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EC number: 271-865-1 | CAS number: 68610-44-6
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
- Experimental in vivo study (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, OECD 422) on the analogue substance "Sodium coco β-iminodipropionate", CAS 3655 -00 -3
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 day (males)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- 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'
- Justification for type of information:
- Peer-reviewed US Government publication
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Remarks:
- Claimed GLP but no detail
- Limit test:
- no
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Details on mating procedure:
- Cohabitation
- 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
- 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
- Positive control:
- None
- 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
- Postmortem examinations (offspring):
- Yes, macroscopic examinations for malformation
- 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
- 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
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 43 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Reduced weight gain, adaptive changes to liver and kidneys
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 160 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Reduced weight gain, adaptive changes to liver and kidneys
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 600 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- 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
- Key result
- Reproductive effects observed:
- no
- 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 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. - 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.
The similarity in findings with work on primary amines further justifies read-across to these potential metabolites. This is reviewed in the assessment report attached in Section 13.
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- ANALOGUE APPROACH JUSTIFICATION:
See the read-across document - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 43 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 160 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 600 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- ca. 600 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Key result
- Reproductive effects observed:
- no
Referenceopen allclose all
Tubular degeneration/regeneration and hyaline droplets/granulation of the kidneys in males
Follicular hypertrophy of the thyroid in males and females
Acanthosis of the non-glandular stomach in males and females
Inflammation of the non-glandular stomach in males; and congestion, thrombosis and inflammation of the glandular stomach in females
No abnormalities reported
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.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
No effect on fertility were seen in an experimental screening in vivo study (OECD 422) on the analogue substance "Sodium coco β-iminodipropionate", CAS 3655 -00 -3.
By analogy, the test item "2 -Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide (water and methanol free) is expected not to have effect on fertility.
Additional information
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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