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EC number: 701-068-0 | CAS number: 2156592-58-2
- 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
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Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD-Guideline dose-range finding study but of reliable qualitiy and conducted according to GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA TSC Health Effects Test Guideline (OTS 1983)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Pesticide Assessment Guidelines-Subdivision F-Hazard Evaluation, 1982
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- (Z)-octadec-9-enylamine
- EC Number:
- 204-015-5
- EC Name:
- (Z)-octadec-9-enylamine
- Cas Number:
- 112-90-3
- Molecular formula:
- CH3(CH2)7CH=CH(CH2)7CH2NH2
- IUPAC Name:
- octadec-9-en-1-amine
- Reference substance name:
- Oleyl Alkylamines
- IUPAC Name:
- Oleyl Alkylamines
- Details on test material:
- - Name of test material (as cited in study report): (Z)-9-octadecenylamine
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in-house breeding station at Intox
- Age at study initiation: young adults
- Weight at study initiation: 206 - 321 g
- Fasting period before study: no
- Housing: stainless-steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approx 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 °C
- Humidity (%): 40 - 56
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 hours periodically
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: mineral oil
- Details on exposure:
- TEST SITE
- Area of exposure: 10 %
- % coverage: 100
- Type of wrap if used: porous gauze covered with Vetwrap elastic bandage
- Time intervals for shavings or clipplings: 7 days
REMOVAL OF TEST SUBSTANCE
- Washing (if done): daily
- Time after start of exposure: 6 hours after test article apllication
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL/kg
- Concentration (if solution): 0, 0.3, 1.5 and 3%
- Constant volume or concentration used: yes - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Two 5-days periods with an intermediate 2-day non-dosing period
- Frequency of treatment:
- daily, 5 days per week, 2 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 %
Basis:
nominal per unit area
- Remarks:
- Doses / Concentrations:
0.3 %
Basis:
nominal per unit area
- Remarks:
- Doses / Concentrations:
1.5 %
Basis:
nominal per unit area
- Remarks:
- Doses / Concentrations:
3.0 %
Basis:
nominal per unit area
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on pilot study
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: no satellite groups
- Post-exposure recovery period in satellite groups: n.a.
- Section schedule rationale (if not random): n.a. - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: days 2, 4, 6, 8, 10, 12 and 14 (first dosing day = day 1)
BODY WEIGHT: Yes
- Time schedule for examinations: prior to study initiation, weekly thereafter
FOOD CONSUMPTION:
- Food consumption: determined weekly
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: No data
HISTOPATHOLOGY: No
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- erythema at lowest test concentration; necrosis at mid- and high dose
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- weight loss in females of highest dose during first week
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- 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:
- not specified
- Histopathological findings: non-neoplastic:
- not examined
Effect levels
- Dose descriptor:
- LOAEL
- Remarks:
- local dermal effects
- Effect level:
- 0.3 other: %
- Sex:
- male/female
- Basis for effect level:
- other: dermal irritation responses
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on mild to moderate dermal irritation observed in all dose groups, a NOAEL for local effects could not be established. Based on the grading of dermal effects, the lowest dosage of 0.3% (v/v) is regarded to be a LOAEL.
- Executive summary:
Octadecenylamine (oleylamine) was dermally applied on two 5-days periods with intermediate 2-day non dosing-period to male and female Sprague-Dawley rats (Intox Laboratories, 1985). Animals of the control groups received the vehicle only (mineral oil).
Based on the results of a pilot study, groups of young adult rats (4 males and 4 females) were treated dermally with the test substance at concentrations of 0, 0.3, 1.5 and 3.0% (v/v) in mineral oil (corresponding to doses of 0, 12.5, 62.5 and 125 mg/kg bw/d). Rats were treated for two five-day dosing periods with an intermediate two-day non-dosing period in order to more closely reproduce conditions of human exposure to the test substance. The first day of dosing was designated as Day 1. Due to excessive tissue destruction indicated by sloughing, scores of moderate to severe erythema, scabbing, hardening of the skin, and sensitivity to touch, the dosing at the intermediate and high dose levels (1.5 and 3.0%) was discontinued on Day 9. These animals were subsequently sacrificed on Day 10. At initiation of dosing the rats’ body weights ranged from 205.7 to 321.3 g. Rats were acclimated to the laboratory for seven days prior to test substance application. Water and food were provided ad libitum. Approximately 24 hours prior to test substance application, the fur was clipped from the dorsal area of each animal. Shaving was repeated one week later. The test substance was applied at a volume dosage of 5 ml/kg. The application site was covered by a porous gauze dressing that was held in place with tape, and covered with a taped elastic bandage. Each day, wrappings were removed approximately six hours after test substance application and the test sites were washed with warm water to remove excess test substance. Observations of signs of toxicity were made once each day. Body weights were recorded during acclimation, weekly during the study and at sacrifice. Food consumption was recorded weekly during the study. Morbidity/mortality checks were examined prior to test substance administration on days 2, 4, 6, 8, 10, 12 and 14 for signs of erythema and necropsies were performed. Animals were killed and discarded three days following the completion of dosing.
All rats survived until scheduled sacrifice. Concentrations of 1.5 and 3.0% produced moderate to severe irritation (erythema scores 2-4), which in some instances progressed to hardening and sloughing of the skin. A number of rats were sensitive to touch. In the 0.3 % group, erythema scores of 1 to 2 were observed, indicating mild to moderate irritation, and flaking of the outer layers of the epidermis was observed. An increased sensitivity in females to the irritant effects of the test substance as compared to males was observed. In the control group, one male showed an erythema score of 1 at one observation. All rats in the 1.5 and 3% groups were sacrificed on day 9 of the study due to the irritant/corrosive effects of the test substance. No other treatment-related irritant effects or clinical signs were observed. A significant treatment-related effect on body weight was observed for males at day 7. Individual group comparisons revealed that body weights in both the 1.5 and 3% groups were significantly lower than controls. Females in the 3.0% group showed a mean weight loss during the first week of the study, although this finding was not significant. Food consumption during the first week of study was reduced significantly in the 1.5% group males when expressed as total food consumed. No significant difference was noted when expressed on a per weight basis. The study provides additional data on the toxicity of repeated dermal dosing, including severe irritation, of this test substance at concentrations of 0.3, 1.5 and 3.0%. A NOAEL for local dermal effects could not be derived, the LOAEL was 0.3% (v/v). No NOAEL for systemic toxicity was derivable because of lack of histomorphology data from other organs and tissues.
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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