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EC number: 270-470-1 | CAS number: 68441-66-7
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity - oral
The oral median lethal dose (LD50) value of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid in Wistar Han rats was established to exceed 2000 mg/kg body weight.
Acute Inhalation:
In accordance with column 2 of Annex VIII, the acute inhalation test (as required in section 8.5.2.) does not need to be performed for the following reasons:1. inhalation is not the most likely route of exposure based on criteria of use. The vapour pressure of the substance is proposed to be low and exposure to aerosols, particles or droplets of an inhalable size is not anticipated during proposed uses.
Acute Dermal:
Acute toxicity by dermal route (required in section 8.5.3.) does not need to be conducted. Additionally, based on physico-chemical, structural and other toxicological properties the substance is not expected to have potential for a significant rate of absorption through the skin. Results of an in vitro assessment demonstrated no irritation and the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route. Dermal toxicity is not proposed.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Feb 2021 to 02 Mar 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- OECD Guideline 423. Acute Oral Toxicity - Acute Toxic Class Method, December 2001.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- EPA Health Effects Test Guideline OPPTS 870.1100. Acute Oral Toxicity in Rodents, December 2002.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- EC No 440/2008 Part B. Acute Oral Toxicity, Acute Toxic Class Method, May 2008.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- No further details specified in the study report.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Rat
Strain: Crl: WI(Han)
Condition: Outbred, SPF-Quality
Source: Charles River Deutschland, Sulzfeld, Germany
Number of Animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
Age at the Initiation of Dosing: Young adult animals (approximately 8-9 weeks old) were selected.
Weight at the Initiation of Dosing: 145 to 173 g.
Animal Identification
At study assignment, each animal was identified using a subcutaneously implanted electronic identification chip.
Environmental Acclimation
The animals were allowed to acclimate to the Test Facility toxicology accommodation for at least 5 days before the commencement of dosing.
Selection, Assignment, Replacement, and Disposition of Animals
Animals were assigned to the study at the discretion of the coordinating biotechnician, with all animals within ± 20% of the sex mean body weights. Animals in poor health or at extremes of body weight range were not assigned to the study.
Before the initiation of dosing, a health inspection was performed and any assigned animal considered unsuitable for use in the study were replaced by alternate animals obtained from the same shipment and maintained under the same environmental conditions.
The disposition of all animals was documented in the study records.
Husbandry
Housing
On arrival and following assignment to the study, animals were group housed (up to 3 animals of the same sex and same dosing group together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) containing sterilized wooden fibers as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles. The rooms in which the animals were kept were documented in the study records.
Animals were separated during designated procedures/activities. Each cage was clearly labeled.
Environmental Conditions
Target temperatures of 18 to 24°C with a relative target humidity of 40 to 70% were maintained. The actual daily mean temperature during the study period was 19 to 21°C with an actual daily mean relative humidity of 39 to 59%. The value that was outside the targeted range occurred for one day and was without a noticeable effect on the clinical condition of the animals or on the outcome of the study. A 12 hour light/12 hour dark cycle was maintained. Ten or greater air changes per hour with 100% fresh air (no air recirculation) were maintained in the animal rooms.
Food
Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures.
The feed was analyzed by the supplier for nutritional components and environmental contaminants. Results of the analysis were provided by the supplier and are on file at the Test Facility.
It is considered that there were no known contaminants in the feed that would interfere with the objectives of the study.
Water
Municipal tap-water was freely available to each animal via water bottles.
Periodic analysis of the water was performed, and results of these analyses are on file at the Test Facility.
It is considered that there were no known contaminants in the water that would interfere with the objectives of the study.
Animal Enrichment
For psychological/environmental enrichment, animals were provided with paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom), except when interrupted by study procedures/activities. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A single dose of test item was administered to the appropriate animals by oral gavage on Day 1, using a syringe with a plastic gavage cannula attached.
The dose volume for each animal was based on the body weight measurement prior to dosing. Dose volume (mL/kg body weight) was calculated as follows: Dose level (g/kg) / spec.gravity or density (g/mL) * purity correction factor.
The dosing formulations were stirred continuously during dose administration.
Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item. Water was available.
The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. The starting dose level should be the one that is likely to produce mortality in at least some of the animals and was selected based on available toxicity data of the test item. Since read-across studies showed that the oral LD50 of this class of substances is greater than 2000 mg/kg, a limit dose of 2000 mg/kg was used. - Doses:
- Single dose
- No. of animals per sex per dose:
- 3 animals/group
- Control animals:
- no
- Details on study design:
- In - Life Procedures, Observations, and Measurements
Mortality/Moribundity Checks
Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed from cage during observation, unless necessary for identification or confirmation of possible findings.
Clinical Observations
Post - Dose Observations
Post-dose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. The observation period was 14 days.
All the animals were examined for reaction to dosing. The onset, intensity and duration of these signs was recorded (if appropriate), particular attention being paid to the animals for the first hour after dosing.
Body Weights
Animals were weighed individually on Day 1 (pre-dose), 8 and 15. A fasted weight was recorded on the day of dosing.
Terminal Procedures
All animals were sacrificed by oxygen/carbon dioxide procedure at the end of the observation period. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded. - Statistics:
- Not specified in the study report.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: other: Erected fur or hunched posture was observed in the animals on Day 1 only.
- Gross pathology:
- No abnormalities were found at macroscopic postmortem examination of the animals.
- Other findings:
- No further findings specified in the study report.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid in Wistar Han rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
Based on these results, Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments). - Executive summary:
The objective of this study was to assess the toxicity of the test item when administered in a single dose to female rats at one or more defined dosages. Furthermore, the results of the study allowed the test item to be ranked according to most classification systems, currently in use. This study should provide a rational basis for risk assessment in man.
The study was carried out in compliance with the guidelines described in:
OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method".
EC No 440/2008, part B: "Acute Oral Toxicity, Acute Toxic Class Method".
EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity".
JMAFF Guidelines (2000), including the most recent revisions.
Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid was administered by oral gavage to two consecutive groups of three female Wistar Han rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred.
Erected fur or hunched posture was observed in the animals on Day 1 only.
The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
No abnormalities were found at macroscopic postmortem examination of the animals.
The oral median lethal dose (LD50) value of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid in Wistar Han rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
Based on these results, Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Reference
Individual Mortality
Sex: Female Day(s): - Relative to Start Date
2000 mg/kg Group 1 |
|
|
|
Day of Death |
Removal date |
Path Removal Reason |
|
1 |
15 |
23-Feb-2021 |
TERM |
2 |
15 |
23-Feb-2021 |
TERM |
3 |
15 |
23-Feb-2021 |
TERM |
2000 mg/kg Group 2 |
|
|
|
Day of Death |
Removal date |
Path Removal Reason |
|
4 |
15 |
02-Mar-2021 |
TERM |
5 |
15 |
02-Mar-2021 |
TERM |
6 |
15 |
02-Mar-2021 |
TERM |
TERM = Terminal Euthanasia
Individual Clinical Observations
Group 1 Sex: Female 2000 mg/kg |
||||||||||||||||||
|
Observation Type: All Types |
Day(s) Relative to Start Date |
||||||||||||||||
|
|
1 0h |
1 2h |
1 4h |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
1 |
Fur, Erected |
- |
X |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2 |
Fur, Erected |
- |
X |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
3 |
Fur, Erected |
- |
X |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Group 2 Sex: Female 2000 mg/kg |
||||||||||||||||||
|
Observation Type: All Types |
Day(s) Relative to Start Date |
||||||||||||||||
|
|
1 0h |
1 2h |
1 4h |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
4 |
Hunched posture |
X |
X |
X |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
5 |
Hunched posture |
X |
X |
X |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
6 |
Hunched posture |
X |
X |
X |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
X = Present
- = Not Present
Individual Body Weights
Sex: Female Bodyweight (g)
2000 mg/kg Group 1 |
Day(s) Relative to Start Date |
||
|
1 |
8 |
15 |
1 |
157 |
183 |
200 |
2 |
150 |
185 |
189 |
3 |
145 |
174 |
188 |
Mean |
150.7 |
180.7 |
192.3 |
SD |
6.0 |
5.9 |
6.7 |
N |
3 |
3 |
3 |
2000 mg/kg Group 2 |
Day(s) Relative to Start Date |
||
|
1 |
8 |
15 |
4 |
173 |
209 |
218 |
5 |
156 |
181 |
185 |
6 |
151 |
181 |
189 |
Mean |
160.0 |
190.3 |
197.3 |
SD |
11.5 |
16.2 |
18.0 |
N |
3 |
3 |
3 |
Individual Macroscopic Pathology
Animal: 1 Group: 1 Sex: Female Dose: 2000 mg/kg Removal Reason: Terminal Euthanasia Study Day (Week) of Death: 15 (3) Gross Status: Complete Gross Pathology Observations: No observations found |
Animal: 2 Group: 1 Sex: Female Dose: 2000 mg/kg Removal Reason: Terminal Euthanasia Study Day (Week) of Death: 15 (3) Gross Status: Complete Gross Pathology Observations: No observations found |
Animal: 3 Group: 1 Sex: Female Dose: 2000 mg/kg Removal Reason: Terminal Euthanasia Study Day (Week) of Death: 15 (3) Gross Status: Complete Gross Pathology Observations: No observations found |
Animal: 4 Group: 2 Sex: Female Dose: 2000 mg/kg Removal Reason: Terminal Euthanasia Study Day (Week) of Death: 15 (3) Gross Status: Complete Gross Pathology Observations: No observations found |
Animal: 5 Group: 2 Sex: Female Dose: 2000 mg/kg Removal Reason: Terminal Euthanasia Study Day (Week) of Death: 15 (3) Gross Status: Complete Gross Pathology Observations: No observations found |
Animal: 6 Group: 2 Sex: Female Dose: 2000 mg/kg Removal Reason: Terminal Euthanasia Study Day (Week) of Death: 15 (3) Gross Status: Complete Gross Pathology Observations: No observations found |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K1-GLP accredited study to recognised Test Guidelines
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity - oral
Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid was administered by oral gavage to two consecutive groups of three female Wistar Han rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred.
Erected fur or hunched posture was observed in the animals on Day 1 only.
The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
No abnormalities were found at macroscopic postmortem examination of the animals.
The oral median lethal dose (LD50) value of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid in Wistar Han rats was established to exceed 2000 mg/kg body weight.
Justification for classification or non-classification
Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Based on the above mentioned result, classification according to the CLP Regulation (EC) 1272/2008 and the Dangerous Substance Directive 67/548/EC is not necessary.
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