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EC number: 816-311-7 | CAS number: 76589-16-7
- 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:
- 30 Jan 2017 - 21 Feb 2017
- 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:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-methoxy-2-methylheptane
- EC Number:
- 816-311-7
- Cas Number:
- 76589-16-7
- Molecular formula:
- C9H20O
- IUPAC Name:
- 2-methoxy-2-methylheptane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Identification DAIKON ETHER
Appearance Colourless liquid
Chemical name (IUPAC), synonym or trade name 2-Methoxy-2-methylheptane
CAS Number 76589-16-7
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Species: Mouse
Strain: CBA/J
Condition: Inbred, SPF-Quality
Number of Animals: 25 Females (nulliparous and non-pregnant). Five females per group.
Age at the Initiation of Dosing: Young adult animals (approximately 10 weeks old) were selected.
Weight at the Initiation of Dosing: 18.8 to 23.1 g.
Housing: polycarbonate cages containing sterilized sawdust as bedding material
Mean temperature: 22°C
Mean relative humidity: 42 to 47%
Photoperiod: 12-hour light/12-hour dark cycle
Air change: Ten or greater air changes per hour with 100% fresh air (no air recirculation)
Food: Pelleted rodent diet, ad libitum
Water: Municipal tap-water was freely available
Animal Enrichment: animals were provided with paper
Study design: in vivo (LLNA)
- Vehicle:
- other: Ethanol/diethylphthalate (1:3 v/v)
- Concentration:
- 0, 25, 50, 100 % w/w
- No. of animals per dose:
- 5
- Details on study design:
- Pre-screen Test: Two test item concentrations were tested; a 50% and 100% concentration. The highest concentration was the maximum concentration as required in the test guidelines.
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 and another group of five animals was treated with the positive control item.
Induction - Days 1, 2 and 3
Excision of the Nodes - Day 6
Tissue Processing for Radioactivity - Day 6
Radioactivity Measurements - Day 7 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The SI value calculated for the positive control group was 3.3.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.5
- Test group / Remarks:
- concentration: 25% of test item
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- concentration: 50% of test item
- Key result
- Parameter:
- SI
- Value:
- 4.3
- Test group / Remarks:
- concentration: 100% of test item
Any other information on results incl. tables
Skin Reactions / Irritation
No irritation was observed in any of the test item treated or vehicle control animals, very slight erythema was noted for all positive control item treated animals between Days 1 and 3., which was considered not to have a toxicologically significant effect on the activity of the nodes.
White test item remnants were present on the dorsal surface of the ears of all animals at 100% (between Days 1 and 6), which did not hamper scoring of the skin reactions.
Systemic Toxicity
No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
8.2.3. Macroscopic Examination of the Lymph Nodes and Surrounding Area
The majority of auricular lymph nodes were considered normal in size, except for one node in one animal treated with the positive control, which was considered enlarged. No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Radioactivity Measurements and SI Values
Mean DPM/animal values for the experimental groups treated with test item concentrations 25, 50 and 100% were 1132, 1518 and 3322 DPM, respectively. The mean DPM/animal value for the vehicle control group was 769 DPM and a mean DPM/animal value of 2522 DPM was obtained from the positive control group. The SI values calculated for the test item concentrations 25, 50 and 100% were 1.5, 2.0 and 4.3, respectively. The SI value calculated for the positive control group was 3.3.
See attachment
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on these results:
• according to the recommendations made in the test guidelines (including all amendments), the test substance would be regarded as skin sensitizer.
• according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), the test item should be classified as skin sensitizer (Category 1B).
• according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), the test item should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction.
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