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Diss Factsheets
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EC number: 222-001-7 | CAS number: 3312-60-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03. June 2020 to 09. July 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-cyclohexylaminopropylamine
- EC Number:
- 222-001-7
- EC Name:
- 3-cyclohexylaminopropylamine
- Cas Number:
- 3312-60-5
- Molecular formula:
- C9H20N2
- IUPAC Name:
- N1-cyclohexylpropane-1,3-diamine
- Test material form:
- liquid
- Details on test material:
- 3-Cyclohexylaminopropylamine from Evonik Corporation, Batch: 2266445
Constituent 1
In vitro test system
- Test system:
- other: synthetic biobarriers
- Justification for test system used:
- 150 μl of the test article were added to the CDS reagent in a Qualify vial, and the vial
was observed for any notable color change. An observable color change indicates that the test article is compatible with the Corrositex® system - Details on test system:
- TEST SYSTEM
Identity : Corrositex®Kit
Supplied by : InVitro International, Placentia, CA
Lot Numbers : CT 110419, CT 040119
Dates Received : 01 May 2020, 12 Jun 2020
Expiration Dates : Nov 2021, Apr 2021
Storage : Biobarriers – refrigerated at 2-8ºC.
Other kit components – room temperature and humidity
QUALIFICATION
For each test article, 150 μl of the test article were added to the CDS reagent in a Qualify vial, and the vial was observed for any notable color change. An observable color change indicates that the test article is compatible with the Corrositex® system.
METHOD
- The test articles were qualified and found to be compatible with the Corrositex® test system.
- The test articles were categorized by pH.
- For each test article, 500 µl of the test article were added to the Corrositex® test vials containing biobarriers and the time required for each test article to destroy the biobarrier was recorded.
- A Positive Control (1.0 N Sodium Hydroxide) and a
- Negative Control (1 % Citric Acid) were tested concurrently.
The mean breakthrough lime, which predicts the in vivo corrosive potential of each test article, was used to designate the United Nations (U.N.) Packing Group classifications.
CATEGORISATION
Next, each test article was categorized, which determined cut-off times for the Packing Group designations. A 10% formulation of each test article was prepared and its pH was measured. If the pH of the 10% formulation was <7.0, 150 μl of the neat test article were added to Vial A. The pH of Vial A was then measured, and if it was < 5.0, the test article was assigned to Category 1, and if it was >5.0, the test article was assigned to Category 2. If the pH of the 10% formulation was > 7.0, 150 μl of the neat test article were added to Vial B. The pH of Vial B was measured, and if the final pH was > 9.0, the test article was Category 1, and if it was < 9.0, the test article was Category 2.
CLASSIFICATION
Finally, each test article was classified to determine the Packing Group by adding 500 μl of the test article to each of four test vials containing biobarriers. If the test article penetrates or destroys the biobarrier, it will come in contact with the CDS reagent in the vial and induce a color change similar to that observed in the Qualify vial. The amount of time required for the test article to penetrate or destroy each biobarrier was recorded and the mean time of the four replicates was used to designate the United Nations (U.N.) Packing Group classification and GHS Sub-category as described below. A positive control was performed using 1.0 N sodium hydroxide. The result for the positive control is considered valid if it falls within the range of the MB Research historical mean ± 2 standard deviations. A negative control was performed using 1% citric acid; the result is considered valid if the breakthrough time is greater than 60 minutes. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 500 µl
- Duration of treatment / exposure:
- 42,02/ 46,30/ 45,47/ 42,95 min = mean time 44,19 min
- Number of replicates:
- 4
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Value:
- 44.19
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: CATEGORISATION: pH of 10 % solution =12, pH in vial B = 12, Category 1; CLASSIFICATION: Packing group II, moderate corrosivity, GHS Sub Category 1B
Any other information on results incl. tables
Breakthrough Time (minutes) | ||||
Category 1 | 0 to 3 min | > 3 to 60 min | > 60 to 240 min | > 240 min |
Category 2 | 0 to 3 min | > 3 to 30 min | > 30 to 60 min | > 60 min |
Packing Group I | Packing Group II | Packing Group III | Non-corrosive | |
Severe Corrosivity | Moderate Corrosivity | Mild Corrosivity | ||
GHS Sub-category 1A | GHS Sub-category 1B | GHS Sub-category 1C |
Applicant's summary and conclusion
- Conclusions:
- A Corrositex test with test item resulted in a mean breakthrough time of 44,12 min, and assignment of GHS Category 1B skin corrosivity and UN packaging group II classifications.
- Executive summary:
The test articles were analyzed using the Corrositex® test method to determine their dermal corrosivity potential and Packing Group designations.
The 1.0 N Sodium Hydroxide Positive Control had a breakthrough lime of 20,3 and 18,47 minutes, which fell within the range allowed (>13.6 and <22.0 minutes).
The 1% Citric Acid Negative Control had a breakthrough time of >70,03 ans 65,73 minutes, which met the acceptance criterion of >60 minutes.
The results of this study indicated that the test articles were compatible with the Corrositex® system. The mean times required to destroy the synthetic biobarriers and the Packing Group classifications of these test articles are listed in Tables below.
Categorization Results
Test Article ldentity
Conc. Tested
pH of
10% (v/v) solution
pH in
Tube B
Category
Test item
10%
12
12
1
Classification Results
Test Article ldentity
BreakthroughTime (minutes)
Packing Group
Corrosivity
Mild
1
2
3
4
Mean
Test item
42,02 46,30
45,47
42,95
44,19
Packing Group II
Conclusion:
A Corrositex test with test item resulted in a mean breakthrough time of 44,19 min, and assignment of GHS Category 1B skin corrosivity and UN packaging group II classifications.
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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