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EC number: 270-192-0 | CAS number: 68412-48-6
- 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 irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 August 1983 to 12 August 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP reguations of the FDA effective 20/06/1979.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Propanone, reaction products with diphenylamine
- EC Number:
- 270-192-0
- EC Name:
- 2-Propanone, reaction products with diphenylamine
- Cas Number:
- 68412-48-6
- Molecular formula:
- Variable.
- IUPAC Name:
- N-cyclohexylcyclohexanamine; propan-2-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Source: UNIROYAL, INC.
Date Received: 28/07/1982
Label: Aminox CN 5731
Storage: The test article was stored at ambient room temperature and humidity.
Description of test article: Yellow powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Six healthy albino rabbits were selected for this test from a larger group which had been quarantined at least one week. The animals were received from Nichol as Helf on 23/07/1983 and 30/07/1983.
Animals were identified by cage notation and with a uniquely numbered metal ear tag. The animals were housed 2 per cage in suspended wire mesh cages. Bedding was placed beneath the cages. Fresh Purina Rabbit Chow (Diet #53-21) and water were freely available.
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled and kept clean and vermin free.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Mazola oil
- Controls:
- no
- Amount / concentration applied:
- Six healthy albino rabbits were dosed dermally with Aminox CN 5731 0.5 g of the test article was applied to 1 intact and 1 abraded site on the clipped back for a total dose of 1.0 g/rabbit
- Duration of treatment / exposure:
- Exposure time: 72 hours
- Observation period:
- The skin reactions were observed 24 and 72 hours after dosing.
- Number of animals:
- Six
- Details on study design:
- Preparation of test site
Prior to application of the test article, the back and sides of each animal were clipped free of hair. The left side of each animal was abraded with a bent tip needle. Three abrasions, approximately 2-3 cm apart, extending the length of the exposure site were made. The abrasions were sufficiently deep to penetrate the stratum corneum, but not deep enough to produce bleeding. The right side of wach animal remained intact.
Experimental design
The test article was applied to two areas, 1 intact and 1 abraded, on the prepared site, on the back of each of the six rabbits. Test substance was applied as 50% weight/volume mixture in a suitable vehicle and dosed by dry weight. 0.5 g/site for a total dose volume of 1.0 g/rabbit. Test article was covered with 2.5 cm square gauze patches which were secured with adhesive tape. The torso was wrapped with plastic which was secured with adhesive tape. The sites were occluded for 24 hours at which time the patches were removed.
Type and frequency of observations
Animals observed for skin reactions at 24 and 72 hours after application of the test article. Erythema and edema were scored according to the numerical Draize technique. Additional signs and general health of the animals was monitored at each observation time.
Analysis of data
The Primary Irritation Index was calculated by adding the mean values (6 rabbits) for erythema/eschar and edema on intact and abraded skin at 24 and 72 hours (a total of 8 values) and dividing the sum by 4.
A primary irritant is defined as a substance which is not corrosive but which results in an empirical score of 5 of more.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Erythema was minimal at 24 hours and was absent to slight at 72 hours. No odema was observed.
- Other effects:
- None specified.
Any other information on results incl. tables
Individual scores
|
Rabbit Number |
Mean score |
|||||
|
A9707 |
A9774 |
A9775 |
A9777 |
A9778 |
A9779 |
|
Erythema & Eschar Formation |
|
|
|
|
|
|
|
Intact skin – 24 hours |
1a |
0a |
0a |
1a |
1a |
1a |
0.67 |
Intact skin – 72 hours |
2a |
0a |
1a |
1a |
1a |
1a |
1.00 |
Abraded skin – 24 hours |
1a |
0a |
0a |
1a |
1a |
1a |
0.67 |
Abraded skin – 72 hours |
2a |
1a |
1a |
1a |
1a |
1a |
1.17 |
Edema |
|
|
|
|
|
|
|
Intact skin – 24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Intact skin – 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded skin – 24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded skin – 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
Sum of mean scores = |
3.51 |
||
|
PRIMARY IRRITATION INDEX = SUM OF MEAN SCORES/4= |
0.88 |
Key:
a = test article remaining on treated site
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: 16 CFR 1500.3(c)(4)
- Conclusions:
- The Primary Irritation Index is 0.88. Therefore, the test article is a non-irritant as defined in 16 CFR 1500.3(c)(4).
- Executive summary:
The objective of the study was to determine the dermal irritation potential of Aminoz CN 5731. Study was conducted in accordance to GLP and test guidline 16 CFR 1500.41. Results of the study concluded that the mean primary irritation idex is 0.88 for the test article. Erythema was minimal at 24 hours and was absent to slight at 72 hours. No odema was observed. Therefore to conclude, the test article is classified as a not irritating under 16 CFR 1500.3(c)(4)
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