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EC number: 600-872-8 | CAS number: 108419-35-8
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 September 1983 - 11 October 1093
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
- EC Number:
- 283-740-9
- EC Name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
- Cas Number:
- 84712-50-5
- Molecular formula:
- C15H30O2
- IUPAC Name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS:
SPECIFIC GRAVITY: 0.874 (SUPPLIED BY SPONSOR)
Test animals
- Species:
- rat
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchland Inc., PA
- Age at study initiation: Approx 16 weeks
- Weight at study initiation: 2.46 to 3,04 Kg
- Housing: Individual suspended stainless steel cage
- Diet: Purina rabbit chow HF (pellets)(ad libitum)
- Water: Automatic watering system (ad libitum)
- Acclimation period: Approx 36 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22 °C
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12 hours light/dark
IN-LIFE DATES: FROM: OCTOBER 11, 1983 TO: OCTOBER 25, 1983
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The dorsal surface from the shoulder region to the lumbar region
- Type of wrap if used: Gauze patch was secured to the trunk of the animal with tape and a plastic sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed, where possible, using water without altering existing response or the integrity of the epidermis
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3,160 mg/kg - Duration of exposure:
- 24 hours
- Doses:
- 3160 mg/kg
- No. of animals per sex per dose:
- 3 males/females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made for the nature, onset, and duration of toxicological signs 2 and 4 hours after dosing and once per day thereafter, for a total of 14 days. Body weights were recorded on the day of dosing (day 0), on day 7 and day 14
- Necropsy of survivors performed: yes. After the day 14 weighings and observations, all rabbits were euthanized intravenous administration of sodium pentobarbital. Postmortem gross examinations were performed on all animals by qualified personnel. - Statistics:
- The means and standard deviations of the body weights were calculated
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 160 mg/kg bw
- Mortality:
- All animals survived until termination of the study.
- Clinical signs:
- other: Erythema, ranging from very slight to severe, was noted in all animals at 24 hours and on day 3. By day 7, very slight to well-defined erythema was observed in 5 animals and persisted in 4 animals at study termination. Very slight edema was noted in 4 ani
- Gross pathology:
- Postmortem gross examination revealed 1 animal with liver and salivary gland discoloration; 1 animal with discolored kidneys, enlarged spleen and hair ball in stomach; and 1 animal with alopecia in the abdominal area and slight brown staining of the ano-genital area. Three of the 6 test animals exhibited no observable abnormalities.
- Other findings:
- - Other observations: Two animals were noted with their collars off and one animal with collar in its mouth. This did not impact the outcome of this study.
Any other information on results incl. tables
Results tables can be found in the attachment to this RSS.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50> 3160 mg/kg
- Executive summary:
The acute dermal systemic toxicity of the test substance was evaluated in rabbits following topical occlusive exposure. Test material was applied as a single dose of 3160 mg/kg to the clipped backs of 3 male and 3 female rabbits. The test material remained in contact with the intact skin of all animals for a period of 24 hours. The amount of material remaining on the skin of each animal after the 24 hour exposure was estimated.
Observations were made as to the nature, onset, severity, and duration of toxicological signs 2 and 4 hours after dosing and once per day thereafter, for a total of 14 days. Dermal responses were evaluated 24 hours after topical application and on days 3, 7, 10 and 14 according to the draize method of scoring. Body weights were recorded on the day of dosing (day 0), day 7 and day 14. After the day 14 weighings and observations, all surviving rabbits were euthanized by intravenous administration of sodium pentobarbital, necropsies were performed on all animals by qualified personnel.
There were no animal deaths noted during the course gf the study. As compared to starting body weights 5 of the 6 rabbits exhibited slight body weight decreases at day 7; with only 2 animals having decreased body weights at 14 days.
Erythema was noted in all study animals and edema was noted in 4 of the 6 animals during the course of the study. Erythema scores ranged from slight i'o severe, and edema ranged from very slight to slight. All animals exhibited desquamation and 2 animals had eschar during the course of the study. Slight dermal irritation study, persisted in 4 of the test animals through termination of study.
Clinical in-life observations included 2 animals with food consumption decrease (day 7 only), 1 animal with unthrifty coat and ano-genital staining and 1 animal with alopecia.
Postmortem gross examination revealed liver and salivary gland discoloration in 1 animal; kidney discoloration and spleen enlargement in 1 animal and alopecia in 1 animal. Three of the 6 test animals exhibited no observable abnormalities.
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