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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-070-7 | CAS number: 77-93-0
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Tributyl O-acetylcitrate
- EC Number:
- 201-067-0
- EC Name:
- Tributyl O-acetylcitrate
- Cas Number:
- 77-90-7
- Molecular formula:
- C20H34O8
- IUPAC Name:
- tributyl 2-acetoxypropane-1,2,3-tricarboxylate
- Test material form:
- other: liquid
- Details on test material:
- Name of test material (as cited in study report): o-Acetyltributyl citrate
Substance type: pure active
Physical state: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Vehicle(s)/solvent(s) used: polyethylene glycol
Amount of vehicle (if gavage or dermal): 10 mL/kg bw
Purity: PEG 400 - Duration of treatment / exposure:
- 24 and 48 hours after treatment, the bone marrow cells were collected for chromosome aberration analysis
- Frequency of treatment:
- One single oral treatment
- Post exposure period:
- 24 and 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 animals (6 male and 6 female rats, 5 of each sex were evaluated)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (CPA)
- Justification for choice of positive control(s): CPA is known to induce a distinct increase in induction of aberration frequency
- Route of administration: Once oral by gavage
- Dose: 15 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow: at least 100 well spread metaphases per animals were scored for cytogenetic damage
- Evaluation criteria:
- The test item is classified as mutagenic if it induces either a dose-related increase in the number of structural chromosomal aberrations and a reproducible statistically significant positive response for at least one of the test points.
- Statistics:
- non-parametric Mann-Whitney test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- The mitotic index was slightly reduced after 24 h
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
A single dose was administered at 2000 mg/kg bw to 4 animals (2 males/2 females)
Solubility: Formulated in PEG 400
Clinical signs of toxicity in test animals: Signs recorded 1 - 48 h post-treatment. All animals showed reduction of spontaneous activity at all time points.
Evidence of cytotoxicity in tissue analyzed: The mitotic indices were slightly reduced at 2000 mg/kg bw in the main study indicating that the test item had a slight cytotoxic effect to the bone marrow
Rationale for exposure: 2000 mg/kg bw was the highest dose as required by regulatory Guidelines and expresses the MTD
RESULTS OF DEFINITIVE STUDY
Types of structural aberrations for significant dose levels: No enhancement of the aberrations frequencies
Appropriateness of dose levels and route: The single dose selected of 2000 mg/kg bw was appropriate, as it reflected the MTD and had a slight cytotoxic effect to the bone marrow after 24 h
Statistical evaluation: No significant differences for the test item as compared to the control group
Any other information on results incl. tables
Table: Experimental results
Experimental group |
Dose |
Preparation hours post administra-tion |
Number of cells scored |
% aberrant cells |
Mean mitotic index (%) |
|
PEG 400 |
0 |
24 |
1000 |
0.3 |
0.3 |
4.87 |
o-Acetytributyl citrate |
2000 |
24 |
1000 |
0.6 |
0.6 |
3.52 |
Cyclophosphamide |
15 |
24 |
1000 |
12.1*** |
11.8*** |
3.09 |
o-Acetytributyl citrate |
2000 |
48 |
1000 |
0.3 |
0.3 |
5.30 |
*** = p<0.0001
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
O-Acetyltributyl citrate did not induce chromosomal aberration in the rat in vivo - Executive summary:
A chromosomal aberration study according to OECD 475 was performed in rats in vivo after a single dose of 2000 mg/kg bw O-Acetyltributyl citrate. Five animals per sex and group, i.e. one vehicle control group, two test item groups and one positive control group were employed for the study. The test item was formulated in PEG 400. 24 and 48 h post-treatment, bone marrow cells were collected and 100 well-spread metaphases/animal were scored for chromosomal aberrations. Test item-treated animals showed reduction of spontaneous activity.
The mitotic index was slightly reduced after 24 h, but the test substance did not induce chromosomal aberrations at any time point investigated.
In contrast, the positive control substance induced a highly significant effect documenting the sensitivity of the test system. It can be assumed that the same applies to triethyl citrate (CAS 77-93-0) as it is a near analogue to the test substance acetyl tributyl citrate.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)