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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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 SIDS
- 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:
- other: 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
- Physical state: colourless clear liquid with slight odour
- Source: Daihachi Chemical Industry. Co., Ltd.
- Analytical purity: > 98.2 %
- Lot/batch No.: N-80302
- Stability under test conditions: Stability confirmed during use by gas chromatography.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj: CD(SD) IGS
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: (P) 9 weeks
- Weight at study initiation: (P) Males: 371-375 g; Females: 203-240 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 3 % gum arabic in purified water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: up to 7 days
- Proof of pregnancy: vaginal plug or sperm in vaginal smear - Duration of treatment / exposure:
- 44 days (males) from 2 weeks prior to mating.
41-48 days (females) from 14 days before mating to day 3 postpartum. - Frequency of treatment:
- daily
- Duration of test:
- Day 14 before mating to Day 3 postpartum
Doses / concentrations
- Remarks:
- Doses / Concentrations:
40, 200 and 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: The general condition was observed once a day.
BODY WEIGHT: Yes
- Time schedule for examinations: Body weight was determined on Day 0, 3, 7 and 14 of administration and once a week thereafter. For pregnant females, body weight was determined on the Day 0, 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.
HISTOPATHOLOGY / ORGAN WEIGHTS
Microscopic: all animals in control and 1,000 mg/kg bw 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.
Organ weight: for both sexes, brain, pituitary gland, thyroid gland, heart, liver, kidney, spleen, adrenal, thymus, and in addition for males, testes and epididymis.
OTHER:
Haematology and biochemistry for males conducted only at time of necropsy after 44 days of exposure (for further details refer to 7.5.1 Repeated dose toxicity). - Ovaries and uterine content:
- - Number of corpora lutea: Yes
- Number of implantations: Yes - Fetal examinations:
- Numbers of offspring or live offspring, the sex ratio, the live birth index, the viability index and body weights, external features, clinical signs and necropsy.
Gross necropsy consisted of external and internal examination. - 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, Chi-square was used. If a significant difference was observed, Chi-square of Armitage test 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.
- Indices:
- Copulation index (%): Number of copulated females/number of pairs x 100
Fertility Index (%): Number of pregnant females/numer of copulated females x 100
Gestation index (%): Number of pregnant animals delivered live offspring/ numer of pregnant animals x 100
Delivery index (%) and implantation index (%) were given.
The gestation index, gestation length, parturition and maternal behavior. Effects at gross pathology and microscopic evaluation of the reproductive organs.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
CLINICAL SIGNS AND MORTALITY (PARENTAL ANIMALS)
No dose-related changes in general clinical signs. One male at 1000 mg/kg bw/day was dead 32 days after the administration started.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
For both sexes, no statistically significant difference from controls was observed in body weight and body weight gain during administration period. For both sexes, no statistically significant difference from controls was observed in food consumption during administration period.
ORGAN WEIGHTS (PARENTAL ANIMALS)
No dose-related changes in organ weight were observed.
GROSS PATHOLOGY (PARENTAL ANIMALS)
No changes in gross pathology in both sexes were observed.
HISTOPATHOLOGY (PARENTAL ANIMALS)
Tissue pathology revealed no alteration of tissues even in the highest dose groups for both sexes.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
On examination of neonates, there were no significant differences in numbers of offspring or live offspring, the sex ratio, the live birth index, the viability index or body weights. No abnormal findings ascribable to the compound were found for external features, clinical signs or necropsy of the offspring. One dead offspring showed pyelectasis at dosing of 40 mg/kg bw/day.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1. Delivery data (P).
Parameter [mean] |
Group 1 0 mg/kg bw |
Group 2 40 mg/kg bw |
Group 3 200 mg/kg bw |
Group 4 1000 mg/kg bw |
Number of corpora lutea |
16.6 |
16.3 |
16.3 |
16.8 |
Number of Implantations sites |
15.3 |
16.0 |
14.7 |
15.8 |
Total number of offsping |
14.4 |
15.3 |
14.3 |
14.6 |
Implantation Index (%) |
90.15 |
98.17 |
89.49 |
93.84 |
Delivery Index (%) |
94.83 |
95.11 |
90.17 |
92.62 |
Gestation Index (%) |
100 |
100 |
91.7 |
100 |
Table 2. Litter size and viability index (F1).
Parameter |
Group 1 0 mg/kg bw |
Group 2 40 mg/kg bw |
Group 3 200 mg/kg bw |
Group 4 1000 mg/kg bw |
Total number of offspring at birth |
14.4 |
15.3 |
15.6 |
14.6 |
Total number of live offspring at birth |
14.2 |
15.3 |
15.5 |
14.6 |
Number of live offspring on Day 4 |
14.1 |
14.8 |
15.2 |
14.5 |
Viability index (%) Day 0 Day 4 |
98.71 99.38 |
100 97.17 |
98.86 98.3 |
100 99.41 |
Applicant's summary and conclusion
- Conclusions:
- The test substance had no effect on intrauterine development.
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