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EC number: 258-081-5 | CAS number: 52663-87-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see remark
- Remarks:
- Work performed to OECD guidelines in 2009 and approved by the US Environmental Protection Agency Statement in report claiming the data covers range of alklyimines; specifically, "sodium and potassium salts of N-alkyl (C8-C18)-beta-iminodipropionic acid where the C8-C18 is linear and may be saturated and/or unsaturated, (CAS Reg. Nos. 110676-19-2, 3655-00-3, 61791-56-8, 14960-06-6, 26256-79-1, 90170-43-7, 91696-17-2, and 97862-48-1) [Ref 40 CFR Part 180, Federal Register Volume 76, number 24, 4 February 2011'
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developme ntal Toxicity Screening Test)
- GLP compliance:
- not specified
- Remarks:
- Claimed GLP but no detail
- Limit test:
- no
Test material
- Reference substance name:
- Disodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- EC Number:
- 222-899-0
- EC Name:
- Disodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- Cas Number:
- 3655-00-3
- IUPAC Name:
- disodium N-(2-carboxyethyl)-N-dodecyl-beta-alaninate
- Reference substance name:
- sodium and potassium salts of N-alkyl (C8-C18)-beta-iminodipropionic acid
- IUPAC Name:
- sodium and potassium salts of N-alkyl (C8-C18)-beta-iminodipropionic acid
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- Batch number 184, state 87% purity
Dose levels were corrected for purity (ie reported figures are for nominal 100% purity)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: other: HanRcc:WIST (SPF)
Administration / exposure
- Route of administration:
- oral: gavage
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Dosing began 14 days before mating and continued for 28 days for males and for day four of lactation for females
- Frequency of treatment:
- Daily
- Duration of test:
- 28 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 600 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 160 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 43 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10 males and 10 females per group
- Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- Parental animals: Observations and examinations
Clinical signs daily (including maternal behaviour)
Functional observation battery (FOB)
Food consumption
Body weights
Blood sampling
Body temperature (during FOB)
Litter observations
Litter size and viabilty
Postmortem examinations (parental animals)
Yes - Fetal examinations:
- Yes, macroscopic examinations for malformation
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Taste aversion behaviour
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Yes, intermediate and high dose
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Yes, intermediate and high dose
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in liver in higher dose animals
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver and kidney
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver and kidney
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance intake: Decrease in top groups pre-mating
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- male/female
- Effect level:
- > 43 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Basis for effect level:
- other: Reduced weight gain, adaptive changes to liver and kidneys
- Dose descriptor:
- NOAEL
- Remarks:
- male/female
- Effect level:
- ca. 160 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Basis for effect level:
- other: Reduced weight gain, adaptive changes to liver and kidneys
- Dose descriptor:
- LOAEL
- Remarks:
- male/female
- Effect level:
- ca. 600 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Basis for effect level:
- other: see remark
Maternal abnormalities
- Abnormalities:
- no effects observed
- Description (incidence and severity):
- Reported effects were considered to be caused by systemic toxicity and did not affect reproductive performance
Results (fetuses)
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- External malformations:
- not specified
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- No clinical signs observed
- Details on embryotoxic / teratogenic effects:
- No adverse effects on litter size or viability. No abnormalities reported.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 600 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects on litter size or viability. No malformations reported.
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
No treatment-related effects on litter size or survival were observed. No treatment-related effects on body weight were observed in offspring. Body weight gain was slightly decreased in males and females at 160 and 600 mg/kg/day, but there was no dose response.
No findings were observed on macroscopic examination of the offspring. The reproductive/ developmental LOAEL for Sodium coco β-iminodipropionate in rats is not established.
The reproductive/developmental NOAEL is 600 mg/kg bw/day, the highest dose tested, in males and females.
Applicant's summary and conclusion
- Conclusions:
- No treatment-related effects on litter size or survival were observed. No treatment-related effects on body weight were observed in offspring. Body weight gain was slightly decreased in males and fem ales at 160 and 600 mg/kg/day, but there was no dose response.
No findings were observed on macroscopic examination of the offspring. The reproductive/developmental LOAEL for Sodium coco β-iminodipropionate in rats is not established.
The reproductive/developmental NOAEL is 600 mg/kg bw/day, the highest dose tested, in males and females. - Executive summary:
This EPA study is considered valid in terms of grouping of substances. Examination of data on various primary alkylamines show little difference in repeat toxicity effects, including reproduction, suggesting that there is minimal difference in terms of systemic toxicity between the different alklyamines, including
branched and linear.
The comparison of sub-acute toxicity between the tested substance and the result of this EPA study are consistent and read-across is considered valid; the EPA study shows slightly more adverse effects than the Key Study (on the registered substance) over 28 days and is therefore considered a suitable surrogate for the reporting of reproductive effects.
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