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EC number: 203-931-2 | CAS number: 112-05-0
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1 Dec 1980 to 29 Dec 1980
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Does not meet important criteria of today standard methods: Low animal numbers, only one dose tested, treatment period only 14 days, limited parameters examined (no organ weights, no hematology, clinical biochemistry, or urinalysis)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- 14-day repeated dose dermal toxicity study using 5 male and 5 female rabbits at one dose level. A satellite group of 3 animals was allowed to recover for 14 days
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Nonanoic acid
- EC Number:
- 203-931-2
- EC Name:
- Nonanoic acid
- Cas Number:
- 112-05-0
- Molecular formula:
- C9H18O2
- IUPAC Name:
- nonanoic acid
- Details on test material:
- - Name of test material (as cited in study report): C-182 (nonanoic acid),
- purity: > 96% (see attached document)
- Substance type: colourless liquid
- Physical state: liquid
- Lot/batch No.: C-182
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dutchland Laboratory Animals, Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2.1-3.2 kg (males); 2.3-3.2 kg (females)
- Housing: individually
- Diet (ad libitum): Purina rabbit chow
- Water (ad libitum): tap water
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5-21.1
- Humidity (%): monitored daily
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- other: open, animals with collar
- Vehicle:
- other: mineral oil
- Details on exposure:
- TEST SITE
- Area of exposure: dorsal and lateral, about 10% of the total body surface
- % coverage: about 10%
- Type of wrap if used: application sites not covered
- Time intervals for shavings or clipplings: prior to first dose, reclipping as nessesary during the dosing period
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/kg/day (about 2 mL of test substance solution); test solution and vehicle (for controls) were applied directly onto skin and spread evenly over the entire area with a glass rod.
- Concentration (if solution): 25% w/w in mineral oil; to 100 g of test substance, vehicle was added to acchieve a total weight of 400 g. The mixture was stirred slowly to achieve a homogeneous mixture. Fresh mixtures were prepared weekly.
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): suitable solvent
- Amount(s) applied (volume or weight with unit): 2 mL
- Concentration (if solution): 25% w/w test substance in vehicle
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes; Elisabethan collars - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 14 d
- Frequency of treatment:
- 1x/d, 5d/wk, 10x
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500 mg/(kg bw day) as 25 % solution in mineral oil
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): random by random numbers table
- Rationale for selecting satellite groups: 3 animals (from 10 of the dosed group) were selected as satellite animals for the recovery group
- Post-exposure recovery period in satellite groups: 2 weeks
- Section schedule rationale (if not random): no data
-Skin treatment: The skin of half of the animals (3 males, 2 females) was abraded prior to the first, sixth and eighth substance application. If the integrity of the skin was interrupted because of response to test material application, additional abrasions were not made.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: mortality twice daily, cage side observations daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: prior to first dosing and daily thereafter
BODY WEIGHT: Yes
- Time schedule for examinations: prior to first application, weekly thereafter
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- Time schedule: 6 animals after 2 weeks (3 each with abraded and intact skin regardless of sex, end of treatment period), remaining 3 animals after 4 weeks (end of post exposure recovery period).
- Preserved tissues: adrenals (2), brain, eyes, gonads, heart, intestine (colon, duodenum, ileum), kidneys (2), liver (2), lungs (2) lymph nodes (mesenteric), mammary gland, pancreas, pituitary, salivary gland, skeletal muscle, skin (treated, untreated), spinal cord (cervical), spleen, stomach, thyroid, urinary bladder, uterus/prostate, gross lesions tissue masses. Tissues were preserved in 10% neutral buffered formalin.
HISTOPATHOLOGY: Yes
- Tissues: brain, heart, kidneys, liver, lungs, skin treated and untreated. Tissue slides were prepared, stained with hematoxylin and eosin, and examined microscopically
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortality and no overt clinical signs occured.
DERMAL IRRITATION
Most animals showed slight to severe erythema and edema without necrosis or eschar formation during the first week of the study. Necrosis and eschar occured subsequently in all animals during the second week of treatment. Further effects were atonia, desquamation, fissuring and exfoliation. These effects subsided during the recovery period. One animal exhibited hair loss during the recovery period.
BODY WEIGHT AND WEIGHT GAIN
Most animals treated with the test substance exhibited slicht body weight losses (0.1-0.4 kg) after one week and/or two weeks of study. Animals held for the two weeks recovery period gained weight during this interval.
FOOD CONSUMPTION
Several aminals exhibited a decreased food consumption during the second and third week of the study.
GROSS PATHOLOGY
Mostly, morphological abnormalities of the treated skin were observed (see Dermal Irritation). Other gross morphological and microscopic alterations occured sporadically in treated and control animals and do not appear to be related to the exposure. Other changes were too inconclusively to demonstrate the presence or absence of systemic effect of the test substance.
HISTOPATHOLOGY: NON-NEOPLASTIC
Microscopic examination showed epidermal necrosis, epidermal hyperplasia, hyperkeratosis as well as diffuse and perifollicular dermal inflammation at the test sites. The application sites appeared to be healed at the end of the recovery period (re-epitheliazed and continuous, mild to moderate epidermal hyperplasia and hyperkeratosis, normal follicular structure and population). Treatment-related tissue reactions occured in abraded as well as non-abraded sites.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: reduced food consumption and slight weight losses during exposure, no clearly treatment-related systemic effects, local effects: skin irritation and necrosis
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this repeated dermal toxicity study on rabbits the most prominent effect was irritation and necrosis of the skin. The effects subsided in a recovery group of 3 animals within 14 days. Systemic toxic responses were restricted to unspecific effects (reduced food consumption, body weight loss).
- Executive summary:
5 male and female New Zealand rabbits each were exposed dermally to 0 or 500 mg/kg bw of the test item (purity not stated) 5 d/w for 2 weeks. The skin of 50% of the animals (3 males, 2 females) has been abraded. Six animals (three with abraded and three with intact skin) were examined at the end of exposure. 3 of 10 animals were selected as satellite group for a 2 weeks recovery period.
Several aminals exhibited a decreased food consumption during the second and third week of the study.
Most animals exhibited weight loss (0.1 - 0.4 kg) after 1 or/and 2 weeks of the study. Animals regained weight during the recovery period.
Most animals showed slight to severe erythema and edema during the first week of the study. Necrosis and eschar occured subsequently in all animals during the second week of treatment. Further effects were atonia, desquamation, fissuring and exfoliation. Microscopic examination showed epidermal necrosis, epidermal hyperplasia, hyperkeratosis as well as diffuse and perifollicular dermal inflammation at the test sites. The skin application sites appeared to be healed at the end of recovery period. No clearly treatment-related macroscopic or microscopic lesions were observed in other organs.
The LOAEL in this study is 500 mg/kg bw/day, based on body weight reduction and skin damage, a NOAEL was not derived (Bio/dynamics, 1981).
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