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EC number: 247-569-3 | CAS number: 26266-58-0
- 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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1968
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
- Principles of method if other than guideline:
- Acute intravenous toxicity in rats.
- GLP compliance:
- no
Test material
- Reference substance name:
- Anhydro-D-glucitol trioleate
- EC Number:
- 247-569-3
- EC Name:
- Anhydro-D-glucitol trioleate
- Cas Number:
- 26266-58-0
- Molecular formula:
- C60H108O8
- IUPAC Name:
- 1,4-anhydro-2,3,6-tri-O-oleoyl-L-iditol
- Details on test material:
- - Name of test material (as cited in study report): Sorbitantrioleate
- Substance type: organic
- Physical state: amber liquid
- Analytical purity: no data
- Lot/batch No.: 4199c
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Manor Farms Research (internally continued)
- Weight at study initiation: 133-144 g (average 138 g, males), 134-164 g (average 145 g, females)
- Fasting period before study: 16 h
- Diet: ad libitum
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- propylene glycol
- Details on exposure:
- The test material was given as a 25% (w/v) dispersion in propylene glycol by hand at a rate of approximately 0.4 mL/min as tail vein infusion.
- Doses:
- 840, 891, 944 and 1000 mg/kg bw (males)
840, 891, 944, 1000, 1060, 1120, 1190 and 1260 mg/kg bw (females) - No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: 15 min, 30 min, 1, 2, 3, 4, 6, 24 and 48 h following injection
- Necropsy of survivors performed: yes, 7 days after test substance administration
- Other examinations performed: clinical signs - Statistics:
- LD50 values were calculated using the methods of Weil and Litchfield & Wilcoxon
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 875 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: at 7 days, method of Weil
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 960 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: at 7 days, method of Litchfield & Wilcoxon
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 020 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: at 7 days, method of Weil
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 050 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: at 7 days, method of Litchfield & Wilcoxon
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 943 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: at 7 days, method of Weil
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 975 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: at 7 days, method of Litchfield & Wilcoxon
- Mortality:
- In most cases death occured within ten minutes after injection but some animals died within 24 h to 48 hours after injection (details see table 1.)
- Clinical signs:
- The signs of intoxication for rats given the test substance included depression, pallor, ataxia, rapid or labored respration, and some convulsions and foam from the nose at death (for details see table 2).
- Gross pathology:
- The following tissues were examined in all animals that died after injection or were sacrificed at the end of seven days: adrenals, liver, bladder, stomach, spleen, lungs, heart, kidneys, thymus, small and large intestines. Gross pathology on rats which died after injection showed edema, hemorrhage and congestion of the lungs, congestion of the kidneys and hemorrhage in the small intestines. Rats sacrificed seven days after injection revealed no remarkable gross pathology (for details see tables 3 and 4).
Any other information on results incl. tables
Table 1: Mortalities.
Dose [mg/kg bw] |
Sex |
No. of affected animals / No. of total animals |
||
24 h |
48 h |
7 days (total) |
||
1000 |
male |
5/5 |
- |
5/5 |
944 |
2/5 |
- |
2/5 |
|
891 |
2/5 |
- |
2/5 |
|
840 |
0/5 |
- |
0/5 |
|
1260 |
female |
5/5 |
- |
5/5 |
1190 |
2/5 |
- |
2/5 |
|
1120 |
2/5 |
- |
2/5 |
|
1060 |
1/5 |
1/5 |
2/5 |
|
1000 |
3/5 |
- |
3/5 |
|
944 |
1/5 |
- |
1/5 |
|
891 |
2/5 |
- |
2/5 |
|
840 |
1/5 |
- |
1/5 |
|
1000 |
male/female |
8/10 |
- |
8/10 |
944 |
3/10 |
- |
3/10 |
|
891 |
4/10 |
- |
4/10 |
|
840 |
1/10 |
- |
1/10 |
Table 2: Clinical signs of toxicity.
Dose [mg/kg bw] |
Sex |
Sign |
No. of affected animals / No. of total animals |
Time point of observation |
1260 |
female |
pallor |
5/5 |
full dose |
1/1 |
5 – 10 min |
|||
ataxia |
5/5 |
full dose |
||
1/1 |
5 – 10 min |
|||
rapid respiration |
5/5 |
full dose |
||
1/1 |
5 – 10 min |
|||
convulsions |
1/1 (slight) |
5 min |
||
1/1 (rolling) |
death |
|||
dead |
4/5 |
5 min |
||
5/5 |
15 min |
|||
1190 |
female |
pallor |
5/5 |
full dose |
3/5 |
5 – 15 min |
|||
1/2 |
1 h |
|||
ataxia |
5/5 |
full dose |
||
3/5 |
5 – 15 min |
|||
rapid respiration |
5/5 |
full dose |
||
3/5 |
5 – 15 min |
|||
ruffed fur |
3/3 |
30 – 60 min |
||
convulsions |
2/5 (slight) |
5 min |
||
Straub tail |
2/5 |
full dose |
||
hyperactive |
2/5 |
5 min |
||
foam from nose |
2/5 |
death |
||
dead |
2/5 |
10 min |
||
1120 |
female |
pallor |
5/5 |
full dose |
3/4 |
5 min |
|||
1/3 |
10 – 30 min |
|||
ataxia |
5/5 |
full dose |
||
3/4 |
5 min |
|||
1/3 |
10 -30 min |
|||
rapid respiration |
5/5 |
full dose |
||
4/4 |
5 min |
|||
1/3 |
10 -30 min |
|||
ruffed fur |
2/3 |
10 min – 1 h |
||
hyperactive |
1/3 |
10 – 30 min |
||
dead |
1/5 |
5 min |
||
2/5 |
10 min |
|||
1060 |
female |
depression |
5/5 |
full dose |
4/4 |
5 – 30 min |
|||
pallor |
5/5 |
full dose |
||
4/4 |
5 – 30 min |
|||
1/3 |
3 days |
|||
ataxia |
5/5 |
full dose |
||
4/4 |
5 – 30 min |
|||
rapid respiration |
5/5 |
full dose |
||
4/4 |
5 - 30 min |
|||
ruffed fur |
1/3 |
3 days |
||
dead |
1/5 |
5 min |
||
2/5 |
2 days |
|||
1000 |
male / female |
depression |
10/10 |
full dose |
2/2 |
5 – 10 min |
|||
1/2 |
15 min |
|||
pallor |
10/10 |
full dose |
||
2/2 |
5 min |
|||
1/2 |
10 min |
|||
rapid respiration |
8/10 |
full dose |
||
2/2 |
5 min |
|||
1/2 |
10 min |
|||
ataxia |
10/10 |
full dose |
||
2/2 |
5 min |
|||
1/2 |
10 min |
|||
convulsions |
8/10 |
death |
||
foam from nose |
8/10 |
death |
||
dead |
8/10 |
5 min |
||
944 |
male / female |
depression |
10/10 |
full dose – 5 min |
6/10 |
10 – 15 min |
|||
pallor |
6/10 |
full dose |
||
8/10 |
5 -10 min |
|||
6/10 |
15 min |
|||
rapid respiration |
8/10 |
full dose – 5 min |
||
6/10 |
10 – 15 min |
|||
ataxia |
10/10 |
full dose |
||
6/10 |
5 – 15 min |
|||
foam from nose |
2/10 |
death |
||
dead |
2/10 |
30 min |
||
3/10 |
24 h |
|||
891 |
male / female |
depression |
10/10 |
full dose |
6/8 |
5 min |
|||
4/8 |
10 min |
|||
2/8 |
15 min |
|||
1/7 |
30 – 60 min |
|||
pallor |
8/10 |
full dose |
||
4/8 |
5 -10 min |
|||
1/8 |
15 min |
|||
rapid respiration |
9/10 |
full dose |
||
6/8 |
5 min |
|||
4/8 |
10 min |
|||
2/8 |
15 min |
|||
ataxia |
10/10 |
full dose |
||
6/8 |
5 min |
|||
4/8 |
10 min |
|||
2/8 |
15 min |
|||
foam from nose |
3/10 |
death |
||
dead |
2/10 |
5 min |
||
3/10 |
30 min |
|||
4/10 |
24 h |
|||
840 |
male / female |
depression |
10/10 |
full dose |
8/10 |
5 min |
|||
6/10 |
10 min |
|||
1/10 |
15 min – 2 h |
|||
pallor |
5/10 |
full dose |
||
9/10 |
5 min |
|||
5/10 |
5 min |
|||
1/10 |
15 – 30 min |
|||
rapid respiration |
3/10 |
full dose |
||
6/10 |
5 – 10min |
|||
1/10 |
15 – 30 min |
|||
ataxia |
10/10 |
full dose |
||
5/10 |
5 min |
|||
3/10 |
10 min |
|||
dead |
1/10 |
24 h |
Table 3: Gross pathological findings in male and female rats that died after treatment with the test substance.
Dose [mg/kg bw] |
Sex |
Organ |
No. of affected animals / No. of total animals |
Finding |
1260 |
female |
lungs |
2/5 (1/2 severe) |
hemorrhage |
3/5 (2/3 severe) |
congestion |
|||
5/5 (1/5 slight, 2/5 severe) |
edema |
|||
kidneys |
3/5 |
congested |
||
2/5 (right) |
hydronephrosis |
|||
heart |
1/5 |
enlarged, filled with clotted blood |
||
small intestine |
3/5 (1/3 severe) |
hemorrhage |
||
1190 |
female |
lungs |
1/2 |
hemorrhage |
1/2 |
severe congestion |
|||
kidneys |
1/2 |
congestion |
||
intestines |
2/2 |
hemorrhage |
||
1120 |
female |
lungs |
2/2 (1/2 severe) |
hemorrhage |
2/2 (1/2 severe) |
edema |
|||
kidneys |
1/2 |
congested medulla |
||
small intestine |
1/2 |
hemorrhage |
||
1060 |
female |
lungs |
1/2 |
severe hemorrhage |
1/2 |
severe congestion |
|||
2/2 (1/2 severe) |
edema |
|||
kidneys |
2/2 (1/2 slight) |
congested medulla |
||
small intestine |
2/2 (1/2 slight) |
hemorrhage |
||
liver |
1/2 |
possible focal capsular fibrosis |
||
spleen |
1/2 |
possible focal capsular fibrosis |
||
thymus |
1/2 |
slight congestion |
||
stomach |
1/2 |
erosion, congestion |
||
1000 |
male / female |
lungs |
6/8 (3/6 severe, 1/6 focal) |
hemorrhage |
1/8 |
slight congestion |
|||
kidneys |
4/8 (2/4 slight) |
congestion |
||
1/8 (right) |
hydronephrosis |
|||
small intestines |
2/8 |
hemorrhage |
||
liver |
3/8 |
dark |
||
1/8 |
congenital diaphragmatic hernia |
|||
944 |
male / female |
lungs |
3/3 |
hemorrhage |
3/3 (1/3 severe) |
edema |
|||
kidneys |
2/3 |
congested |
||
1/3 |
congested medulla |
|||
intestines |
2/3 |
hemorrhage |
||
liver |
1/3 |
motteled |
||
891 |
male / female |
lungs |
3/4 |
hemorrhage |
4/4 (2/4 slight,1/4 severe) |
edema |
|||
1/4 |
focal hemorrhage |
|||
kidneys |
1/4 |
congested |
||
1/4 |
slight medullary congestion |
|||
heart |
1/4 |
filled with clotted blood |
||
small intestines |
2/4 (1/2 slight) |
hemorrhage |
||
840 |
male / female |
lungs |
1/1 |
hemorrhage |
1/1 |
edema |
|||
kidneys |
1/1 |
congested |
Table 4: Gross pathological findings in male and female rats that were sacrificed 7 days after treatment with the test substance.
Dose [mg/kg bw] |
Sex |
Organ |
No. of affected animals / No. of total animals |
Finding |
1190 |
female |
lungs |
1/3 |
slight congestion |
|
|
kidneys |
1/3 |
(right) hydronephrosis |
1120 |
female |
lungs |
2/3 |
slight congestion |
|
|
kidneys |
1/3 |
(right) hydronephrosis |
1060 |
female |
lungs |
1/3 |
slight congestion |
944 |
male / female |
kidnyes |
3/7 |
(right) hydronephrosis |
891 |
male / female |
lungs |
1/6 |
slight focal hemorrhage |
|
|
kidneys |
2/6 |
(right) hydronephrosis |
840 |
male / female |
lungs |
1/9 |
slight congestion |
|
|
kidneys |
1/9 |
(right) hydronephrosis |
According to Hodge and Sterner for parenteral administration, the test item would be in the "practically non-toxic" category (0.5 - 1.5 g/kg) of materials.
Applicant's summary and conclusion
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