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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-performed and well-documented study; recently performed Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- 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
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- Mating was performed using a ratio of 1:2 (male to females).At the mornings, the vaginal smear of the female was checked. The day on which sperms were observed in the vaginal smear was considered as gestation day '0'. After getting 100 sperm positive females, the remaining females and males were discarded.
- Duration of treatment / exposure:
- Gestatation day 5-19
- Frequency of treatment:
- Once per day
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
There were no mortalities in any of the treated and control groups during the study.
There were no significant clinical signs indicative of significant systemic toxicity. There were moving the bedding and slight to severe salivation in 300 and 1000 mg/kg groups. These were assumed to be due to the local effect of test item treatment. There were also isolated incidences of alopecia, crust, half eye closure, abnormal breathing in treated groups. These were considered to be incidental.
There were no effects on body weight and body weight gain. There were no effects on terminal body weight and adjusted maternal body weight in test item treated groups compared to the corresponding control groups.
There was statistically significantly lower food consumption between GD 5-8 in the 1000 mg/kg group compared to control. Considering no effect on body weight and body weight gain, the minor effect on food consumption was not considered to be adverse.
There were no adverse effects on hematology and clinical biochemistry parameters. There were no statistically significant differences between the control and test item treated group females except for the statistically significantly lower mean ASAT value in 1000 mg/kg group compared to control. This finding was considered to have no toxicological relevance.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no effects of test item treatment on the parameters of prenatal data. There were no differences in mean gravid uterus weight, number of live foetuses, number of resorptions (early, late and total), number of foetuses (male, female and total foetuses), sex ratio and percent post implantation losses between the control and test item treated group. There were no dead foetuses in the control and test item treated groups.
There were no effects of test item treatment on litter data including mean foetus weight, total litter weight, male litter weight and female litter weight. There were no statistically significant differences between the control and the test item treated groups.
There were no external, craniofacial and skeletal abnormalities considered to be of toxicological relevance noted in any of the treated groups. The statistical analysis showed no significant changes.
The internal examinations of the foetal viscera by the free-hand-microdissection showed dose responsive increase in the incidence of “dilated ureter (bilateral)” in treated groups compared to control attaining statistical significance at HD group. However, this finding is normally seen greater in fetuses than in pups and is considered part of normal aspects of renal development supporting the idea that these changes are transient and considered as variations [1], [2]. Therefore, the finding was not considered to be an adverse effect.
The references used are,
1. Solecki R et al., (2003) Harmonization of rat fetal external and visceral terminology and classification. Report of the Fourth Workshop on the Terminology in Developmental Toxicology, Berlin, 18–20 April 2002. Reprod Toxicol 17: 625-637
2. Teratology. 1972 Oct;6(2):191-6. "Apparent hydronephrosis" as a normal aspect of renal development in late gestation of rats: the effect of methyl salicylate. Woo DC, Hoar RM.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Table: Findings of foetal viscera |
|||||
|
Historical [%] |
Study 151945 [%] |
|||
Control |
100 mg/kg bw |
300 mg/kg bw |
1000 mg/kg bw |
||
Ureter B |
0.25 ± 0.65, max 2.46 |
0.83 |
3.67 |
6.06 |
8.85 |
Ureter L |
1.00 ± 1.18, max 4.44 |
8.33 |
4.59 |
9.09 |
8.85 |
Ureter R |
0.46 ± 0.90, max 3.33 |
1.67 |
0.92 |
5.05 |
0.88 |
S Dilated ureter either one sided or both sided |
1.71 |
10.83 |
9.18 |
20.2 |
18.59 |
Applicant's summary and conclusion
- Conclusions:
- The reproduction toxicity of the registration substance was investigated according to the Guideline OECD 414. Pregnant rats were treated at dose up to 1000 mg/kg bw. No significant maternal and developmental toxicity was found. The NOAEL of 1000 mg/kg bw was obtained.
- Executive summary:
The reproduction toxicity of the registration substance was investigated according to the Guideline OECD 414. Pregnant rats were treated at dose up to 1000 mg/kg bw. No significant maternal and developmental toxicity was found. The NOAEL of 1000 mg/kg bw was obtained.
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