Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-066-5 | CAS number: 77-89-4
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity and glucose tolerance induction by acetyltriethylcitrate, substitute plasticizer compared to di(2-ethylhexyl)phthalate
- Author:
- Jae-Wook Lee, Seok Jong Lee, Myung Chan Gye, Eun-Yi Moon
- Year:
- 2 019
- Bibliographic source:
- Sci Rep 9, 12237
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Remarks:
- Data from Korea and not performed for REACH registration, GLP is not specified in the publication
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Triethyl O-acetylcitrate
- EC Number:
- 201-066-5
- EC Name:
- Triethyl O-acetylcitrate
- Cas Number:
- 77-89-4
- Molecular formula:
- C14H22O8
- IUPAC Name:
- triethyl 2-acetoxypropane-1,2,3-tricarboxylate
- Details on test material:
- Santa Cruz Biotechnology Inc, Dallas, TX, USA
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on species / strain selection:
- Specific pathogen-free (SPF) seven weeks old male CD-1 mice obtained from ORIENTBIO INC. (Sungnam, Republic of Korea). All animals were acclimated for 7 days and observed daily for general health.
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Five mice were housed in the transparent acrylic cage and maintained in the pathogen-free authorized facility in WOOJUNG BIO CROWISE or in Sejong University where the temperature was at 20–22 °C, the humidity at 50–60%, and a dark/ light cycle at 12 h. Mouse-used all experiments were carried out in strict accordance with the guidelines by the recommendations in the Guide for the Care and Use of Laboratory Animals of ‘Animal and Plant Quarantine Agency’, Republic of Korea.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- carboxymethylcellulose (CMC: 0.5%
- Duration of treatment / exposure:
- 24 h
- Frequency of treatment:
- 1
- Post exposure period:
- 2 h, day 1, 2 and 3
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive control group: intraperitonelly injection with 2 mg/kg MMC dissolved in saline solution.
Examinations
- Tissues and cell types examined:
- bone marrow cells from femur canal
- Evaluation criteria:
- Index of bone marrow cytotoxicity was calculated by the ratio of PCE to the total number of erythrocytes.
- Statistics:
- Criteria of Kastenbaum and Bowman was used to analyze the significant positive increase in the number of MNPCE33. Homogeneity of variance in the frequency of PCE and body weight was analyzed by using
Bartlett’s test. In addition, one-way analysis of variance (ANOVA) was employed for homogeneous data; then, if significant, Dunnett’s t-test was applied for multiple comparisons. P value of <0.05 or <0.01 was considered to
be significant.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- While no significant incidence of MNPCE in PCE was observed in groups treated with ATEC, it was significantly increased in MMC-treated group compared to control group. No statistically significant differences in the ratio of PCE among total erythrocytes were noted at 24, 48 and 72 h after administration of ATEC or MMC compared to control group.
Applicant's summary and conclusion
- Conclusions:
- ATEC did not induce micronuclei formation in PCE from mouse bone marrow under the experimental conditions.
- Executive summary:
Micronuclei formation was tested in male CD-1 mice (OECD 474). Mice were treated with 500, 1000 and 2000 mg/kg by oral gavage. Incidence of MNPCE in PCE and ratio of PCE among total erythrocytes was determined as compared to those in control group. MMC was used as a positive control.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.