100-68-5
- 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:
- 11th May 2010 to 10th August 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Proprietary guideline study, compliant with GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- A deviation from maximum and minimum relative humidity occurred. However, this did not affect the validity of the study.
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Thioanisole
- IUPAC Name:
- Thioanisole
- Reference substance name:
- Methyl phenyl sulphide
- EC Number:
- 202-878-2
- EC Name:
- Methyl phenyl sulphide
- Cas Number:
- 100-68-5
- Molecular formula:
- C7H8S
- IUPAC Name:
- (methylsulfanyl)benzene
- Details on test material:
- - Name of test material (as cited in study report): Thioanisole
- Molecular formula (if other than submission substance): C7H8S
- Molecular weight (if other than submission substance): 124.19
- Smiles notation (if other than submission substance): Not documented
- InChl (if other than submission substance): Not documented
- Structural formula attached as image file (if other than submission substance): see Fig. Not documented
- Substance type: Not documented
- Physical state: Colourless to slightly yellowish liquid
- Analytical purity: 99% minimum
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: Not documented
- Isomers composition: Not documented
- Purity test date: Not documented
- Lot/batch No.: 100310
- Expiration date of the lot/batch: 23rd March 2011
- Radiochemical purity (if radiolabelling): Not documented
- Specific activity (if radiolabelling): Not documented
- Locations of the label (if radiolabelling): Not documented
- Expiration date of radiochemical substance (if radiolabelling): Not documented
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature protected from light under nitrogen.
- Other: Use amber coloured glassware or wrap container in tin foil when handling.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J strain
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: 19 - 23g
- Housing: Individually housed in labelled Macrolon cages (MI type; height 12,5cm) containing sterilized sawdust as bedding material. Paper was supplied as cage enrichment. The paper was removed on Day 1 prior to dosing and was supplied again after scoring of the ears on Day 3. During the acclimatization period, the animals were group housed in Macrolon cages (MI type; height 18cm).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: At least 5 days before the start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3°C (actual range: 19.7 - 22.9°C)
- Humidity (%): 40 - 70% (actual range: 38 - 81%)
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.
IN-LIFE DATES: From: 17 May 2010 To: 14 June 2010
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 10, 25 and 50%
- No. of animals per dose:
- Five females per group
- Details on study design:
- RANGE FINDING TESTS:
A preliminary irritation study was conducted in order to select the highest test substance concentration to be used in the main study. Initially two test substance concentrations were tested, 50% and 100% concentration. Two young adult animals were selected. Each animal was treated with one concentration on three consecutive days. Approximately 3-4 days after the last exposure, the irritation of the ears was assessed. Bodyweights were determined on Day 3. The animals were sacrificed after the final observation. No necropsy was performed. Based on the death of the animal at 100% on Day 2, two additional animals were treated in a similar manner with 2 lower concentrations, specifically 25% and 10% immediately after the animals were found dead.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Three groups of five animals were treated with one test substance concentration per group. The highest test substance concentration was selected from the preliminary irritation study. One group of five animals was treated with the vehicle.
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: If the results indicate a Stimulation Index equal to or greater than 3, the test substance should be considered to be a skin sensitiser.
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance formulations were prepared within 4 hours prior to each treatment. Test substance and formulations were protected from light using amber coloured glassware or aluminium foil. No adjustment was made for specific gravity of the vehicle. Homogeneity was obtained to visually acceptable levels.
Induction:
The dorsal surface of both ears was epidermally treated (25 µL/ear) with the test substance concentration at approximately the same time each day. The concentrations were mixed thoroughly using a vortex mixer immediately prior to dosing. This process occurred for three successive days. On the 6th day, excision of the nodes and processing the tissues for radioactivity occurred. Radioactivity measurements were made on day 7. - Positive control substance(s):
- other: Alpha-hexylcinnamicaldehyde
- Statistics:
- No information provided
Results and discussion
- Positive control results:
- A six monthly check for assay validity and method integrity was completed using the positive control material alpha- hexylcinnamicaldehyde. This confirmed the methods used and the lab conduct of the assay were acceptable to identify a known weak to moderate sensitiser .
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The Stimulation Index values calculated for the substance concentrations 10, 25 and 50% were 1, 2.3 and 4.9 respectively. A linear dose response and an SI of greaterthan 3.0 confirmed Thioanisole is a potential skin sensitiser
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The mean DPM/animals values for the experimental groups treated with the test substance concentrations of 10, 25 and 50% were 693, 1508 and 3275 DPM respectively. The mean DPM value for the control group was 662.
Any other information on results incl. tables
Preliminary Study:
Based on the results of this study, the highest test susbtance concentration selected for the main study was a 50% concentration.
Main Study:
Skin reactions:
Slight irritation of the ears was shown by all experimental animals at all three concentrations. However, this was not considered to have a toxicologically significant effect on the activity of the nodes. No oedema was observed in any of the animals examined.
Macroscopic examination:
All auricular lymph nodes of the animals at 50% concentration were considered increased in size. All other auricular lymph nodes were considered normal in size. No macroscopic abnormalities of the surrounding area were noted in any of the animals.
Body Weights:
Body weights and body weight gain of experimental animals remained in the same range as the controls over the study period. The slight body weight loss in some animals was not considered toxicologically significant.
Toxicity / Mortality:
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the test substance, Thioanisole, should be considered to be a skin sensitiser. Based on these results, the test substance should be classified as a Category 1 skin sensitizer and have the hazard statement H317: May casue an allergic reaction associated with it, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified with the risk phrase R43: May cause sensitization by skin contact and have the symbol Xi, Irritant associated with it.
- Executive summary:
In a study conducted by Beerens-Heijnen (2010), the test substance, Thioanisole, was examined for its ability to cause skin sensitization when applied to female CBA/J strain of mice in a Local Lymph Node Assay. The test substance was applied to the dorsal surface of the ear of each rabbit for three consecutive days at concentrations of 10, 25 and 50% (w/w). On day 6 of experimentation, the auricular lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were made and results expressed as the number of Disintegrations per Minute (DPM). A Stimulation Index (SI) was calulated for each group. The mean DPM/animals values for the experimental groups treated with the test substance concentrations of 10, 25 and 50% were 693, 1508 and 3275 DPM respectively. The mean DPM value for the control group was 662DPM. The Stimulation Index values calculated for the substance concentrations 10, 25 and 50% were 1, 2.3 and 4.9 respectively. Slight irritation of the ears was shown by all experimental animals at all three concentrations. However, this was not considered to have a toxicologically significant effect on the activity of the nodes. No oedema was observed in any of the animals examined. All auricular lymph nodes of the animals at 50% concentration were considered increased in size. All other auricular lymph nodes were considered normal in size. No macroscopic abnormalities of the surrounding area were noted in any of the animals. Body weights and body weight gain of experimental animals remained in the same range as the controls over the study period. The slight body weight loss in some animals was not considered toxicologically significant. No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study. Under the conditions of this study, the test substance, Thioanisole, should be considered to be a skin sensitiser. Based on these results, the test substance should be classified as a Category 1 skin sensitizer and have the hazard statement H317: May casue an allergic reaction associated with it, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified with the risk phrase R43: May cause sensitization by skin contact and have the symbol Xi, Irritant associated with it.
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