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EC number: 619-508-4 | CAS number: 381209-09-2
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 9, 2010 - February 17, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-(2-ethylbutyl)cyclohexane-1-carboxylic acid
- EC Number:
- 619-508-4
- Cas Number:
- 381209-09-2
- Molecular formula:
- C13 H24 O2
- IUPAC Name:
- 1-(2-ethylbutyl)cyclohexane-1-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): CAT-Acid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Density: 0.98 g/mL
- pH (1% in water, indicative range): 5.4-5.2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI (outbred, SPF-Quality)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 174-192 g
- Fasting period before study: overnight prior to dosing
- Housing: group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.)
- Diet (e.g. ad libitum): pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany); animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance.
- Water (e.g. ad libitum): tap water (ad libitum)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 – 21.4ºC
- Humidity (%): 43 - 71%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSE VOLUME APPLIED:
- 2.041 mL/kg (2000 mg/kg)
- 0.306 mL/kg (300 mg/kg) - Doses:
- - 2000 mg/kg (1 group)
- 300 mg/kg (2 groups) - No. of animals per sex per dose:
- - 3 females for the 2000 mg/kg dose (1 group)
- 6 females for the 300 mg/kg dose (2 groups) - Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: twice daily, the time of death was recorded as precisely as possible.
Bodyweights: Days 1 (pre-administration), 8 and 15 and at death (if found dead or sacrificed after Day 1)
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 2000 mg/kg, one female was found dead and one female was sacrificed in extremis, both on Day 2. The remaining animal at 2000 mg/kg and all animals treated at 300 mg/kg survived up to the scheduled study duration.
- Clinical signs:
- other: - At 2000 mg/kg: lethargy, hunched posture, uncoordinated movements, piloerection, salivation, ptosis, hypothermia and/or yellow genital region between Days 1 and 3 (all animals; for one animal, hunched posture was also noted on Days 6 and 7) - At 300 mg/
- Gross pathology:
- No abnormalities were found.
Any other information on results incl. tables
Dose level |
Number of animals and their sex |
Date of treatment |
Mortality data |
2000 mg/kg |
3 females |
November 9, 2010 |
2/3 |
300 mg/kg |
3 females |
November 11, 2010 |
0/3 |
300 mg/kg |
3 females |
November 12, 2010 |
0/3 |
- The LD50 value, based on OECD guideline 423 and LD50 cut-off values, is considered to be 1000 mg/kg (see Annex 2d of OECD 423)
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An acute oral toxicity study has been conducted according to OECD 423 and GLP in a total of 9 female rats. A group of 3 female rats were treated at a dose level of 2000 mg/kg. At this dose level, one female was found dead and one animal was sacrificed in extremis both on day 2. Therefore, 2 further groups of 3 female rats were dosed at 300 mg/kg. At this dose level, all animals survived up to the scheduled study duration. Clinical signs observed at the 2000 mg/kg dose level were: lethargy, hunched posture, uncoordinated movements, piloerection, salivation, ptosis, hypothermia and/or yellow genital region between Days 1 and 3 (all animals; for one animal, hunched posture was also noted on Days 6 and 7). At the 300 mg/kg dose level, the observed effects of treatment were hunched posture and piloerection between Days 1 and 4 (all animals). Autopsy revealed no abnormalities. Since at the second dose level of 300 mg/kg no mortality was observed, it is concluded that the LD50 is between 300 and 2000 mg/kg. Therefore based on the results of this study the substance needs to be classified as Acute Tox. Cat.4, Harmful if swallowed (H302) in accordance with the CLP Regulation.
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