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EC number: 429-270-1 | CAS number: 136210-30-5
- 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 irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 136210-32-7
- EC Number:
- 603-947-3
- Cas Number:
- 136210-32-7
- IUPAC Name:
- 136210-32-7
- Reference substance name:
- Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane
- EC Number:
- 412-060-9
- EC Name:
- Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane
- Cas Number:
- 136210-32-7
- Molecular formula:
- C31H54N2O8
- IUPAC Name:
- bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U. K. Ltd., Wyton, Huntingdon, England
- Strain: HC: NZW
- Sex: females
- Housing: individually
- Nutrition: once per day in the morning
- Water: ad libitum
- Acclimation period: at least 14 days in the quarantine station
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral skin area not treated with test substance served as control.
- Amount / concentration applied:
- 500 µl
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Demal irritation was scored 1, 24, 48 and 72 hours after termination of exposure and furthermore after 7 and 14 days .
- Number of animals:
- 6 females
- Details on study design:
- STUDY DESIGN
The animals were weighed immediately before application of the test substance.
Approximately 24 hours before the test, fur was shorn from the dorso-lateral area of the trunk.
TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: Test substance applicated on a hypoallergenic patch (Beiersdorf No 2342 PV3), the patches loosely held in place with a semiocclusive dressing (Beiersdorf no. 2293).
REMOVAL OF TEST SUBSTANCE
- After an exposure period of 4 hours, the dressing and patches were removed.
- Washing: The exposed skin areas were carefully washed with water without altering the existing response, or the integrity of the epidermis.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 1 - <= 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: mean score: 1.3
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 1 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: mean score: 1.3
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal: #3, #6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean score: 0.3
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: mean irritation index for erythema
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.2
- Max. score:
- 4
- Irritation parameter:
- other: mean irritation index for edema
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- mean irritation index: For each animal the Draize scores recorded 24, 48, and 72 hours after application were added and divided by three. Then the mean value for all animals is calculated.
- Other effects:
- not reported
Any other information on results incl. tables
Study was performed with Aspartic acid, N,N'-[methylenebis(2-methyl-4,1-cyclohexanediyl)]bis-, 1,1',4,4'-tetraethyl ester which is a structural analogue to Aspartic acid, N,N'-(methylenedi-4,1-cyclohexanediyl)bis-, 1,1',4,4'-tetraethyl ester. Both substances are diethyl esters of aspartic acid linked to a dicyclohexylmethyldiamine moiety. The difference between these two substances is merely the presence of two methyl groups connected to the cyclohexane rings. This structural analogy was confirmed by the Member State responsible for the notification of both substances under the NONS regulation. The Member State decided that test results obtained for one substance can be transferred to the other substance and that testing of both substances is usually not required. This decision is in accordance with the grouping of substances and read-across approach in Annex XI, 1.5 of the REACH Regulation.
Applicant's summary and conclusion
- Executive summary:
In an OECD TG 404 study aspartic acid, N,N'-[methylenebis(2-methyl-4,1-cyclohexanediyl)]bis-,1,1',4,4'-tetraethyl ester was applied under semiocclusive dressings for 4 hours to the intact but shaved skin of a group of 6 female rabbits. Skin irritation was assessed after 1, 24, 48, 72 hours and 7 and 14 days using the Draize scale. The mean irritation index for erythema was 1.2 of max. 4 (1.0 -1.99 = slight irritating), the mean irritation index for edema was 0 of max. 4. Signs did not prove to be fully reversible in all animals within one week, and in one animal within 14 days (still erythema score 1). The weight of these evidences indicates that the test substance may be considered as "slightly to moderately irritating to the skin".
No systemic signs were reported.
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