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Diss Factsheets
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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- 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: 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.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Reference Type:
- secondary source
- Title:
- Triacetin CAS No. 102-76-1
- Author:
- OECD
- Year:
- 2 002
- Bibliographic source:
- SIDS Initial Assessment Report For SIAM 15
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Triacetin
- EC Number:
- 203-051-9
- EC Name:
- Triacetin
- Cas Number:
- 102-76-1
- Molecular formula:
- C9H14O6
- IUPAC Name:
- propane-1,2,3-triyl triacetate
- Details on test material:
- - Name of test material (as cited in study report): Triacetin
- Source: Daihachi Chemical Industry. Co., Ltd.
- Physical state: colourless clear liquid with slight odour
- Analytical purity: > 98.2 %
- Lot No.: N-80302
- Stability under test conditions: Stability during use confirmed by gas chromatography.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj: CD (SD) IGS
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 weeks
- Weight at study initiation: 317-375 g (males) and 203-240 g (females)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 31-62
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 3% gum arabicum in purified water
- Details on oral exposure:
- Dosing volume: 5 mL/kg bw
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 44 days from 14 days prior to mating (males)
41-48 days from 14 days before mating to day 3 postpartum (females) - Frequency of treatment:
- once daily, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
40, 200, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: on Day 0, 3, 7 and 14 of administration and once a week thereafter. For pregnant females, body weight was determined on Day 0, 7, 14 and 20 of gestation and on Day 0 and 4 of lactation.
FOOD CONSUMPTION: Yes
- Food consumption was determined on the same day when body weight was measured for 24 h.
HAEMATOLOGY: Yes
- Time schedule for examinations: at time of necropsy after 44 days of chemical exposure (males).
- Parameters checked: red blood cell count, haemoglobin, haematrocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocyte ratio, platelets, white blood cell count, lymphocyte, neutrophilic segmented, neutrophilic band, eosinophil-, basophil-, monocyte-value.
CLINICAL CHEMISTRY: Yes
- Time schedule for examinations: at time of necropsy after 44 days of chemical exposure (males).
- Parameters checked: aspartate aminotransferase, alanine aminotrasferase, gamma glutamyltransferase, nitrophenylphosphate, total bilirubin, urea nitrogen, creatinine, glucose, total cholesterol, triglycerides, total protein, albumin, A/G ratio, calcium, inorganic phophorus, Na, K, Cl. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organs examined at necropsy: organ weight for both sexes, brain, pituitary gland, thyroid gland, heart, liver, kidney, spleen, adrenal, thymus and in addition for males, testes and epididymis.
HISTOPATHOLOGY: Yes
All animals in control and in the high dose group and unfertilized animals in other groups: brain, spinal cord, pituitary gland, eyeball, thyroid
gland (including parathyroid gland), thymus, heart, trachea, lung, liver, kidney, adrenal, spleen, stomach, small intestine, large intestine, pancreas,
urinary bladder, bone marrow, sciatic nerve, lymph node, testes, epididymis, prostate, seminal vesicle, ovary, uterus, vagina, mammary gland and any organs, which might be expected to have histopathological changes and thymus and lung of dead animals. - Statistics:
- Regarding quantitative data (body weight, gain of body weight, food consumption, organ weight, haematology, clinical chemistry, number of corpora lutea, number of implantation sites and total number of offspring), Bartlett test was used. In case of equal variance and unequal variance, ANOVA and Kruskal-Wallis test was applied, respectively. If there was a significant difference, Dunnett test or Dunnett multiple-comparison was used.
For day of conceiving, number of estrus, gestation length, implantation index, delivery index, viability index at Day 0 and Day 4, Bartlett test and Kruskal-Wallis test was used. If a significant difference was found, Dunnett multi-comparison test was applied.
For histopathology findings, the Chi-square test was used. If a significant difference was observed, Chi-square of Armitage was used between control and administration group. Regarding copulation index, fertility index, gestation index and sex ratio of offspring was tested with Fisher’s exact test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No clinical signs of toxicity observed. One male at 1000 mg/kg bw/day was dead 32 days after the administration started.
BODY WEIGHT AND WEIGHT GAIN
No effects were observed.
FOOD CONSUMPTION AND COMPOUND INTAKE
No effects were observed.
HAEMATOLOGY
In males a decrease in differential leukocyte count (%) in neutrophils (band) at 40 (p < 0.05) and 1000 mg/kg bw/day (p < 0.01) was observed, which was within physiological changes.
CLINICAL CHEMISTRY
In males a decrease in creatinine at 40 (p < 0.01) and 1000 mg/kg bw/day (p < 0.01) was observed, which was within physiological changes. An increase in inorganic phosphorus at 200 mg/kg bw/day (p < 0.05) was apparent, but with no dose-related changes.
ORGAN WEIGHTS
No changes were observed.
GROSS PATHOLOGY
No changes were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
No changes were observed.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.