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EC number: 679-514-8 | CAS number: 154279-60-4
- 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:
- April 7, 2005 - May 28, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 402 and EPA OPPTS 870.1200 with acceptable restrictions (less than three dose levels were used) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- , less than three dose levels were used
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- , less than three dose levels were used
- GLP compliance:
- yes
- Test type:
- other: Acute dermal toxicity study with two dose levels.
- Limit test:
- no
Test material
- Reference substance name:
- N-(butan-2-yl)-4-({4-[(butan-2-yl)amino]cyclohexyl}methyl)cyclohexan-1-amine
- EC Number:
- 679-514-8
- Cas Number:
- 154279-60-4
- Molecular formula:
- C21H42N2
- IUPAC Name:
- N-(butan-2-yl)-4-({4-[(butan-2-yl)amino]cyclohexyl}methyl)cyclohexan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): Clearlink 1000
- Physical state: Clear colorless to pale yellow liquid.
- Batch No.: CL-29720041
- Storage condition of test material: Room temperature.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Texas Animal Specialities, Humble, TX.
- Age at study initiation: 8 weeks.
- Weight at study initiation: 255-306 g (males) and 176-200 g (females)
- Fasting period before study: No
- Housing: Suspended, wire bottom, stainless steel cages I per cage.
- Diet (e.g. ad libitum): PMI Feeds Inc. Formula # 5008 ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-12 air changes/hour.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Not less than 10% of the total body surface area.
- Type of wrap if used: The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritating adhesive tape. The trunk of each animal was then wrapped with vet wrap which was secured in place with non-irritating adhesive tape to prevent possible ingestion of the test substance.
REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance as possible.
- Time after start of exposure: 24 hours. - Duration of exposure:
- 24 hours
- Doses:
- 1600 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Observations for mortality and clinical/behavioural signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Observations for evidence of dermal irritation were made at approximately 60 minutes after removal of wrapping, and on Days 4, 7, 11 and 14. Individual body weights were recorded just prior to dosing and on Day 7 and 14, or at the time of discovery after dearth.
- Necropsy of survivors performed: yes. On Day 14 after dosing, surviving animals were euthanized by an overdose of CO2. All study animals, whether dying during the study or euthanized, were subject to gross necropsy and all abnormalities were recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 600 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Individual mortality data, including time of death, are presented in Table 1, which is attached as background material. A summary of the incidences:
Dosage (mg/kg), Males, Females, Combined (number dead/number treated)
1600, 0/5, 0/5, 0/10
2000, 3/5, 5/5, 8/10 - Clinical signs:
- other: Prominent in-life observations included activity decrease, hunched posture, prolapsed penis and lateral recumbency. Signs were observed on Days 1 through 14. Clinical signs are presented in Table 2 which is attached as background material.
- Gross pathology:
- Gross necropsy in animals that died on test revealed crusted fur, black skin at test site, discoloured liver and contents of the small intestine, and empty stomach and intestines. Gross necropsy in animals surviving to termination of the study revealed no observable abnormalities. Individual necropsy findings are presented in Table 1, which is attached as background material.
- Other findings:
- Irritation included very slight to severe erythema, very slight to slight oedema, atonia, focal bleeding, coriaceousness, desquamation, eshar, blanching, alopecia, necrosis, ulceration and bruising through Day 14. Signs of dermal irritation are presented in Table 3, which is attached as background material.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Clearlink 1000 was evaluated for its acute dermal toxicity potential and relative skin irritancy by applying it as undiluted single dose to the intact skin of albino rats at dose levels 1600 and 2000 mg/kg. The study was performed in compliance with GLP and the test method was similar to OECD 402 (only two dose levels used instead of required three).
No mortality occurred at the 1600 mg/kg dose level. 3/5 males and 5/5 females died at dose level 2000 mg/kg. clinical signs included activity decrease, hunched posture, lateral recumbency and prolapsed penis. Signs of dermal irritation included erythema, edema, atonia, focal bleeding, coriaceousness, desquamation, eschar, alopecia, blanching, necrosis, ulceration and bruising. 4 animals lost weight during the first week of the study in the 1600 mg/kg dose group, and the only two living animals in the 2000 mg/kg group lost weight during the first week of the study. Abnormal necropsy findings occurred only in the animals dying during the study, and pertained to fur, skin, liver and content of the gastrointestinal tract. The estimated LD50 value for acute dermal toxicity was greater than 1600 mg/kg, but less than 2000 mg/kg. Because the calculation of a single LD50 value is not possible, a conservative approach is taken and 1600 mg/kg bw is selected as a discriminating dose.
The results of this study would lead to the classification of acute oral toxicity (Xn; R21) in accordance with the criteria set in Directive 67/548/EEC. According to EU Regulation No. 1272/2008 (CLP), the classification would be acute tox cat 4; Harmful in contact with skin.
The study is classified as acceptable but as it is conducted with only two doses, instead of the required minimum of three, it does not full fill the guideline requirements. However, it offers important information for evaluation and in the absence of other data, it is used for classification. In addition, according to column 2 of REACH Annex VIII Section 8.5, testing of acute dermal toxicity is not required as Clearlink 1000 has corrosive properties. The result of this study is used as a key value in hazard assessment.
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