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EC number: 604-610-3 | CAS number: 147858-26-2
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-12-14 to 2018-01-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt fuer Gesundheit und Lebensmittelsicherheit (05.06.2015)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of 2-O-α-L-Rhamnopyranosyl-α-L-rhamnopyranosyl-β-hydroxydecanoyl-β-hydroxydecanoic acid and α-L-Rhamnopyranosyl-β-hydroxydecanoyl-β-hydroxydecanoic acid
- EC Number:
- 604-610-3
- Cas Number:
- 147858-26-2
- IUPAC Name:
- Reaction mass of 2-O-α-L-Rhamnopyranosyl-α-L-rhamnopyranosyl-β-hydroxydecanoyl-β-hydroxydecanoic acid and α-L-Rhamnopyranosyl-β-hydroxydecanoyl-β-hydroxydecanoic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Storage condition of test material:
2-8 °C; in closed packaging
- Final preparation of a solid: In order to get the test item in a solution or suspension, which is applicable to the animals, aqua ad injectionem was evaluated as vehicle and was considered to be adequate. The dose formulations were made shortly before each dosing occasion. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Step 1, animal no. 1 - 3: 8 - 9 weeks; Step 2, animal no. 4 - 6: 9 - 10 weeks
- Weight at study initiation: Step 1, animal no. 1 - 3: 153 - 169 g; Step 2, animal no. 4 - 6: 161 - 172 g
- Fasting period before study: Prior to the administration food was withheld from the test animals for 18 to 19 hours (access to water was permitted).
- Housing: IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: Adequate acclimatisation period (at least five days) under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The vehicle aqua ad injectionem was chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): Aqua ad injectionem (DELTAMEDICA, lot no. 705820, expiry date: 30/04/2020).
- Purity: not specified
MAXIMUM DOSE VOLUME APPLIED: a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6 female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded. The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation. - Statistics:
- no data
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- cut-off
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item showed mortality in 1 of 6 animals and acute oral toxicity characteristics in all animals after a single dose administration.
- Clinical signs:
- other: Detailed clinical findings of the study are presented in Table 2 (below).
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
Table 2. Clinical signs - individual data.
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | Timepoint | Observations |
1 | 1 / Female | 2000 | 0 - 60 min | nsf |
60 - 120 min | Moderately reduced spontaneous activity, slight piloerection, hunched posture | |||
120 - 180 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, slight ataxia, slow movements | |||
180 - 240 min | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, slight ataxia | |||
240 min - d 2 | Slightly reduced spontaneous activity, hunched posture, slight piloerection | |||
d 2 - 15 | nsf | |||
2 / Female | 2000 | 0 - 60 min | nsf | |
60 - 120 min | Moderately reduced spontaneous activity, slight ataxia, slight piloerection, hunched posture | |||
120 - 180 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, slight ataxia, slow movements | |||
180 - 240 min | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, slight ataxia | |||
240 min - d 2 | Slightly reduced spontaneous activity, hunched posture, slight piloerection | |||
d 2 - 15 | nsf | |||
3 / Female | 2000 | 0 - 60 min | nsf | |
60 - 120 min | Moderately reduced spontaneous activity, slight ataxia, slight piloerection, hunched posture | |||
120 - 180 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, slight ataxia, slow movements | |||
180 - 240 min | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, slight ataxia | |||
240 min - d 2 | Slightly reduced spontaneous activity, hunched posture, slight piloerection | |||
d 2 - 15 | nsf | |||
2 | 4 / Female | 2000 | 0 - 30 min | nsf |
30 - 60 min | Slightly reduced spontaneous activity, slight piloerection | |||
60 - 120 min | Slightly reduced spontaneous activity, hunched posture, slight piloerection | |||
120 – 180 min | Moderately reduced spontaneous activity, slight ataxia, moderate piloerection, half eyelid-closure, severe diarrhoea, hunched posture, sunken flunks | |||
180 min - d 2 | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, moderate diarrhoea, slight ataxia, sunken flunks | |||
d 2 | Found dead | |||
5 / Female | 2000 | 0 - 30 min | nsf | |
30 - 60 min | Slightly reduced spontaneous activity, slight piloerection | |||
60 - 120 min | Slightly reduced spontaneous activity, hunched posture, slight piloerection | |||
120 - 180 min | Slightly reduced spontaneous activity, slight piloerection, slight diarrhoea, hunched posture | |||
180 - 240 min | Slightly reduced spontaneous activity, hunched posture, slight piloerection, half eyelid-closure, slight diarrhoea | |||
240 min - d 2 | Slightly reduced spontaneous activity, hunched posture, slight piloerection, slight diarrhoea | |||
d 2 -3 | Slightly reduced spontaneous activity, moderate piloerection | |||
d 3 - 4 | Slight piloerection | |||
d 4 - 15 | nsf | |||
6 / Female | 2000 | 0 - 30 min | nsf | |
30 - 60 min | Slightly reduced spontaneous activity, slight piloerection | |||
60 - 120 min | Slightly reduced spontaneous activity, hunched posture, slight piloerection | |||
120 - 180 min | Slightly reduced spontaneous activity, slight piloerection, slight diarrhoea, hunched posture | |||
180 - 240 min | Slightly reduced spontaneous activity, hunched posture, slight piloerection, half eyelid-closure, slight diarrhoea | |||
240 min - d 2 | Slightly reduced spontaneous activity, hunched posture, slight piloerection, slight diarrhoea | |||
d 2 -3 | Slightly reduced spontaneous activity, moderate piloerection | |||
d 3 - 4 | Slight piloerection | |||
d 4 - 15 | nsf |
d = day (day 1 = day of administration); min = minute(s); nsf = no specific findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item 'Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl)-a-L-mannopyranosil-1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-a-L-mannopyranosyl)oxy]decanoate' to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity in all animals and mortality in 1 of 6 animals.
The median lethal dose of 'Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl)-a-Lmannopyranosil-1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-a-Lmannopyranosyl)oxy]decanoate' after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 2500 mg/ kg bw - Executive summary:
The acute oral toxicity of the test item 'Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl)-a-L-mannopyranosil-1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-a-L-mannopyranosyl)oxy]decanoate' in rats after oral administration via gavage was studied according to OECD TG 423.
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended with the vehicle aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg. All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
One animal of the second group treated with the test item at a dose of 2000 mg/kg died spontaneously the day after treatment. All remaining animals survived until the end of the study while temporarily showing signs of toxicity. The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid-closure, ataxia, slow movements, sunken flunks, hunched posture and diarrhoea. All symptoms recovered within up to 4 days postdose. Throughout the 14-day observation period, the weight gain of the surviving animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any animal of any step.
Therefore, a LD50 cut-off value of 2500 mg/kg bw can be derived from this study.
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