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EC number: 800-765-8 | CAS number: 1424149-03-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; well-performed and well-documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate
- EC Number:
- 800-765-8
- Cas Number:
- 1424149-03-0
- Molecular formula:
- C21H40NO4.1/2Na.1/2C6H15NO3
- IUPAC Name:
- sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once per day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 250, 750 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Details on results:
- No Test Item related mortality occurred in this study.
Clinical symptoms observed during treatment and recovery period are related to local irritation of the Test Item. Dose-dependently moving of the bedding, salivation and piloerection were noted in the 250 and 750 mg/kg bw groups. No Test Item related findings were noted during weekly detailed clinical observation and in parameters of the functional observation battery. There were no biologically relevant differences in body temperature between the groups.
No Test Item related effect on body weight development and food consumption was observed during the treatment or recovery period of this study.
No Test Item related effect on haematological parameters and coagulation parameters were noted at the end of the treatment or recovery period.
No Test Item related effect on parameters of clinical biochemistry was noted at the end of the treatment or recovery period. A slightly lower serum level of Total Bile Acids in the 250 and 750 mg/kg bw groups at the end of the treatment period is not considered an adverse effect.
No Test Item related effect on urinary parameters was noted at the end of the treatment or recovery period.
There were no adverse Test Item related macroscopic findings in this study.
A higher liver weight in the 750 mg/kg bw group found at the end of the treatment period and associated with minimal centrilobular hepatocellular hypertrophy is considered an adaptive response to the Test Item and is not assumed to be adverse.
The premature death of one male rat treated at 250 mg/kg/day was considered to be due to gavage accident. All other animals survived until scheduled necropsy.
At terminal sacrifice, test item-related histopathological findings considered to be toxicologically relevant were seen in the liver and thyroid gland, in a low proportion of animals and at 750 mg/kg/day only. In the liver, minimal centrilobular hepatocellular hypertrophy was noted, corroborating the higher mean liver weight recorded in this group. In the thyroid gland, a minimal diffuse follicular cell hypertrophy was observed and considered to be secondary to the liver change. The liver and thyroid gland findings recovered completely during the recovery period.
Furthermore, in the nonglandular part of the stomach (at 750 mg/kg/day) and in the trachea (in all test item-treated groups, without clear dose-relationship), epithelial changes were seen which were considered to be indicative of a local irritant effect of the test item formulation, and therefore to be toxicologically irrelevant. They were no longer seen after the recovery period.
As a conclusion, histopathological liver and associated thyroid gland changes were minor in degree, restricted to the 750 mg/kg/day dose group and resolved during the recovery period. No other toxicologically relevant lesions were noted in pathology. Therefore, the dose of 750 mg/kg/day is considered to be the NOAEL (No Observed Adverse Effect Level) for pathology under the conditions of this study.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 750 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Up to the highest applied dose of 750 mg/kg bw no signs of systemic toxicity were found.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table: Effects found in the provided study presented only if deviating values were obtained for controls and treated animals |
|||||||
At the time administration was concluded |
At the time recovery was concluded |
||||||
Vehicle control (n = 5) |
100 mg/kg bw (n = 5) |
250 mg/kg bw (n = 4) |
750 mg/kg bw (n = 5) |
Vehicle control (n = 5) |
750 mg/kg bw (n = 5) |
||
Clinical Chemistry |
|||||||
ALAT [U/L] |
Males |
19.28 ± 2.27 |
16.74 ± 0.84 |
17.63 ± 1.91 |
15.20** ± 1.03 |
16.50 ± 1.43 |
14.20* ± 1.19 |
females |
13.85 ± 1.93 |
12.65 ± 2.09 |
11.64 ± 1.76 |
13.13 ± 6.04 |
11.74 ± 1.12 |
16.34 ± 5.39 |
|
TBA [µmol/L] |
Males |
63.75 ± 48.64 |
61.34 ± 67.12 |
45.83 ± 15.14 |
21.20 ± 9.67 |
36.28 ± 15.08 |
47.94 ± 30.90 |
females |
33.87 ± 13.88 |
35.19 ± 30.76 |
15.43 ± 12.58 |
11.57 ± 7.72 |
26.72 ± 14.86 |
14.17 ± 10.05 |
|
Gluc [mmol/L] |
Males |
6.86 ± 1.98 |
9.81 ± 0.79 |
8.32 ± 1.77 |
11.65 ** ± 2.61 |
8.85 ± 2.24 |
8.82 ± 0.53 |
females |
5.19 ± 0.86 |
5.80 ± 0.64 |
5.73 ± 0.21 |
5.89 ± 0.34 |
6.91 ± 1.14 |
7.54 ± 2.46 |
|
Organ weight |
|||||||
Liver [g] |
Males |
8.04 ± 0.35 |
8.52 ± 0.47 |
8.54 ± 0.81 |
9.86** ± 0.78 |
8.56 ± 0.66 |
8.48 ± 0.86 |
females |
5.31 ± 0.18 |
5.62 ± 0.64 |
4.98 ± 0.37 |
6.50 ** ± 0.71 |
4.91 ± 0.13 |
5.42 ± 0.54 |
Mean ± SD
*: significantly different from vehicle control at p < 0.05
**: significantly different from vehicle control at p < 0.01
Applicant's summary and conclusion
- Conclusions:
- The registration substance was investigated for its repeated dose toxicity according to the OECD Guideline 407. The rats were given the registration substance per gavage at doses of 0, 100, 250 and 750 mg/kg bw. The study comprised also the recovery groups for vehicle control and 750 mg/kg bw.
The NOAEL of 750 mg/kg bw was found. - Executive summary:
The registration substance was investigated for its repeated dose toxicity according to the OECD Guideline 407. The rats were given the registration substance per gavage at doses of 0, 100, 250 and 750 mg/kg bw. The study comprised also the recovery groups for vehicle control and 750 mg/kg bw.
No signs of treatment related systemic toxicity were observed with reference to mortality, clinical symptoms, body weight development, food consumption, haematology, clinical biochemistry, urinalysis, macroscopical examination. Increased liver weight at a dose level of 750 mg/kg/day was considered as an adaptive and reversible response. Histopathologically, liver and associated thyroid gland changes were minor in degree, restricted to the 750 mg/kg/day dose group and resolved during the recovery period. No other toxicologically relevant lesions were noted in pathology. Therefore, the dose of 750 mg/kg/day is considered to be the NOAEL (No Observed Adverse Effect Level) for pathology under the conditions of this study.
Slight clinical symptoms and epithelial changes in the nonglandular part of the stomach and in the trachea at 750 mg/kg/day indicate a local irritant effect.
Overall, the dose level of 750 mg/kg/day is considered to be the NOAEL (No Observed Adverse Effect Level) for this study.
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