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EC number: 619-764-7 | CAS number: 173904-11-5
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-10-06 to 2011-01-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in accordance with GLP regulations and OECD/EU guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (2-methylpropylidene)[(3-{[(2-methylpropylidene)amino]methyl}cyclohexyl)methyl]amine
- EC Number:
- 619-764-7
- Cas Number:
- 173904-11-5
- Molecular formula:
- C16H30N2
- IUPAC Name:
- (2-methylpropylidene)[(3-{[(2-methylpropylidene)amino]methyl}cyclohexyl)methyl]amine
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl(WI)Br
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Hygienic level: SPF at arrival and kept in a good conventional environment during the study
- Justification of strain: The Wistar rats as a rodent is one of the standard species of acute toxicity studies.
- Number of animals: 5 animals/sex
- Age of animals: Young adult rats, 8 weeks old
- Body weight range (male): 282-292 g
- Body weight range (female): 261-276 g
- Acclimatisation time: 5 days
Animal Husbandry:
- Animal health: Only healthy animals were used for the study. The health status was certified by the breeder.
- Number of animal room: 5
- Housing: during acclimatization: 3 animals/sex/cage During the study: animals were housed individually.
- Cage type: Type II polypropylene/polycarbonate; rat type cages with a solid floor, stainless steel wire covers and self-feeding baskets.
- Illumination: Artificial light, from 6 a.m. to 6 p.m.
- Temperature: 22 ± 3 °C
- Relative humidity: 30 - 70 %
- Ventilation: 8-12 air exchanges/hour by central air-condition system.
- Environmental conditions were maintained by an air-conditioning system.
- Temperature and relative humidity were verified and recorded daily during the study. Before housing the animals the microbiological status of the room was checked.
- Food and water supply: The animals received ssniff® SM R/M-Z+H complete diet produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum. Animals received tap water from watering bottles ad libitum.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The back of animals was shaven (approximately 10 % area of the total body surface) 24 hours prior to the treatment. The test item was applied in a single dose uniformly at least 10 % area of the total body surface throughout a 24-hour exposure period. Sterile gauze pads were placed on the skin of rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped with semi-occlusive plastic wrap for 24 hours. At the end of the exposure period, residual test item was removed, using body temperature water.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males/5 females per dose
- Control animals:
- no
- Details on study design:
- Dose Level: The test item was not expected to be lethal at 2000 mg/kg bw. A limit test was performed.
A single administration was performed by dermal route and was followed by a 14-day observation period.
Observations
Mortality
Inspection for signs of morbidity and mortality were made twice daily at the beginning and end of the working day.
Clinical Observations
Animals were observed individually 1 h and 5 h after dosing, and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body weight
The body weight were recorded on day 0 (shortly before the treatment), at day 7 and at day 15 on all animals with a precision of 1 g.
Pathology
All animals were subjected to gross pathology. All animals were exsanguinated under isoflurane anaesthesia. After examination of the external appearance the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathological changes were recorded for each animal on the post mortem record sheets. - Statistics:
- NA
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Inspection for signs of morbidity and mortality were made twice daily at the beginning and end of the working day.
No mortality occurred after the 24-hour dermal exposure to Incorez 397 in Crl:(WI)BR male and female rats during the study. - Clinical signs:
- other: Animals were observed individually 1 h and 5 h after dosing, and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomo
- Gross pathology:
- No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy. The external alterations (dry skin surface, crusting) were in line the observed local irritant symptoms.
- Other findings:
- It is to be noted that the test item caused dermal irritation response on the site of administration.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the acute dermal LD50 value of the test item Incorez 397 proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats. On the other hand, it is to be noted that the test item caused dermal irritation response on the site of administration.
- Executive summary:
An acute dermal toxicity study was performed with test item Incorez 397 in Crl:(WI)BR rats, in compliance with OECD Guideline No.: 402, Directive 92/69 EEC B.3 and OPPTS 870.1200.
A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to Incorez 397 at 2000 mg/kg bw by dermal route. The test item was applied in original form and left in contact with the skin for 24 hours, followed by a 14-day observation period.
No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item caused dermal irritation symptoms as slight to severe erythema, very slight oedema and other signs (dry skin surface, wounds, crusting) during 14-day observation period.
Slight body weight loss was observed in one female on first week. It could not be evaluated as a toxic effect of test item.
No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy. The external alterations (dry skin surface, crusting) were in line the observed local irritant symptoms.
Under the experimental conditions of this test, the acute dermal LD50 value of the test item Incorez 397 proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.
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