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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
Skin irritation/corrosion: not irritating (OECD 404, GLP)
Eye irritation: not irritating (OECD 405, GLP)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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:
- other: Guideline study with acceptable restrictions. Lack of details on test substance, lack of tabulation of individual scores and occlusive dressing.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of details on test substance, lack of tabulation of individual scores and occlusive dressing
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2312.5 g
- Housing: individual housing
- Diet: Zucht-/Haltungsdiät 20 ZH 5 (Nohrling GmbH, Bad Salzufen, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin; 2.5 cm x 2.5 cm
- Type of wrap if used: linen patch covered by a plastic foil, fixed by adhesive tapes and acrylastic band.
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Only 1 out of 4 tested animals showed a mild erythema 1 h after application. Therefore, a tabulation of the scores was not given.
- Other effects:
- No other local or systemic effects were reported.
- Interpretation of results:
- not irritating
- 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 (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 4 Mar - 11 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions. Lack of details on test substance.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb : HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2537.5 g
- Housing: animals were housed individually
- Diet: Altromin-Haltungsdiät 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 3 days
Reading time points: 1, 6, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 4
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein (0.5% aqueous solution) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibilty: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Only 1/4 animals showed slight redness of conjunctivae at 1 and 6 h after application which were fully reversible within 24 h. In 3/4 animals exsudation was observed at the 1 h reading time point. No other occular effects were observed at any timepoint in any tested animal.
- Interpretation of results:
- not irritating
- 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 (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are no data available on skin and eye irritation potential 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, 8.1 and 8.2, 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 Irritation / Corrosion data
# |
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 |
Skin irritation |
RA: CAS 102-76-1 |
Not irritating |
Eye irritation |
RA: CAS 102-76-1 |
Not irritating |
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).
No studies are available investigating the skin irritation properties 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, 8.1, 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.In a primary dermal irritation study, the skin irritation/corrosion potential of Triacetin (CAS 102-76-1) was tested similarly to OECD Guideline 404 and under GLP conditions (Kästner, 1988). The shaved dorsal skin of four adult rabbits (Kleinrusse) was exposed to 0.5 mL of the undiluted test material for 4 h under occlusive conditions. The rabbits were observed for 72 h after application. Skin reactions were assessed using the Draize scoring system. One hour after application, mild erythema was observed in 1/4 tested animals (mean erythema and edema scores out of all four animals over 24, 48 and 72 h = 0). No other skin reaction was observed in any animal at any observation time point.Thus, under the experimental conditions described, no evidence of skin irritation properties were seen after treatment with Triacetin.
No studies investigating the eye irritation properties of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin"
are available. In order to fulfil the standard information requirements set out in Annex VIII, 8.2, 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 eye irritation study was performed with Triacetin (CAS 102-76-1) similarly to OECD Guideline 405 and under GLP conditions (Kästner, 1988). 0.1 mL of the undiluted test substance was instilled into the conjunctival sac of one eye of four adult male Kleinrusse rabbits. The animals were observed for 72 h. Eye irritation was scored according to the method of Draize 1, 6, 24, 48 and 72 h after application. Only 1 out of 4 animals showed slight redness of the conjunctivae at 1 and 6 h after application which was fully reversible within 24 h. In 3 out of 4 animals exsudation was observed at the 1 h reading time point. No other eye irritation effects were observed at any time point in any tested animal. Thus the resulting mean cornea, iris, conjunctivae and chemosis scores out of all four animals over 24, 48 and 72 h were zero. Under the experimental conditions described, no evidence of eye irritation properties were seen after treatment with Triacetin.
Conclusion for skin and eye irritation
In conclusion, the tested structurally related source substance Triacetin (CAS 102-76-1) showed no skin and eye irritation potential. Therefore, based on this result, no skin or eye irritation potential for "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin" was identified.
Justification for selection of skin irritation / corrosion 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 eye irritation 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 skin and eye irritation properties 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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