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EC number: 619-422-7 | CAS number: 99305-42-7
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-04-13 to 2006-04-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4,4'-Methylenebis(N-butoxycarbonylcyclohexanamine)
- EC Number:
- 619-422-7
- Cas Number:
- 99305-42-7
- Molecular formula:
- C23 H42 N2 O4
- IUPAC Name:
- 4,4'-Methylenebis(N-butoxycarbonylcyclohexanamine)
- Details on test material:
- 4,4'-Methylenebis(N-butoxycarbonylcyclohexanamine) (H12MDU) of Degussa AG, batch 03.10.05/B-6320, purity 89.4 %
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: CBA/Ca
- Sex: female
- Source: Harlan Italy S.r.l., San Pietro al Natisone (UD, Italy)
- Age: 8-12 weeks at time of treatment
- Weight at study initiation: 16.5-18.3 g
- Number of animals: 5 per dose group
- Controls: vehicle (negative)
- Housing: 5 to a cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 15 %
- Air changes (per hr): 15 to 20 per hour
- Photoperiod (hrs dark / hrs light): 12 h light/ 12 h dark
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25, 50 % v/v
- No. of animals per dose:
- 5
- Details on study design:
- 1st application: Induction open epicutaneous
2nd application: Induction open epicutaneous
3rd application: Induction open epicutaneous
ADMINISTRATION/EXPOSURE
- Preparation of test substance for induction: Suspension in vehicle, concentrations 10%, 25%, and 50% v/v.
- Induction schedule:
Days 1, 2, and 3: One daily topical application of 25 µl to the dorsum of each ear.
Day 6: Intraveneous treatment with 3H-methyl thymidine (3HTdR, 250 µl of solution in sterile phosphate buffered saline = 20 µCi),
5 hours later sacrifice and processing of auricular lymph nodes.
Day 7: Determination of 3HTdR incorporation.
- Concentrations used for induction: Each one group with 10%, 25%, and 50% (v/v)
- Positive control: alpha-hexylcinnamaldehyde (25% v/v in vehicle)
EXAMINATIONS
Prior to sacrifice: Body weights (Days 1 and 6),
clinical signs (once daily)
ß-scintillation counting of auricular lymph node cell suspensions for 3HTdR incorporation as disintegrations per minute (DPM) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- STATISTICAL METHODS:
Significance of differences amongst groups was assessed by analysis of variance. Differences between the treated group and the control group were assessed by Dunnetts test using a pooled error variance. Verification of homogeneity by Bartlett's test before Dunnetts test. In case of inhomogeneity: Modified test (Cochran and Cox)
Analysis of variance for differences amongst groups / Dunnett's test for differences in comparison to the control group
Stimulation index (SI) = ratio treated/control of disintegrations per minute (DPM)
Criteria: Sensitizing if SI >= 3 in any treatment group
Results and discussion
- Positive control results:
- In the group of treatment with hexyl cinnamic aldehyd the increase of DPM (9112.2 DPM) was clearly observed. The calculated SI was greater than
3 at the tested dose level (SI= 30.4).
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The stimulation index (SI) was calculated as the ratio of the DPM/treatment group against the DPM/vehicle control group. SI: 16.36 (10% test item); 14.37 (25% test item); 5.09 (50%test item); 30.41 (pos. control)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Group Mean DPM/animal SI Vehicle 299.6 10% test subst. 4902.8 16.36* 25% test subst. 4305.6 14.37* 50% test subst. 1525.0 5.09* pos. control 9112.2 30.41*
Any other information on results incl. tables
RS-Freetext:
RESULTS OF TEST
- Sensitization reaction:
-----------------------------------------------
Group Mean DPM/animal SI
-----------------------------------------------
Vehicle 299.6
10% test subst. 4902.8 16.36*
25% test subst. 4305.6 14.37*
50% test subst. 1525.0 5.09*
pos. control 9112.2 30.41*
-----------------------------------------------
DPM = disintegrations per minute
SI (stimulation index) = DPM (test) / DPM (vehicle)
* p<0.05
-----------------------------------------------
The inverse concentration / effect relationship is tentatively assigned to higher viscosity at higher concentrations leading to
lower penetration.
- Clinical signs: No local irritation at application sites, no signs of systemic effects.
- Body weights: Body weight development was within the expected range.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to the results of the study the test item H12MDU is considered to have the potential to cause skin sensitisation (delayed contact hypersensitivity) under the reported experimental conditions.
- Executive summary:
The potential of the test item H12MDU, to induce and elicit delayed dermal sensitisation was assessed in the mouse using the LLNA test.
Five groups, each of 5 female mice, were treated with the test item at concentrations of 10%, 25%, 50%, with the reference item (alpha-hexylcinnamaldehyde) at the concentration of 25%, and with the vehicle alone.
Increases in 3HTdR incorporation were observed in animals treated with the test item when compared to the negative control group.
No signs of toxicity were observed following dosing animals at all concentrations, indicating a potential systemic effect of the test item. No local irritation was observed at the treatment sites.
Increases in 3HTdR incorporation were clearly recorded in comparison with the negative control group. The calculated SI was higher than 3 at all dose-levels tested. Reliability check was positive as expected.
On the basis of these results, the test item induced a greater than three fold increase in SI at all dose-levels tested. Therefore, it must be concluded that the test item H12MDU is considered to have the potential to cause skin sensitisation (delayed contact hypersensitivity) under the reported experimental conditions.
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