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EC number: 246-885-9 | CAS number: 25354-97-6
- 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
In a study performed with the target substance 2 -hexyldecanoic acid the oral LD50 was > 2020 mg/kg.
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:
- November - December 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 2/24/81
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- EPA 540/9-84-014, November 1984
- Deviations:
- no
- GLP compliance:
- yes
- 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: Harlan Sprague Dawley, Inc., Houston, Texas, USA
- Age at study initiation: young adults
- Weight at study initiation: 237 - 253 g (males), 177 - 184 g (females)
- Fasting period before study: 16 hours
- Housing: 1 animal per cage in suspended, wire-bottomed, stainless steel cages with paper and aspen bedding, changed three times/week
- Diet: Purina Formulab Chow #5008 ad libitum, no comtaminants were expected to have been present in the feed which would have interfered with or affected the results of the study
- Water: municipal water supply ad libitum from automatic water system, no comtaminants were expected to have been present in the water which would have interfered with or affected the results of the study
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72 ± 5
- Humidity (%): 30 - 80
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 1995-12-06 To: 1995-12-20 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.34 mL/kg body weight
Individual doses were calculated for each animal on its fasted body weight, each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle
- Doses:
- 2020 mg/kg
- 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 and weighing: Observation for mortality and clinical/behavioral signs of toxicity were made three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Body weights were recorded just prior to dosing and on days 7 and 14. - Statistics:
- not performed
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 020 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occurred
- Clinical signs:
- other: Clinical signs included crust around nose, diarrhea, nasal discharge, piloerection, polyuria, ptosis, respiratory gurgle, salivation and staining of muzzle. Animals were asymptomatic by Day 6 of the study.
- Gross pathology:
- The gross necropsy conducted at termination of the study revealed no observable abnormalities.
- Other findings:
- none
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral LD50 was determined to be greater than 2020 mg/kg bw in albino rats.
- Executive summary:
The test material was evaluated for its acute oral toxicity potential in albino rats when administered as a single gavage dose at a level of 2020 mg/kg to males and females. No mortality occurred during the study. Clinical signs included crust around nose, diarrhea, nasal discharge, piloerection, polyuria, ptosis, respiratory gurgle, salivation and staining of muzzle. Animals were asymptomatic by Day 6. There was no effect on body weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was determined to be greater than 2020 mg/kg.
Reference
Table: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]
Dose |
Mortality (# dead/total) |
Time range of deaths (hours) |
Number with evident toxicity(#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2020 |
0/5 |
0/5 |
0/10 |
- |
5/5 |
5/5 |
10/10 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 020 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
acute oral toxicity:
The target substance 2 -hexyldecanoic acid was evaluated for its acute oral toxicity potential in albino rats when administered as a single gavage dose at a level of 2020 mg/kg to males and females. No mortality occurred during the study. Clinical signs included crust around nose, diarrhea, nasal discharge, piloerection, polyuria, ptosis, respiratory gurgle, salivation and staining of muzzle. Animals were asymptomatic by Day 6. There was no effect on body weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was determined to be greater than 2020 mg/kg.
In a supporting study with the source substance 2-butyloctanoic acid, 6 Sprague-Dawley rats (3 male and 3 female) were treated with 2000 mg/kg bw test substance by oral gavage according to OECD guideline 423 in compliance with GLP. No animal died during the study, the clinical findings noted were piloerection, hunched posture, salivation, reduced activity, swollen abdomen, difficulty in moving, hairloss on head and red staining on muzzle. Recovery of clinical signs had occurred by day 2 in females and by day 13 in males. The lack of mortality demonstrates the LD50 to be in excess of 2000 mg/kg body weight.
In the supporting study, performed with the Source substance Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid according to OECD guideline 423 in compliance with GLP, 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. All animals survived until the end of the study with showing slight signs of toxicity on the day of treatment. 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 and piloerection. All animals were completely recovered after 240 min. Result: LD50: > 2000 mg/kg bw.
Under the conditions of another supporting study, a single oral application of the similar substance 2-decyltetradecanoic acid to rats at a dose 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of 2 -decyltetradecanoic acid after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): >5000 mg/ kg body weight.
acute toxicity: inhalation
waiving: The target substance has very low vapor pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.
acute toxicity: dermal
waiving: The substance does not meet the criteria for classification for acute oral toxicity and STOT.
Supporting: Single dermal application of the source substance Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid to rats, at a dose of 2000 mg/kg body weight was associated with no mortality and no signs of toxicity but slight signs of irritation. The dermal LD50 was determined to be > 2000 mg/kg.
Justification for classification or non-classification
2 Hexyldecanoic acid on the available acute toxicity information does not present an acute toxicity hazard and does not require classification according Regulation (EC) No 1272/2008.
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