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EC number: 939-579-8 | 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 March - 19 April 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study conducted in compliance with OECD guideline 420 with a minor deviation that does not affect study reliability: no rationale was reported for testing additional animals at 2000 mg/kg bw, despite the mortality noted with the first animal in the sighting test.
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:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- no rationale was provided to test other animals at 2000 mg/kg bw, despite the death of the animal tested in the sighting test at this dose.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- yes
- Remarks:
- no rationale was provided to test other animals at 2000 mg/kg bw, despite the death of the animal tested in the sighting test at this dose.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of sodium 3-{[3-(diethylamino)propyl]carbamoyl}-2-(dodecylamino)propanoate and sodium 3-{[3-(diethylamino)propyl]carbamoyl}-3-(dodecylamino)propanoate
- EC Number:
- 939-579-8
- Molecular formula:
- Empirical Formula : C11H21N3O3Na C2nH4n+1 (n=4 – 9), C11H21N3O3NaC18H35, C11H21N3O3NaC18H33 Molecular formula of the two main constituents : C23H46N3O3Na
- IUPAC Name:
- Reaction mass of sodium 3-{[3-(diethylamino)propyl]carbamoyl}-2-(dodecylamino)propanoate and sodium 3-{[3-(diethylamino)propyl]carbamoyl}-3-(dodecylamino)propanoate
- Details on test material:
- - Name of test material (as cited in study report): CHIMEXANE HB
- Physical state: Yellowish thick gel
- Analytical purity: 55.9 %
- Lot/batch No.: 0126344
- Date of receipt: 21 February 2006
- Expiration date of the lot/batch: March 2007
- Storage condition of test material: At room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 198 ± 8 g
- Fasting period before study: Animals were fasted for an overnight period of approximately 18 h before dosing, but had free access to water. Food was given back approximately 4 h after administration of the test item.
- Housing: Animals were housed in polycarbonate cages with stainless steel lid. Each cage contained 1-7 rats/sex during the acclimation period and 1 rat (sighting test) and 3 or 5 rats/sex/group (main test) during the treatment period.
- Diet (e.g. ad libitum): SsniffR/M-H pelleted diet (SSNIFF Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 µ), ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - Amount of vehicle (if gavage): 10 mL/kg bw
- Rationale for the selection of the starting dose: A preliminary test (sighting test) preceded the main test in which the test item was administered at the dose level of 2000 mg/kg bw to one female. Despite the mortality noted with this first animal, a second female was treated at the concentration of 2000 mg/kg bw. As no mortality occurred, the test item was administered at 2000 mg/kg bw in the main test to three additional females. - Doses:
- - Sighting test: 2000 mg/kg bw
- Main test: 300 and 2000 mg/kg bw - No. of animals per sex per dose:
- - Sighting test: 2 females
- Main test: 3 or 5 females - Control animals:
- other: historical control data
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: Animals were observed frequently during the hours following administration of the test item; subsequently once daily up to 14 days
Body weight was recorded on Days 1 (just before administration), 8 and 15.
- Necropsy of survivors performed: Yes, all surviving animals were killed by carbon dioxide asphyxiation on Day 15.
- All animals were subjected to a macroscopic examination which consisted of opening the thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded. - Statistics:
- None
Results and discussion
- Preliminary study:
- In the sighting test, the test item was first administered at the dose level of 2000 mg/kg bw to one female. Despite the mortality noted with this first animal, a second female was treated at the concentration of 2000 mg/kg bw. As no mortality occurred, the test item was administered at the dose-level of 2000 mg/kg bw in the main test to three additional females.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - At 2000 mg/kg bw: 2/5 females were found dead on Day 2 or 3.
- At 300 mg/kg bw: No mortality was noted. - Clinical signs:
- other: - At 2000 mg/kg bw: Hypoactivity, piloerection and dyspnea were noted in 2/5 females prior to the death, from Day 1. Soft faeces were also noted in one female on Day 1 only. Piloerection, concurrently with hypoactivity and/or dyspnea were observed in surv
- Gross pathology:
- - No macroscopic abnormalities were observed at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 for CHIMEXANE HB is greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats therefore it is classified as ‘R22 Harmful if swallowed’ according to the Annex VI to the Directive 67/548/EEC and ‘Category 4’ according to the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a GLP acute oral toxicity study performed according to OECD Guideline 420, groups of female Sprague Dawley [Rj: SD (IOPS Han)] rats were given a single oral dose of CHIMEXANE HB at 300 and 2000 mg/kg bw. A preliminary test (sighting test) preceded the main test in which the test item was administered at the dose level of 2000 mg/kg bw to one female. Despite the mortality noted with this first animal, a second female was treated at the concentration of 2000 mg/kg bw. As no mortality occurred, the test item was administered at 2000 mg/kg bw in the main test to three additional females. All animals were observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
At 2000 mg/kg bw, 2/5 females were found dead on Day 2 or 3. Hypoactivity, piloerection and dyspnea were noted prior to the death, from Day 1. Soft faeces were also noted in one of them on Day 1 only. Piloerection, concurrently with hypoactivity and/or dyspnea were observed in surviving animals between Days 1 and 3. At 300 mg/kg bw, no mortality and no clinical signs were observed. When compared to historical control animals, a slightly reduced body weight gain was noted in 1/5 and 2/5 females at 300 and 2000 mg/kg bw, respectively. The overall body weight gain of the other treated animals was not affected by treatment with the test item. No macroscopic abnormalities were observed at study termination on Day 15. In this study, the oral LD50 of CHIMEXANE HB was considered to be 300-2000 mg/kg bw in female rats.
The oral LD50 for CHIMEXANE HB is greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats therefore it is classified as ‘R22 Harmful if swallowed’ according to the Annex VI to the Directive 67/548/EEC and ‘Category 4’ according to the CLP Regulation (EC) N° (1272-2008).
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