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EC number: 305-769-9 | CAS number: 95009-41-9
- 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
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study, tested with the source substance Decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS No. 68583-51-7). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Züchter Winkelmann, Borchen, Germany
- Age at study initiation: approx. 4 weeks
- Weight at study initiation: 46 - 58 g (males), 46 - 57 g (females)
- Housing: 2-3 animals of the same sex per cage in Makrolon-cages Typ M 5 (EBECO, Castrop-Rauxel, Germany)
- Diet: pelleted Haltungsdiät Altromin 1324 DK (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 38-70
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Dosing solutions were prepared daily immediately before dosing by dissolving appropriate amounts of the test material in peanut oil yielding a final concentration of 20%.
VEHICLE
- Justification for use and choice of vehicle (if other than water): solubility of test substance
- Concentration in vehicle: 2.0, 6.0 and 20.0% (w/v)
- Amount of vehicle (if gavage): 5 mL/kg bw/day - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- once daily, 5 days/week
- Remarks:
- Doses / Concentrations:
100, 300 and 1000 mg/kg bw/day
Basis:
actual ingested - No. of animals per sex per dose:
- 10 (main study)
5 (satellite control and high dose group) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: achievement of a high security margin, identification of the not cumulative toxic dose and the identification of the reversibility of a possible cumulative toxic effect.
- Rationale for selecting satellite groups: high dose and control groups to identify a possible reversiblity of the effects
- Post-exposure recovery period in satellite groups: 34 days - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily during acclimation period, twice daily during application period and daily on weekends and holidays.
- Cage side observations checked: mortality, intoxication symptoms
BODY WEIGHT: Yes
- Time schedule for examinations: at study initiation, once during acclimatisation period, daily during the application period.
FOOD CONSUMPTION: Yes
- Time schedule for examinations: weekly.
WATER CONSUMPTION: Yes
- Time schedule for examinations: weekly.
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: day before sacrifice.
- Dose groups that were examined: high dose and control satellite groups.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 6 weeks after application and at study termination.
- How many animals: all test animals
- Parameters checked: erythrocyte count, hematocrit, mean cell volume, hemoglobin, leucocyte count, thrombocyte count, differential blood count.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 6 weeks after application and at study termination.
- How many animals: all test animals
- Parameters checked: gamma glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatise, sodium, potassium, glucose, urea, protein, calcium, creatinine, cholesterol, chloride, bilirubin.
OTHER: organ weights: absolute and relative organ weights of brain, testes, heart, liver, spleen, adrenal gland, kidney, thymus. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, whole body, especially eyes, skin, abdomen, chest and skull.
HISTOPATHOLOGY: Yes, aorta thoracica, eye, colon, proventriculus, small intestine, cerebrum, urinary bladder, skin, heart, testes, hypophysis, cerebellum, liver, lung, trachea, axillary lymphnodes, mesentery lymphnodes, spleen, epididymis, adrenal gland, peripheral nerve, kidney, ovary, pancreas, prostate, vesicula seminalis, thyroid gland, salivary gland, esophagus, skeletal muscles, thymus, uterus, tongue, rumen. - Statistics:
- - t-test according to Sachs to evaluate significant differences in body weight.
- t-test according to Dunnett to evaluate significant differences in clinical chemistry and haematology.
- steel test to evaluate significant differences in organ weight. - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 100 mg/kg bw/day: 1 female died; 300 mg/kg bw/day: 1 male and 1 female died; 1000 mg/kg bw/day: 1 female and 1 male died, non-adverse
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 100 mg/kg bw/day: 1 female died; 300 mg/kg bw/day: 1 male and 1 female died; 1000 mg/kg bw/day: 1 female and 1 male died, non-adverse
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- no adverse effects
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
100 mg/kg bw/day: 1 female died at the last investigation and blood collection; 300 mg/kg bw/day: 1 male died in week 7 at the intermediate investigation and blood collection and 1 female died at the last investigation and blood collection; 1000 mg/kg bw/day: 1 female and 1 male died both at the last investigation and blood collection. No substance-related lethality was observed.
BODY WEIGHT AND WEIGHT GAIN
Normal weight gain was observed in all test groups and comparable to the body weight gain in the control groups.
FOOD CONSUMPTION
1000 mg/kg bw/day (males, additional group): higher food consumption due to higher body weight at start of the study; 1000 mg/kg bw/day (females): increase in food consumption in week 10, 12 and 13 due to one individually caged animal. 100, 300 and 1000 mg/kg bw/day (females): a not concentration dependent decrease in food consumption was observed in the mean of the test animals (none adverse).
WATER CONSUMPTION
The water consumption of the male test groups showed not dose-related variations. The water consumption of the female test groups showed a not dose-related reduction. Furthermore, an increase in the female high dose group in week 10, 12 and 13 was observed due to the increased food consumption. Water consumption in the additional female high dose group was comparable to the control group. The mean water conversion for male and female test animals during week 1-6 and 8-13 showed no substance-related differences.
OPHTHALMOSCOPIC EXAMINATION
No treatment related findings. Single spontaneous findings were observed e.g. periorbital edema due to the blood collection. In the mandibular lymph nodes infrequent findings of ink pigments, originated from the earmarks.
HAEMATOLOGY
The mean values of all tested parameters of the intermediate and final examination showed no differences in comparison to the control values.
CLINICAL CHEMISTRY
The mean values of all tested parameters of the intermediate and final examination showed no differences in comparison to the control values.
ORGAN WEIGHTS
In females in the 100 mg/kg bw/day group the relative organ weights of the kidneys and the brain were slightly increased. This difference in organ weights revealed no correlation to further parameters and was therefore evaluated as random.
GROSS PATHOLOGY
No treatment related findings. Single spontaneous findings were found in all groups e.g. hydrometra and edema formation in the area of the salivary gland. In the additional male high dose group one animal showed high grade urinary stone formation in the bladder.
HISTOPATHOLOGY: NON-NEOPLASTIC
No treatment related findings. Single spontaneous findings were observed in all investigated animals e.g. interstitial infiltrates in the lung, calcareous deposits, hydronephrosis, cystitis, hydrometra and mammary hyperplasia.
OTHER FINDINGS
1000 mg/kg bw/day: one animal was caged individually due to aggressive behaviour until week 6 of the study period. In one male a temporary prominent eye ball was observed after the last blood taking.
300 mg/kg bw/day: one male animal showed a swelling of the right ear. - Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Critical effects observed:
- not specified
Reference
Table 1. Body weight gain.
body weight gain [g] |
males females dose [mg/kg bw/day] |
|||||||
0 |
100 |
300 |
1000 |
0 |
100 |
300 |
1000 |
|
week 1-7 |
167 |
168 |
181 |
169 |
90 |
79 |
78 |
80 |
week 7-14 |
80 |
82 |
86 |
88 |
37 |
35 |
33 |
34 |
week 1-14 |
247 |
250 |
267 |
257 |
127 |
114 |
111 |
114 |
Table 2. Food and water consumption.
|
males females dose [mg/kg bw/day] |
|||||||
|
0 |
100 |
300 |
1000 |
0 |
100 |
300 |
1000 |
Food consumption |
144 |
145 |
154 |
149 |
117 |
108 |
106 |
114 |
Water consumption |
246 |
240 |
252 |
243 |
194 |
174 |
174 |
182 |
Table 3. Kidney and brain weights.
|
males females dose [mg/kg bw/day] |
|||||||
0 |
100 |
300 |
1000 |
0 |
100 |
300 |
1000 |
|
Kidney weight (absolute) [g] after 13 weeks treatment |
2.12 |
2.04 |
2.3 |
2.22 |
1.36 |
1.37 |
1.31 |
1.28 |
Brain weight (absolute) [g] after 13 weeks treatment |
2.02 |
1.99 |
2.05 |
2.01 |
1.81 |
1.88 |
1.85 |
1.83 |
Kidney weight (relative) [g] expressed as a percentage of body weights |
0.6 |
0.58 |
0.61 |
0.61 |
0.6 |
0.64* |
0.61 |
0.6 |
Brain weight (relative) [g] expressed as a percentage of body weights |
0.57 |
0.57 |
0.55 |
0.56 |
0.8 |
0.88** |
0.87 |
0.86 |
*:Level of significane 99% in comparison with control value.
**: Level of significane 95% in comparison with control value
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2 due to read-across) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s) and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, in accordance with AnnexXI, 1.5, of Regulation (EC) No 1907/2006.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity
There are no data for repeated dose toxicity available for Fatty acids, vegetable-oil, esters with dipropylene glycol. In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5 read-across from an appropriate substance is conducted to fulfill the standard information requirements set out in Regulation (EC) No 1907/2006, Annex VIII, 8.5.
According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.
Fatty acids, vegetable-oil, esters with dipropylene glycol is a UVCB substance comprised of diesters based on 1,2-dipropylene glycol bonded to octanoic and decanoic acid (C8 – C10). Based on structural similarities and common functional groups, read-across to Decanoic acids, mixed diesters with octanoic acid and propylene glycol is justified (CAS 68583 -51 -7). For further details on the read-across approach, please refer to the analogue justification in section 13 of the technical dossier.
CAS 68583-51-7
Decanoic acid, mixed diesters with octanoic acid and propylene glycol was tested for subchronic oral toxicity in a 90-day study according to OECD guideline 408 in compliance with GLP (Pittermann, 1993).
Groups of 10 Wistar rats per sex and dose were given 100, 300 and 1000 mg/kg bw/day of the test material in peanut oil by gavage, 5 days/week for 13 weeks. A concurrent negative control group receiving the vehicle only was included. Furthermore, additional satellite control and high-dose groups with 5 animals per sex were included in the study for investigating the reversibility of possible effects after a 34-day post-exposure recovery period. No clinical signs or mortality occurred in relation to the test substance during the study period in any animal. During the study period, 5 animals out of different groups died at blood collection time points (no further information). No adverse effects on body weight or body weight gain were noted. Higher food consumption in the additional male high-dose group was observed due to higher body weight at start of the study. An increase in food consumption in the female high-dose group in Week 10, 12 and 13 was observed due to one animal caged individually. The water consumption of the male and female test groups showed no dose-related variations or reductions. Ophthalmoscopic examinations revealed no treatment related findings. No treatment-related changes in the haematological and clinical parameters and organs weights were measured. During gross pathology and histopathology no treatment-related findings were observed. Furthermore, the animals of the recovery groups showed no macroscopical compound-related alterations in the observed organs.
Based on the lack of adverse effects, a NOAEL of 1000 mg/kg bw/day (m, f) was identified in this study.
Conclusion for subchronic repeated dose toxicity, oral
In summary, subchronic oral administration of Decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) showed no adverse systemic effects resulting in a NOAELs of 1000 mg/kg bw/day. Based on read across,Fatty acids, vegetable-oil, esters with dipropylene glycol is not considered as hazardous after subchronic exposure.
There are no data available on the repeated dose toxicity after dermal application and inhalation.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Hazard assessment is conducted by means of a read-across from a structural analogue substance. The available study is adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).
Justification for classification or non-classification
The available data on repeated dose toxicity of the structural analogue does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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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