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EC number: 208-686-5 | CAS number: 538-23-8
- 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:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- No soft tissue and head examinations were performed in foetuses.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 970
- Reference Type:
- secondary source
- Title:
- Final report on the safety assessment of Trilaurin, Triarachidin, Tribehenin, Tricaprin, Tricaprylin, Trierucin, Triheptanoin, Triheptylundecanoin, Triisononanoin, Triisopalmitin, Triisostearin, Trilinolein, Trimyristin, Trioctanoin, Triolein, Tripalmitin
- Author:
- Cosmetic Ingredient Review (CIR)
- Year:
- 2 001
- Bibliographic source:
- Int J Toxicol. 2001;20 Suppl 4:61-94
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A teratogenicity study in mice was conducted in 1970, prior to any OECD guideline adoption.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Glycerol trioctanoate
- EC Number:
- 208-686-5
- EC Name:
- Glycerol trioctanoate
- Cas Number:
- 538-23-8
- Molecular formula:
- C27H50O6
- IUPAC Name:
- 1,3-bis(octanoyloxy)propan-2-yl octanoate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: ICR-JCL
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-8 weeks
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 55-60
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1.2% Tween 80/0.8% Span 80 in water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was mixed with 1.2% (w/v)Tween 80 and 0.8% (w/v) Span 80 in water. The emulsion was prepared with Manton Gaulin Homgenizer.
VEHICLE
- Justification for use and choice of vehicle: low water solubility - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- No detailed information is available.
- Duration of treatment / exposure:
- Day 7-12 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- Day 18 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 908 mg/kg bw/day (actual dose received)
- Remarks:
- 2 mL/kg; calculated based on a density value of 0.954 g/mL
- Dose / conc.:
- 9 540 mg/kg bw/day (actual dose received)
- Remarks:
- 10 mL/kg; calculated based on a density value of 0.954 g/mL
- No. of animals per sex per dose:
- 20 parental females
- Control animals:
- other: physiological saline or soybean oil
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: on Days 0, 7 and 18 of gestation - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: No - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: No
- Skeletal examinations: Yes: all per litter
- Head examinations: No
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No differences were observed between test substance administration group, control group and soybean oil administration group.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 9 540 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity: no adverse effects
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- not examined
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
External abnormalities: cleft palate was observed in 1 foetus of control, 1 foetus of the 2 mL/kg bw/day dose group and 3 foetuses of the 10 mL/kg bw/day dose group. No cleft palate was found in foetuses receiving soybean oil. Club foot was observed in 1 foetus of control, 4 foetuses of the soybean oil control group, 3 foetuses of the 2 mL/kg bw/day dose group and 4 foetuses of the 10 mL/kg bw/day dose group.
Skeletal abnormalities: Two foetuses showed assimilation of the ribs in the 2 mL/kg bw/day dose group. One foetus showed assimilation of the cervical vertebra in the 10 mL/kg bw/day dose group. However, these effects did not follow a clear dose-dependency.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 9 540 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: teratogenicity: no adverse effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1. Effects on foetuses of parental females treated with the test substance (2 and 10 mL/kg) and soybean oil
Groups |
No of mothers |
No. of fetuses |
Live fetuses |
Dead |
|||||
No. |
Mean body weight (g) |
No. of resorbed fetuses |
No. of dead fetuses |
Total (%) |
|||||
M. |
F. |
M.+F. |
|||||||
Control (saline) |
20 |
232 (11.6 ± 0.39) |
116 |
104 |
220 |
1.28 ± 0.023 |
11 |
1 |
12 (5.2) |
Soybean oil |
20 |
223 (11.1 ± 0.46) |
101 |
114 |
215 |
1.26 ± 0.021 |
6 |
2 |
8 (3.6) |
2 mL/kg |
20 |
231 (11.5 ± 0.29) |
113 |
107 |
220 |
1.29 ± 0.023 |
9 |
2 |
11 (4.8) |
10 mL/kg |
20 |
232 (11.6 ± 0.40) |
107 |
112 |
219 |
1.26 ± 0.030 |
12 |
1 |
13 (5.6) |
M.: male, F.: female
(Mean ± standard error)
Table 2. Malformations in foetuses of parental females treated with the test substance (2 and 10 mL/kg) and soybean oil
Group |
Malformed |
||
No. (%) |
Number of fetuses: Type |
||
Ex |
Sk |
||
Control (saline) |
3 (1.4) |
0 |
1: Curled tail 1: Cleft palate 1: Club foot |
Soybean oil |
4 (1.9) |
0 |
4: Club foot |
2 mL/kg |
4 (1.8) |
2 (0.9) |
1: Cleft palate 3: Club foot 2: Assimilation of the ribs |
10 mL/kg |
7 (3.2) |
1 (0.5) |
3: Cleft palate 4: Club foot 1: Assimilation of the cervical vertebra |
Ex: external malformation
Sk: skeletal malformation
Applicant's summary and conclusion
- Conclusions:
- CLP/EU GHS criteria not met, no classification required according to 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.
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