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EC number: 211-743-7 | CAS number: 693-13-0
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Justification for type of information:
- See the full article in the attachement.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Mouse Ear Swelling Test:
Dose dependent contact hypersensitivity responses to both DCC and DIC were demonstrated by the MEST. Sensitizing concentrations as low as 0.006% DCC produced significant ear swelling 24 and 48 hr after application compared to the background control group (Fig 4). Similarly, sensitization with concentrations as low as 0.3% DIC produced a significant increase in percent ear swelling 24 hrs post challenge. By 48 hrs post challenge, 1.5% DIC was the lowest concentration producing a statistically significant response (Fig 5). No significant differences were seen in body weight changes between animals dosed with vehicle or test article in any of the MEST studies. The positive control groups experienced a significant increase in percent ear swelling as compared to the background positive at both the 24 and 48 hr time points (representative studies are shown in Figs 4 and 5). - GLP compliance:
- not specified
- Type of study:
- mouse ear swelling test
- Justification for non-LLNA method:
- Furthermore, the MEST was a more effective indicator of sensitization potential than the LLNA in these studies. In conducting this battery of assays for numerous years, no pattern has occurred with regards to the sensitivity of LLNA vs. the MEST. There has been a positive correlation between these assays at highly sensitizing concentrations, but at lower concentrations the sensitivity of these assays varies,between chemicals. For these carbodiimides, the murine models of irritation and hypersensitivity used in this study correlate well with reported human case studies.
Test material
- Reference substance name:
- N,N'-methanetetraylbis(1-methylethylamine)
- EC Number:
- 211-743-7
- EC Name:
- N,N'-methanetetraylbis(1-methylethylamine)
- Cas Number:
- 693-13-0
- Molecular formula:
- C7H14N2
- IUPAC Name:
- (propan-2-yl)({[(propan-2-yl)imino]methylidene})amine
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- female
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
- Details on study design:
- The Mouse Ear Swelling Test (MEST) followed the original procedure described by Gad et all0 with only minor modifications. Prior to dosing, mice were weighed, tattooed, and anesthetized so the dorsal lumbar area of each mouse could be shaved. Initial concentrations of DCC and DIC evaluated were the O.lMNC, OSMNC, and MNC. Lower concentrations were tested when necessary to elicit a no-effect level (Table I). Beginning on day I, 50 p1 of test article or vehicle was applied to the shaved site of each animal. The same procedures were repeated for two more days and then the mice were left untreated for four days (days 4-7). On day 8, right ear thickness of each mouse was measured in duplicate and averaged prior to challenge. After measurement, mice were challenged with 12.5 pl of vehicle or test article (MIC concentration) on the dorsal and ventral surfaces of the right ear pinna. The right ear then was measured in duplicate 24 and 48 hours (i2 hr) after challenge and averaged. The percent ear swelling was calculated for each time point as described for the imtancy assay. Mean percent ear swelling for each dose group was compared to the mean percent ear swelling for the background control (BC, sensitization with acetone and challenge with MIC) for significance and dose response. The BC group was used as the control to account for swelling caused by irritation.
- Challenge controls:
- After measurement, mice were challenged with 12.5 pl of vehicle or test article (MIC concentration) on the dorsal and ventral surfaces of the right ear pinna.
- Positive control substance(s):
- yes
- Remarks:
- 1-fluoro-2,4 dinitrobenzene
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.03%, 0.15%, 0.3%, 1.5%, 3%
- Clinical observations:
- Sensitization with concentrations as low as 0.3% DIC produced a significant increase in percent ear swelling 24 hrs post challenge
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Skin Sens 1 H317
Dose dependent contact hypersensitivity responses to DIC were demonstrated by the Mouse Ear Swelling Test (MEST). - Executive summary:
Skin Sens 1 H317
Sensitizing concentrations as low as 0.006% DCC produced significant ear swelling 24 and 48 hr after application compared to the background control group (Fig 4). Similarly, sensitization with concentrations as low as 0.3% DIC produced a significant increase in percent ear swelling 24 hrs post challenge. By 48 hrs post challenge, 1.5% DIC was the lowest concentration producing a statistically significant response (Fig 5). No significant differences were seen in body weight changes between animals dosed with vehicle or test article in any of the MEST studies. The positive control groups experienced a significant increase in percent ear swelling as compared to the background positive at both the 24 and 48 hr time points (representative studies are shown in Figs 4 and 5).
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