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Diss Factsheets
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EC number: 486-070-7 | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 12 Sep 2007 to 29 Nov 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to an international test guideline and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Wölferstrasse 4, 4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks for males and 11 weeks for females
- Weight at study initiation: approximately 250 g for males and 200 for females
- Fasting period before study: No
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation.
- Diet (e.g. ad libitum):Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum. Results of analyses for contaminants will be archived at RCC Ltd.
- Water (e.g. ad libitum):Community tap-water, from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses will be archived at RCC Ltd.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (music during the daytime light period)
IN-LIFE DATES: From 20 sep 2007 to 04 Oct 2007
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of the animals
- % coverage: 10% of the total body surface
- Type of wrap if used: The semi-occlusive dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.90 mL/kg bw
- Concentration (if solution): 1.0553 g/mL
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Daily during the acclimatization period, at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
- Frequency of weighing:On test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded. Local signs: Once daily during days 2-15. All abnormalities were recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured during the study.
- Clinical signs:
- other: No clinical signs were observed during the observation period.
- Gross pathology:
- Effects on organs: No macroscopic findings were recorded at the scheduled necropsy.
- Other findings:
- Signs of toxicity (local):
At removal of the patch, no local signs were observed in any animal. However, on test day 5, one female exhibited a slight local erythema. Additionally, slight scaling was recorded at the same observation time point up to day 8 (in the same female). Otherwise, no local reactions were observed in any other animal up to the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not harmul by the dermal route.
- Executive summary:
In an acute dermal toxicity study ((RCC 2007 study n° B31195), 5 male and 5 female Wistar rats were dermally exposed to undiluted Dimethyl 2-methyl glutarate for 24 hours to 10% of body surface area at the dose of 2000 mg/kg bw. Animals were then observed for 14 days.
Dermal Combined LD50> 2000 mg/kg bw.
Dimethyl 2-methyl glutarate is not classified based on the LD50.
No mortality and no clinical signs were noted during the study. No local signs were observed in any animal except for one female which exhibited a slight local erythema on day 5 and a slight scaling from days 5 to 8. There was no effect on body weight gain.
This acute dermal study is classified as acceptable. It does satisfy the guideline requirement for an acute dermal study (OECD402) in the rat.
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.
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