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EC number: 946-882-9 | CAS number: -
- 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
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:
- July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- single dose level of 5000 mg/kg
- No. of animals per sex per dose:
- 3 female
- Control animals:
- no
- Details on study design:
- Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were similarly dosed. The rats were observed at 15 min, 1, 2 and 4 h post-dose, then once daily for 14 d for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Bodyweights were recorded pre-test, weekly and at termination. All animals were observed for gross pathology.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: one animal briefly had dhiarrea on Day 0
- Gross pathology:
- none
- Other findings:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the acute oral LD50 in female rats was > 5000 mg/kg bw.
- Executive summary:
A study was conducted to evaluate the acute oral toxicity of the test substance according to OECD Guideline 425, in compliance with GLP. Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were similarly dosed. The rats were observed at 15 min, 1, 2 and 4 h post-dose, then once daily for 14 d for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Bodyweights were recorded pre-test, weekly and at termination. All animals were observed for gross pathology. All animals survived to study end. One animal briefly had diarrhoea on Day 0; there were no additional abnormal physical signs observed. Two animals gained weight and one animal lost weight between Days 7 and 14. The gross necropsy of all animals revealed no observable abnormalities. Under the study conditions, the acute oral LD50 in female rats was > 5000 mg/kg bw (Unnamed, 2012).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Adequate quality
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 22 Mar - 05 Apr 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Limited information on test substance and animal husbandry. Read across study.
- Justification for type of information:
- Based on its composition and physico chemical properties, fatty acids, C5-10, esters with pentaerythritol is considered to be a suitable read across substance to address the acute inhalation toxicity endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- (No details on test material and limited data on animal husbandry)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Alpk:APfSD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Alderly Park, Cheshire, UK
- Age at study initiation: approx. 7 weeks - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: dried and filtered air
- System of generating aerosols: glass concentric jet atomiser
- Method of particle size determination: Marple Cascade Impactor
- Temperature, humidity, pressure in air chamber: 20 L/min
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrically
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.51 µm/2.51 - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- particulate concentrations of the test atmospheres close to the animals breathing zone were measured gravimetrically
- Duration of exposure:
- 4 h
- Concentrations:
- 5.0 mg/L (nominal)
5.10 mg/L (analytical) - No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for gross clinical abnormalities during exposure and were checked daily thereafter. A detailed examination was conducted after exposure on day 1 and on consecutive days, up to and including day 15. Individual body weights were recorded on Day 1 and Days 2, 3, 8 and day 15.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.1 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Some clinical signs were noticed, which consisted of hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for
- Body weight:
- No effect on body weight was noted.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.1 mg/L air.
- Executive summary:
A study was conducted to evaluate the acute inhalation toxicity of the read across substance, fatty acids, C5-10, esters with pentaerythritol, according to a method equivalent or similar to OECD Guideline 403. Five rats per sex were exposed (nose only) to an aerosol of the test material with an analytical concentration of 5.10 mg/L air (nominal concentration was 5.0 mg/L) for an exposure duration of 4 h. No mortality occurred during the 14 day study period. Some clinical signs were noticed, which consisted of hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for exposure. No effect on bodyweight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.1 mg/L air (Parr-Dobrzanski, 1994).
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 22 Mar - 05 Apr 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Limited data on test substance. Read across study.
- Justification for type of information:
- Based on its composition and physico chemical properties, fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol is considered to be a suitable read across substance to address the acute inhalation toxicity endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Limited data on study substance
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Alpk:APfSD
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- not specified
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Not stated
- Source and rate of air: 20 L/min using a peristaltic pump
- Method of conditioning air: Clean dry air (dried and filtered, no further details)
- System of generating particulates/aerosols: Glass concentric jet atomiser
- Method of particle size determination: Marple Cascade Impactor
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetrical measurement
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: No Data
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.76 µm / 2.35 µm - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetrically measurement of particulate concentrations
- Duration of exposure:
- 4 h
- Concentrations:
- 5 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: on Days 1, 2, 3, 8 and 15
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Clinical signs seen during and/or immediately after exposure were hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur. In general, animals showed a rapid recovery from these effects by Day 2, although, hunched posture and
- Body weight:
- No effect on body weight was noted.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.0 mg/L air.
- Executive summary:
A study was conducted to evaluate the acute inhalation toxicity of the read across substance, fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol, according to a method equivalent or similar to OECD Guideline 403. Five rats per sex were exposed (nose only) for 4 h to an aerosol of the test substance with an analytical concentration of 5.0 mg/L air. No mortality occurred during the 14 d study period. Clinical signs were seen during and/or immediately after exposure were hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur. In general, animals showed a rapid recovery from these effects by Day 2, although hunched posture and piloerection persisted in a few animals to Days 4 and 8, respectively. No effect on bodyweight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.0 mg/L air (Parr-Dobrzanski, 1994).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 0.005 mg/m³ air
- Quality of whole database:
- Adequate quality
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 05 Jan - 19 Jan 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Limited data on test substance. Read across study.
- Justification for type of information:
- Based on its composition and physico chemical properties, 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid is considered to be a suitable read across substance to address the acute dermal toxicity endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- limited data on test substance
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- limited data on test substance
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males: 202 - 217 g (male) and 202 - 212 g (female)
- Housing: individually housed in suspended polypropylene cages for the time of exposure and in groups of five, by sex, for the reminder of the study.
- Diet: ad libitum, Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, UK
- Water: ad libitum
- Acclimation period: minimum 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 (18 at one ocasion, this was not considered relevant for the study)
- Humidity (%): 47-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approx. 10% of total body surface
- Type of wrap if used: gauze secured with self adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with cotton wool moistened with distilled water
- Time after start of exposure: 24 h - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5 h; 1 h; 2 h and 4 h after dosing and daily thereafter for 14 days. Weighing on Days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Skin reactions according to Draize Scoring System (1977) - Statistics:
- Not required
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the acute dermal LD50 in male and female rats was> 2000 mg/kg bw.
- Executive summary:
A study was conducted to evaluate the acute inhalation toxicity of the read across substance, 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid, according to OECD Guideline 402, in compliance with GLP. The back and flanks regions of five male and female Sprague Dawley rats was treated with 2000 mg/kg bw under semiocclusive conditions. Twenty four hours after dosing, the treated area of skin was cleaned with distilled water and cotton wool. No mortality occurred and no clinical signs of toxicity were observed in any of the animals during the 14 d observation period. The test substance had no effect on bodyweight. Necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute dermal LD50 in male and female rats was> 2000 mg/kg bw (Allen, 1999).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Adequate quality
Additional information
Oral
A study was conducted to evaluate the acute oral toxicity of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to OECD Guideline 425, in compliance with GLP. Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were similarly dosed. The rats were observed at 15 min, 1, 2 and 4 h post-dose, then once daily for 14 d for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Bodyweights were recorded pre-test, weekly and at termination. All animals were observed for gross pathology. All animals survived to study end. One animal briefly had diarrhoea on Day 0; there were no additional abnormal physical signs observed. Two animals gained weight and one animal lost weight between Days 7 and 14. The gross necropsy of all animals revealed no observable abnormalities. Under the study conditions, the acute oral LD50 in rats was > 5000 mg/kg bw (Unnamed, 2012).
Inhalation
Study 1:
A study was conducted to evaluate the acute inhalation toxicity of the read across substance, fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol, according to a method equivalent or similar to OECD Guideline 403. Five rats per sex were exposed (nose only) for 4 h to an aerosol of the test substance with an analytical concentration of 5.0 mg/L air. No mortality occurred during the 14 d study period. Clinical signs were seen during and/or immediately after exposure were hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur. In general, animals showed a rapid recovery from these effects by Day 2, although hunched posture and piloerection persisted in a few animals to Days 4 and 8, respectively. No effect on bodyweight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.0 mg/L air (Parr-Dobrzanski, 1994).
Study 2:
A study was conducted to evaluate the acute inhalation toxicity of the read across substance, fatty acids, C5-10, esters with pentaerythritol, according to a method equivalent or similar to OECD Guideline 403. Five rats per sex were exposed (nose only) to an aerosol of the test material with an analytical concentration of 5.10 mg/L air (nominal concentration was 5.0 mg/L) for an exposure duration of 4 h. No mortality occurred during the 14 day study period. Some clinical signs were noticed, which consisted of hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for exposure. No effect on bodyweight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute inhalation LC50 in male and female rats was > 5.1 mg/L air (Parr-Dobrzanski, 1994).
Dermal
A study was conducted to evaluate the acute inhalation toxicity of the read across substance, 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid, according to OECD Guideline 402, in compliance with GLP. The back and flanks regions of five male and female Sprague Dawley rats was treated with 2000 mg/kg bw under semiocclusive conditions. Twenty four hours after dosing, the treated area of skin was cleaned with distilled water and cotton wool. No mortality occurred and no clinical signs of toxicity were observed in any of the animals during the 14 d observation period. The test substance had no effect on bodyweight. Necropsy and histopathological examination revealed no substance-related findings. Under the study conditions, the acute dermal LD50 in male and female rats was> 2000 mg/kg bw (Allen, 1999).
Justification for classification or non-classification
Based on the results of studies with appropriate read across substances, the test substance does not require classification for acute toxicity according to EU CLP (EC 1272/2008) criteria.
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