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EC number: 700-185-4 | CAS number: 1122460-01-8
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-01-29 to 2009-02-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- , 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- , adopted 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl (ethylcarbamoyl)formate
- EC Number:
- 700-185-4
- Cas Number:
- 1122460-01-8
- Molecular formula:
- C14H25NO3
- IUPAC Name:
- (1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl (ethylcarbamoyl)formate
- Test material form:
- liquid: viscous
- Details on test material:
- - EC name: Acetic-acid, 2- (ethylamino) -2-oxo, (1R,2S,5R) -5-methyl- 2- (1-methylethyl)- cyclohexyl ester
- Molecular formula: C14H25NO3
- Molecular weight: 255.36g/mol
- Physical state: liquid, colourless, viscous oil
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- SPF Wistar rats of the stock Crl:WI
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany
- Weight at study initiation: 200 - 228 g; pilot study: 216 g
- Fasting period before study: the rats were not fasted prior dosing.
- Housing: the rats were kept in transparent macrolone cages (type 3-180, floor area 810 sq.cm) with two or three in each cage, males and females separated. The cages were cleaned and the bedding changed at least twice a week. Bedding was "Lignocel-Fasern" from Altromin, 32791 Lage, Germany.
- Diet (ad libitum): complete rodent diet "Altromin 1314" from Altromin, 32791 Lage, Germany.
- Water (ad libitum): domestic quality drinking water wtih hydrochloric acid to pH 2.5.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 %
- Air changes: 10 times / hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: On the day before the application of the test item the hair was removed from the back and flanks with an electric clipper. On day = the tet item was applied to the prepared skin area of 6x8 cm.
- Type of wrap if used: 4-layer gauze pack, the gauze packs were fixed with Microtape wound around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: mild soap and luke warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw. (sighting study / main study) - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw. (sighting study / main study)
- No. of animals per sex per dose:
- sighting study: one female (2000 mg/kg bw.)
main study: five female / five males (2000 mg/kg bw.) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each rat was observed 1, 3 and 6 hours after the start of dosing and thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0, 7 and 6 hours after the start of dosing and thereafter daily for a period of 14 consecutive days.
- Necropsy of survivors performed: yes; alle rats were killed by inhalation of CO2 on day 14 and subjected to a gross necropsy examination - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: PILOT STUDY The animal included in the pilot study appeared apathetic on day 0 after 1 hour, 3 hours and 6 hours. From day 1 to the end of the observation period on day 14 no abnormalities were revealed. MAIN STUDY The animals included in the main study
- Gross pathology:
- PILOT STUDY
The post mortem inspection revealed no pathological abnormalities.
MAIN STUDY
The post mortem inspection revealed no pathological abnormalities. - Other findings:
- Dermal reactions: there were no signs of dermal irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the SPF Wistar rats of the stock Crl:Wl was found to be greater than 2000 mg/kg bodyweight.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the dermal route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the dermal route.
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