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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
Endpoint summary
Administrative data
Description of key information
Oral (OECD 420), rat: LD50 > 2000 mg/kg bw
Inhalation: Data waiving as studies for two other routes, i.e. oral and dermal, are provided.
Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Sep - 07 Oct 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 4166310
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature - Species:
- rat
- Strain:
- other: Wistar rats (Shoe:WIST)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DIMED Schönwalde GmbH, Schönwalde, Germany
- Weight at study initiation: 136 - 141 g
- Housing: the rats were kept in transparent polycarbonate cages (Macrolone type III) with two or three in each cage. Bedding was pinewood sawdust “Lignocel-Fasern”.
- Diet: pelleted complete rodent diet Altromin 1314, (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 Sep 2004 To: 07 Oct 2004 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 female (sighting study), 4 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 30 min, 2, 4 and 6 h after the administration 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 - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: All animals showed a hunched posture and piloerection 30 min, 2 and 4 h after the application of the test item. After 6 h piloerection was still observed. From Day 1 to the end of the observation period on Day 14 the animals were free of any abnormalities
- Gross pathology:
- Necropsy and histopathological examination revealted no substance-related findings.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1) performed with the registered substance, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006 (REACH).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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
- 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
- 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 - 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 - 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.
- 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.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises adequate and reliable (Klimisch score 1) studies performed with the registered substance and with analogue substances showing similar structure and intrinsic properties as for the registered substance. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in physico-chemical, ecotoxicological and toxicological properties. Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006 (REACH). Therefore, the available information fulfils the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 (REACH).
Additional information
Acute toxicity: oral
An acute oral toxicity study performed according to OECD TG 420 and in compliance with GLP with Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) is available (Frey-Tox, 2004a). In this limit test five fasted female Wistar rats (Shoe: WIST) were administered a single dose of 2000 mg/kg bw of the test substance via oral gavage. The animals were observed for 14 days after administration. No mortality occurred during the study period and body weight gain was normal. All animals showed a hunched posture and piloerection 30 minutes to six hours post administration. From day 1 to the end of the observation period, no further clinical signs of systemic toxicity were observed. Thus, the acute oral LD50 value was considered to be greater than 2000 mg/kg bw. Based on the study results and according to EU classification criteria, the test substance is not to be classified.
Acute toxicity: inhalation
No data on acute inhalation toxicity is required as data on two other routes of exposure, i.e. oral and dermal, are provided.
Acute toxicity: dermal
With respect to the registered substance, an acute dermal toxicity study was performed with Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) according to OECD TG 402 and in compliance with GLP (Frey-Tox, 2016). In this limit test five Wistar rats of each sex were exposed to a single dose of 2000 mg/kg bw of the neat test substance for 24 h via semi-occlusive dressing and observed for 14 days post-application. No mortalities occurred and no systemic clinical signs of toxicity related to the administration of the test item were observed up to the end of the 14-day observation period. Furthermore, no effect on body weight development was recorded during the study period. Macroscopic examination at the end of the study revealed no treatment-related changes. On day 1, very slight erythema formation (grade 1) was observed in 2/10 animals, whereas slight to well defined erythema (grade 2) were observed in 7/10 animals. Additionally, very slight edema formation (grade 1) was observed in 2/10 animals. On day 2, very slight erythema (grade 1) were observed in 5/10 animals and slight to well defined erythema (grade 2) were 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. Thus, the acute dermal LD50 value was considered to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
The available data on the registered substance Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) for both acute oral and acute dermal toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Data are therefore conclusive but not sufficient for classification. No data are, however, available regarding acute inhalation toxicity.
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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