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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | CAS number: -
- 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
Description of key information
Not toxic by the oral or dermal routes of exposure
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1958
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- An analogue approach is used for the hazard assessment of several human health endpoints. The hypothesis for the analogue approach is that data can be read-across from data-rich substances, namely acetyl tributyl citrate (ATBC, CAS 77-90-7), acetyl triethyl citrate (CAS 77-89-4) and triethyl citrate (TEC, CAS 77-93-0) to acetyl trihexyl citrate (ATHC, CAS 24817-92-3). The analogue approach is based on common breakdown products via physical and biological processes, and similar functional groups, according to Annex XI, Section 1.5, of Regulation EC No. 1907/2006. Read-across to ATHC is indicated in order to avoid unnecessary in vivo testing according to Article 25 of Regulation EC No. 1907/2006.
The analogue approach to evaluating the safety of triethyl citrate is adopted here, reflecting the approach used by various expert panels and authoritative bodies in their safety assessment of TEC, included JECFA, EFSA, U.S. FDA, EPA and CIR. The use of analogues for hazard evaluation is justified (Scenarios 1 and 2 of the RAAF, 2015) because the substances have common breakdown products via physical and biological processes, which reflects the similar functional groups in their chemical structure. The proposed analogues have similar functional groups, including: a citric acid (tricarboxylic acid) backbone, three short-chain alkyl esters, and an acetyl group (except for TEC). Other than the acetyl group, there are no other functional groups which may introduce additional toxicities. The substances display similar classification based on similar toxicities.
The target substance is expected to have essentially the same effect in the toxicity test/endpoint as does the source substance. Dose descriptors obtained for derivation of a DNEL are adequate and appropriate, and do not underestimate the hazards of the registered substance.
This information is adequate to fulfill the data requirements of Annex IX, to be the basis for classification and labelling decisions, and for risk assessment. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Predates establishment of OECD guideline and GLP. Standard acute oral gavage dosing of rats with 21 day observation period.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Administered via oral gavage at 10-30 ml/kg bw.
- Doses:
- 10 - 30 g/kg bw, equivalent to 10,000 to 30,000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- Observation for 21 days after dosing
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- LD50 may be as high as 30000 mg/kg bw
- Mortality:
- No deaths
- Clinical signs:
- other: Leakage of the material from the rectum. Animals appeared somewhat sluggish but recovered promptly, showing no signs suggesting systemic toxicity in the ensuing 3 weeks.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study of acute oral toxicity in 5 Wistar rats, the analogue test material was given via gavage at doses between approximately 10,000 and 30,000 mg/kg bw. No lethality or toxicity was observed. The LD50 is > 10,000 mg/kg bw. These data are applicable to the target substance, and are adequate for the purposes of risk assessment and classification and labeling
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 000 mg/kg bw
- Quality of whole database:
- adequate
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Judged to be scientifically reliable and appropriate for risk assessment by the Expert Panel of dermatologists and scientists at the Cosmetics Ingredient Review, Washington, DC., U.S.A.
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.3
- Version / remarks:
- compliant with U.S. CPSC
- Principles of method if other than guideline:
- This summary data provided in a peer-reviewed publication reflects the opinion of the CIR Expert Panel that the test data are valid and informative. The study was commissioned by the Cosmetics, Toiletries and Fragrance Association (CTFA), now the Personal Care Products Council (PCPC), which generally selects OECD-compliant protocols (or FDA protocols which are aligned with OECD guidelines) and requires execution of the study under GLP.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Purity > 99% ATHC, Volatiles 1.4%.
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Female albino rabbits were divided equally into two groups (intact and abraded test sites, respectively). The mean body weight was 2.29 for one group (intact) and 2.81 kg (abraded sites) for the other group.
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Skin in one group of animals is abraded, skin of the other group is intact. The test material is applied on gauze and covered with an occlusive dressing for 24 h.
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw (2 g/kg).
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not required
- Details on study design:
- The animals are observed after the application and at least once daily. The obsrvation period is 14 days. Animals are euthanised at 14 days, and necropsied are undertaken.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No dealths occurred.
- Clinical signs:
- other: No clinical signs of systemic toxiicty.
- Gross pathology:
- No changes were observed in any of the animals tested.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was tested in an acute dermal toxicity study in 10 male/female rabbits at doses of 2000 mg/kg bw. Within the 14-day observation period, there were no deaths or clinical effects among the animals. The LD50 is > 2000 mg/kg bw. The substance does not meet the criteria for classification for acute oral toxicity according to Regulation EC No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- adequate
Additional information
Justification for classification or non-classification
In oral and acute dermal acute toxicity tests, the substance showed LD50s > 2000 mg/kg bw. The substance does not meet the criteria for classification for acute toxicity under Regulation EC No. 1272/2008.
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.