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EC number: 905-964-4 | 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
Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP)
Acute toxicity: Inhalation LC50 (rat, m/f): > 1.7 mg/L (OECD 403, GLP)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 17 Feb - 2 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance Triacetin (CAS No. 102-76-1). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: 120-250 g
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: animals were housed individually in polycarbonate cages with sawdust bedding.
- Diet: RMH-B (Hope Farms, Woerden, The Netherlands), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.72 mL /kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed on the day of dosing once every two hours and once daily thereafter.
- Necropsy of survivors performed: yes
- Body weight: weekly - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy revealed no substance-related findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions. Lack of details on the test substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- lack of details on the test substance
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar Bor: WISW (SPF-Cpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 160-220 g
- Housing: animals were housed in groups of 5 per Makrolon type III cage.
- Diet: Altromin 1324 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40-60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindric inhalation chamber with a baffle
- Exposure chamber volume: 20 L
- Method of holding animals in test chamber: restraining tube for head/nose-only exposure
- Source and rate of air: a compressed air supplying device (600 kPa) delivered the air at a rate of 10 L/min
- Method of conditioning air: continuous infusion pump
- System of generating particulates/aerosols: 200 µL/minute of the test substance were dispersed into the chamber
- Method of particle size determination: Aerodynamic Particle Sizer with Laser-Velocimeter (TSI-APS 3300)
TEST ATMOSPHERE
- Brief description of analytical method used: GC (FI-detector) to measure the test substance concentration (mg/m³ air)
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 100 % of the particles were ≤ 5µm
- 1054845 particles per ccm
- MMAD: 1.69 µm
Time to chamber equilibration (t95): 6 minutes - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 20 mg/L (nominal concentration)
1.7 mg/L (analytical concentration) - No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Body weights: the animals were weighed before exposure and weekly thereafter.
- Necropsy of survivors performed: yes - Statistics:
- mean values were calculated
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 721 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.721 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Body weight:
- No effect on body weight was noted.
- Gross pathology:
- There were no local irritation of the visible mucous membranes of the respiratory tract.
- Other findings:
- Air-exposed negative control animals showed no clinical symptoms during the study.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity
Justification for grouping of substances and read-across
There are no data available on the acute toxicity of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin".
In order to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance is conducted.In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical and toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Overview of Acute toxicity
# |
EC 905-964-4 |
CAS 102-76-1 |
Chemical name |
"Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin" |
Triacetin |
Molecular weight |
134.13 - 218.20 g/mol |
218.20 g/mol |
Acute toxicity oral |
RA: CAS 102-76-1 |
LD50 > 2000 mg/kg bw |
Acute toxicity inhalation |
RA: CAS 102-76-1 |
LC50 > 1.7 mg/L |
The above mentioned substances are considered to be similar on the basis of the structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for "Reaction mixture of glycerol-1,3 -
di(acetate), glycerol acetate and triacetin".
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Acute toxicity: oral
No studies are available investigating the acute toxicity via the oral route of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin".
In order to fulfil the standard information requirements set out in Annex VII, 8.5.1, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 read-across from the structurally related analogue substance Triacetin (CAS 102-76-1) is conducted.An acute oral toxicity study (limit test) with Triacetin (CAS 102-76-1) was performed according to OECD Guideline 401 and GLP (Reijnders, 1988). The test substance was administered by oral gavage at a concentration of 2000 mg/kg bw to groups of five male and female young adult Wistar rats. The animals were observed for 14 days following administration. No mortalities occurred during the study period. No clinical signs of toxicity and no changes in body weight were reported. Necropsy at the end of the 14-day study period did not reveal any substance related findings. The acute oral LD50 was found to be greater than 2000 mg/kg bw for Triacetin.
Acute toxicity: inhalation
No studies are available investigating the acute toxicity via the inhalation route of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin".
In order to fulfil the standard information requirements set out in Annex VIII, 8.5.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 read-across from the structurally related analogue substance Triacetin (CAS 102-76-1) is conducted.An acute nose/head only inhalation toxicity study was performed with Triacetin (CAS 102-76-1) similarly to OECD Guideline 403 and under GLP conditions (Pauluhn, 1985). Five male and five female Wistar rats were exposed for 4 hours to the maximum attainable Triacetin aerosol concentration of 1.7 mg/L (analytical concentration). The nominal concentration used in this study was 20 mg/L. Samples taken from the breathing zone were used to measure the actual Triacetin concentration. 100 % of the aerosol particles were found to be smaller than 5 µm and the MMAD was 1.69 µm. All treated animals survived and no signs of systemic toxicity were observed throughout the 14-day observation period. No local irritation of the visible mucous membranes of the respiratory tract was seen at gross pathology analysis. The acute inhalatory LC50 in rats was found to be greater than the maximum attainable aerosol concentration of 1.7 mg/L Triacetin. This concentration is above the maximum saturated vapour concentration of Triacetin, which is 0.5986 mg/L at 20°C.
Conclusion for acute toxicity
In summary, one acute oral toxicity study conducted with the source substance Triacetin (CAS 102-76-1) showed no effects and resulted in an oral LD50 value greater than 2000 mg/kg bw. A read-across study from Triacetin (CAS 102-76-1) investigating the acute toxicity via inhalation showed no effects of toxicity, as well. The LC50 value for rats was found to be greater than the maximum attainable aerosol concentration of 1.7 mg/L. Thus, the available data indicated a very low level of acute toxicity for
"Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin" and therefore, no hazard for acute oral and inhalative toxicity was identified.
Justification for selection of acute toxicity – oral endpoint
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details)
Justification for selection of acute toxicity – inhalation endpoint
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details)
Justification for classification or non-classification
Based on read-across from the source substance Triacetin following an analogue approach, the available data on acute and inhalation toxicity of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin"
do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and the data are therefore conclusive but not sufficient for classification.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.
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