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EC number: 297-083-0 | CAS number: 93334-10-2
- 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:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (non-GLP, limited documentation, no opthalmoscopy and neurobehavioural examination, 15 animals/dose group, no NOAEL identified).
Data source
Reference
- Reference Type:
- publication
- Title:
- Short-term toxicity study of sorbitan monolaurate (Span 20) in rats
- Author:
- Cater, B.R. et al.
- Year:
- 1 978
- Bibliographic source:
- Food Cosmet Toxicol 16(6): 519-26
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- (non-GLP, limited documentation, no opthalmoscopy and neurobehavioural examination, 15 animals/dose group)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sorbitan laurate
- EC Number:
- 215-663-3
- EC Name:
- Sorbitan laurate
- Cas Number:
- 1338-39-2
- Molecular formula:
- C18H34O6
- IUPAC Name:
- 1,4-anhydro-6-O-dodecanoyl-D-glucitol
- Details on test material:
- - Physical state: oily liquid
- Analytical purity: approx. 95%
- Impurities (identity and concentrations): water (max. 1%), sulphated ash (max. 0.25%), arsenic (max. 3 ppm), lead (max. 10 ppm), copper (max. 50 ppm), zinc (max. 25 ppm)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A. Tuck & Son, Rayleigh, Essex
- Housing: 5 per cage
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The animals were fed a diet (ground Spratts Laboratory Diet No.1) containing the test substance.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- continuously (via diet)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2100, 4200, 8000 mg/kg bw/day
Basis:
other: mean intake of test compound, males
- Remarks:
- Doses / Concentrations:
2300, 4500, 8400 mg/kg bw/day
Basis:
other: mean intake of test compound, females
- Remarks:
- Doses / Concentrations:
2.5, 5.0, 10.0 %
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- The animals were weighed and the food and water intakes of each cage was measured weekly.
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE :
- Food consumption for each cage was determined and mean daily diet consumption calculated as g food/kg body weight/day
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 2, 6, and 13 weeks
- Anaesthetic used for blood collection: Yes (at 13 weeks collection): barbiturate anaesthesia
- Animals fasted: no
- How many animals: all
- Parameters examined: haemoglobin, packed cell volume, counts of erythrocytes, reticulocytes and total and differential white blood cells
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at 6 and 13 weeks of treatment (females: all parameter after 6 and 13 weeks, males: total protein, albumin only after 13 weeks)
- Animals fasted: no
- How many animals: all
- Parameters examined: total protein, albumin, activity of glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase and lactic dehydrogenase
URINALYSIS: Yes
- Time schedule for collection of urine: 6 h period during the final week
- Animals fasted: no
- Parameters examined: albumin, glucose, ketones, bile salts, blood - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
brain, pituitary, thyroid, heart, liver, spleen, kidneys, adrenal glands, gonads, stomach, small intestine, caecum
HISTOPATHOLOGY: Yes
brain, pituitary, thyroid, heart, liver, spleen, kidneys, adrenal glands, gonads, stomach, small intestine, caecum, lung, salivary gland, aortic arch, thymus, various lymph glands, urinary bladder, colon, rectum, pancreas, uterus, skeletal muscle - Other examinations:
- Measurement of specific gravity and volume of urine:
6 h period of water deprivation
2 h period following a water load (25 ml/kg)
4 h period following a 16 h period of water deprivation - Statistics:
- Student´s t-test for body and organ weights and White (1952) test for food consumption
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- decreased body weights at 5 and 10%
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- lower food consumption
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- increase in mid dose group males, decrease in high dose females
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Hb, erythrocyte cound, reticulocyte counts changed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- increased liver and kidney weights
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- increase of periportal fat at 5 and 10%
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No deaths or abnormal behaviour was seen.
BODY WEIGHT AND WEIGHT GAIN
Decreased body weights were seen in the 5 or 10% group after 48 h of start of treatment (-19 and -32%, respectively) and remained less until the end of the study (-19 and -27%, respectively), see Table 1. The effect was detectable, but less marked in the 2.5% group (statistically significant after 6-9 days of treatment, about 10%).
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
The average food intake was lower over the treatment period, related to the dietary concentration of the test substance (see Table 1).
Paired-feeding study:
Body weights of treated animals were lower than those of the pair-fed controls. The differences were less than with the ad. lib. controls.
HAEMATOLOGY
Haemoglobin concentration and packed cell volume was decreased in all groups and both sexes in a dose dependent manner beginning with the second week of the study period (see Table 2). Red blood cell counts were decreased at the lower treatment levels, but increased at the highest treatment level, beginning with week 6 in booth sexes. A tendency for increased reticulocyte counts and decrease in total leucocyte counts was seen in both sexes.
CLINICAL CHEMISTRY
Results were similar in the test and the control animals.
WATER CONSUMPTION AND COMPOUND INTAKE
An increase in mid dose group males and a decrease in high dose females was observed for water consumption over the hole study period.
URINALYSIS
There was a tendency for the treated male rats to produce less urine with a higher specific gravity.
ORGAN WEIGHTS
Absolute weights of brain, heart, parts of gastro-intestinal tract and testes were unchanged or decreased, but relative organ weight was increased in treated groups (see Table 3). Spleen weights were decreased, with unchanged relative organ weight. Absolute and relative liver weights in males and females were increased (10% group). Absolute kidney weights were increased (5, 10% group), relative kidney weights were increased in all dose groups.
Paired-feeding study:
Liver and kidney weights were significantly increased. Relative organ weights of those organs, as well as of heart and small intestine were increased.
HISTOPATHOLOGY: NON-NEOPLASTIC
Periportal vacuolation was observed in the livers in the highest dose group. An increase of periportal fat was determined in females (5, 10% group) and males (10% group). Early nephrosis was observed in test and control animals.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Due to the high dose levels administered, no NOAEL but only a LOAEL can be determined.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Dose descriptor:
- LOAEL
- Effect level:
- 2 300 other: mg/kg bw/day: mean intake of test compound
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: effects on body weight, food consumption, haematology, organ weights and histopathology
- Dose descriptor:
- LOAEL
- Effect level:
- 2 100 other: mg/kg bw/day: mean intake of test compound
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: effects on body weight, food consumption, haematology, organ weights and histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Mean data body weights and on food consumption and resulting intake of test substance
|
|
Body weight (g) at day |
Food consumption (g/rat/day) at day |
|
|
||||||||
Diet |
Dietary level (%) |
0# |
1 |
27 |
55 |
90 |
0# |
1 |
27 |
55 |
90 |
Mean food consumption (g/rat/day) |
Mean intake of test compound |
Males |
|||||||||||||
Control |
0 |
86 |
93 |
263 |
371 |
432 |
13.3 |
14.5 |
21.3 |
22 |
18.9 |
20.2 |
0 |
Test substance |
2.5 |
85 |
87 |
238** |
332** |
389** |
10.7 |
13.3 |
19.2 |
19.4 |
17.5 |
18.5* |
2.1 |
|
5 |
85 |
86 |
214*** |
294*** |
350*** |
9.6 |
10.1 |
16.4 |
18.7 |
17.8 |
16.9*** |
4.2 |
|
10 |
84 |
81** |
179*** |
263*** |
316*** |
7.5 |
7.8 |
16 |
17.1 |
15.9 |
15.4*** |
8 |
Females |
|||||||||||||
Control |
|
69 |
75 |
176 |
221 |
250 |
10.5 |
11.7 |
15.7 |
16.3 |
13.7 |
15.3 |
0 |
Test substance |
2.5 |
71 |
73 |
162** |
205* |
233 |
9.1 |
9.3 |
13.1 |
15.5 |
14.7 |
14.7 |
2.3 |
|
5 |
71 |
70* |
152*** |
198** |
225** |
7.3 |
6.8 |
12.9 |
15.5 |
14.3 |
13.6* |
4.5 |
|
10 |
71 |
68** |
141*** |
172*** |
191*** |
4.6 |
5.9 |
11.7 |
12.8 |
12.3 |
11.8*** |
8.4 |
#: pretreatment value on day 1 of study
*p<0.05, **p<0.01, ***p<0.0001
Table 2: Mean haematological findings after 2, 6 or 13 weeks
Leucocytes |
||||||||||
|
|
|
|
|
|
|
Differential (%) |
|||
Sex and diet |
Dietary level |
Hb (g/100 mL) |
PCV (%) |
RBC (106/mm³) |
Retics (% of RBC) |
Total (103/mm³) |
N |
E |
L |
M |
Week 2 |
||||||||||
Male |
|
|
|
|
|
|
|
|
|
|
Control |
0 |
14.4 |
44 |
6.7 |
3.4 |
6.7 |
11 |
1 |
87 |
1 |
Test substance |
5 |
13.6* |
41* |
6.6 |
1.5** |
5.6 |
12 |
1 |
86 |
1 |
|
10 |
13** |
41* |
7.5 |
4.4 |
5.5 |
14 |
1 |
84 |
1 |
Female |
|
|
|
|
|
|
|
|
|
|
Control |
0 |
14.7 |
44 |
7 |
1.9 |
5 |
16 |
1 |
82 |
1 |
Test substance |
5 |
14.2 |
41* |
6.7 |
1.1 |
3.9 |
11 |
0 |
88 |
1 |
|
10 |
13*** |
40** |
6.3* |
2.7 |
3.4 |
11 |
0 |
88 |
1 |
Week 6 |
||||||||||
Male |
|
|
|
|
|
|
|
|
|
|
Control |
0 |
15.6 |
47 |
7.2 |
1.2 |
5.3 |
11 |
1 |
87 |
1 |
Test substance |
5 |
14** |
42** |
6.9 |
0.8* |
5 |
8 |
0 |
91 |
1 |
|
10 |
13.2*** |
41** |
8.5* |
2.4** |
4.4 |
14 |
1 |
84 |
1 |
Female |
|
|
|
|
|
|
|
|
|
|
Control |
0 |
15 |
44 |
7.1 |
0.7 |
5.3 |
13 |
1 |
85 |
1 |
Test substance |
5 |
13.9*** |
41* |
6.5* |
0.6 |
4 |
12 |
2 |
85 |
1 |
|
10 |
14.2* |
41 |
8* |
1 |
4.4 |
12 |
0 |
88 |
0 |
Week 13 |
||||||||||
Male |
|
|
|
|
|
|
|
|
|
|
Control |
0 |
15.3 |
45 |
8 |
0.3 |
6 |
14 |
1 |
84 |
1 |
Test substance |
2.5 |
15.2 |
44 |
7.2* |
0.6 |
4.4** |
18 |
1 |
80 |
1 |
|
2.5 |
14.2** |
43** |
7.1* |
0.7* |
4.6* |
16 |
1 |
81 |
2 |
|
10 |
13.7*** |
41*** |
8.2 |
0.9* |
4.8* |
16 |
1 |
83 |
1 |
Female |
|
|
|
|
|
|
|
|
|
|
Control |
0 |
14.6 |
45 |
7 |
0.9** |
3.7 |
17 |
1 |
81 |
1 |
Test substance |
2.5 |
14.8 |
45 |
7.2 |
0.7 |
3.7 |
14 |
|
84 |
1 |
|
5 |
14** |
42** |
7 |
0.7 |
3.6 |
13 |
1 |
85 |
1 |
|
10 |
12.3*** |
39*** |
8.1** |
0.8 |
4.2 |
15 |
1 |
82 |
2 |
*p<0.05, **p<0.01, ***p<0.0001
Hb: Haemoglobin, PCV: Packed cell volume, RBC: Red blood cells, Retics: Reticulocytes, N: Neutrophils, E: Eosinophils, L: Lymphocytes, M: Monocytes
Table 3: Mean relative organ weights (g/100g body weight) of rats feed the test diets after 13 weeks
Sex and diet |
Dietary level |
Brain |
Heart |
Liver |
Kidneys |
Adrenals# |
Gonads$ |
Pituitary# |
Thyroid# |
Terminal body weight (g) |
Male |
|
|
|
|
|
|
|
|
|
|
Control |
0 |
0.46 |
0.25 |
2.51 |
0.56 |
12.8 |
0.94 |
2.2 |
3.5 |
418 |
Test substance |
2.5 |
0.51* |
0.27 |
2.38 |
0.63*** |
15.9** |
0.98 |
2.3 |
3.9 |
377** |
|
5 |
0.55*** |
0.28 |
2.54 |
0.75*** |
15.7* |
1.05 |
2.3 |
3.7 |
338*** |
|
10 |
0.6*** |
0.31*** |
3.67*** |
0.71*** |
14.5 |
1.15*** |
2.6* |
4 |
305*** |
Female |
|
|
|
|
|
|
|
|
|
|
Control |
0 |
0.72 |
0.3 |
2.5 |
0.6 |
25.8 |
47.1 |
4.9 |
4.9 |
245 |
Test substance |
2.5 |
0.78* |
0.31 |
2.44 |
0.69*** |
26.5 |
48.5 |
4.8 |
4.5 |
227* |
|
5 |
0.79* |
0.32 |
2.67 |
0.88*** |
29 |
47.9 |
4.5 |
5.3 |
221** |
|
10 |
0.9*** |
0.35*** |
4.39*** |
0.97*** |
25.7 |
50.4 |
4.3 |
5.6 |
190*** |
*p<0.05, **p<0.01, ***p<0.0001
#: Weights of this organs are express in mg/100 bw
$: Weights of female gonads are expressed in mg/100 g bw
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.