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EC number: 268-130-2 | CAS number: 68003-46-3
- 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:
- 17 Feb - 29 Mar 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ammonium N-methyl-N-(1-oxododecyl)glycinate
- EC Number:
- 268-130-2
- EC Name:
- Ammonium N-methyl-N-(1-oxododecyl)glycinate
- Cas Number:
- 68003-46-3
- Molecular formula:
- C15H29NO3.H3N
- IUPAC Name:
- ammonium 2-(N-methyldodecanamido)acetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Weight at study initiation: 220 - 282 g
- Housing: The rats were caged in macrolone cages (type 3) individually during the 24 h application and separately according to sex in groups of 2 or 3 during the remaining time. The animals were provided with specific environment material such as hay bricks (Provimi Kliba AG, Kaiseraugust, Switzerland) as well as hiding tunnels of polycarbonate (Plexx, Netherlands). Lignocel-Granulat (Altromin, Lage, Lippe, Germany) served as bedding material.
- Diet: pelleted diet Altromin 1324 (Altromin, Lage, Lippe, Germany), ad libitum
- Water: tap water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- 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: back/flanks (6 x 8 cm)
- Type of wrap if used: The test material was applied onto the shaved skin and covered with 4-layered gauze which was fixed with adhesive tape (Gothaplast) by wrapping the trunk of the animals.
REMOVAL OF TEST SUBSTANCE
- Washing: The bandage and gauze were removed after the exposure time and residual test material was removed using mild soap and lukewarm water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 1 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw (range finding study)
2000 mg/kg bw (main study) - No. of animals per sex per dose:
- 1 female (range finding study)
5 males and 5 females (main study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed for mortality and clinical signs 1, 3 and 6 h after test material application and thereafter daily for a period of 14 consecutive days. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- The animal showed piloerection one and three hours after test material application of a dose of 2000 mg/kg bw. Six hours after test material application as well as from day 1 to the end of the observation period on day 14, the animal was free of any abnormalities. After termination of the 24 h application on day 1, a slight to well defined erythema (grade 2) was displayed on the treated skin areas, but no edema was observed. On day 2, a very slight erythema (grade 1) was still observed, whereas no skin reactions were recorded on day 3 until the remaining study period.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: very slight to slight erythema and very slight edema were observed up to day 3 after test material application but fully reversible within 4 days
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Both, all female and male animals did not show any abnormalities after the dermal application of a dose of 2000 mg/kg bw during the entire 14-day observation period.
- Gross pathology:
- All animals did not display any pathological alterations during macroscopically examination.
- Other findings:
- On day one, a very slight erythema (grade 1) was observed in 2/10 animals, whereas a slight to well defined erythema (grade 2) was observed in 7/10 animals. Additionally, a very slight edema (grade 1) was observed in 2/10 animals. On day 2, very slight erythema (grade 1) were observed in 5/10 animals and a slight to well defined erythema (grade 2) was recorded in 4/10 animals. Very slight erythema (grade 1) were also observed in 3/10 animals on day 3 after test material application. Furthermore, the treated skin areas of 6/10 animals displayed isolated scales (day 3). However, all skin reactions were fully reversible within 4 days after application of the test material until the end of the study period.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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