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EC number: 402-130-7 | CAS number: 106246-33-7
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
This substance has been notified as new chemical substance und the previous European chemicals legislation (ELINCS). A standard data set was provided at that time. In addition, a 90-day repeated oral toxicity study was conducted for a planned Food Contact registration. The standard Annex 8 data requirements consist of a reproduction toxicity screening test. However, as a 90-day oral toxicity study is already available and the 100 tpa tonnage threshold was exceeded, the registrant suggest to conduct a developmental toxicity / teratogenicity on rats (according to OECD 414) to fulfill the Annex 9 data requirements of the REACH-regulations. If a subchronic 90-day oral toxicity study is already available, a developmental / teratogenicity test is preferred instead of a reprotoxicity screening study according to OECD 421 or 422.
NON-CONFIDENTIAL NAME OF SUBSTANCE ON WHICH TESTING IS SUGGESTED TO BE CARRIED OUT:
- 4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)
- EC-Number: 402-130-7
- CAS-Number: 106246-33-7
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
1. AVAILABLE GLP-STUDIES:
Complete study package (GLP) of ELINCS-notification dossier incl. prolonged oral toxicity studies on rats over 28 and 90 days; no information about reproductive or developmental toxicity available, as those endpoints were not required at time of notification/registration. All studies are of good quality (Klimisch 1), GLP-compliant and conducted according to OECD- and/OR EU-testing methods.
2. SUITABLE ALTERNATIVE OR (Q)SAR TESTING METHODS:
Suitable (in-vitro) testing or QSAR-methods are not available
3. AVAILABLE NON-GLP STUDIES:
Non-GLP studies on developmental toxicity/teratogeniciy are not available
4. HISTORICAL HUMAN DATA
Historical human data are not availalable
5. GROUPING/READ-ACROSS APPROACH:
A possible read-across approach to the following structurally similar substance (same chemical structure, but without Cl-atoms) was initially taken into consideration:
Non-Confidential Name of possible Read-Across Substance:
- 4,4'-Methylenebis[2,6-diethylaniline]
- EC number: 237-185-4
- CAS number: 13680-35-8
- Registered by same applicant
For this substance, an annex 9 REACH-data set incl. OECD 414 on rats is already available and a study on a second species (rabbit) is currently ongoing. However, a comparison of all results and toxicity endpoints of source and target substances showed, that the two chemicals are not that similar as expected and have a rather different toxicity profile with deviating solubility properties in water and n-octanol:
- Different phys-chem characteristics: CAS 106246-33-7 is ca. 20-fold less soluble in water than the read-accross candidate CAS 13680-35-8), and has a much higher Log Pow; although both would be characterised as of low water-solubility and high lipophilicity.
- The substance in question (CAS 106246-33-7) is classified for oral acute toxicity (LD50 < 2000 mg/kg), whereas the possible read-accross substance (CAS 13680-35-8) is not (LD50 > 5000 mg/kg)
- While the main target organ in the subchronic studies appears the same, liver, the histopathology is different.
Finally, we came to the conclusion, that the criteria for sameness are not fulfilled and therefore, a read-accross to CAS number 13680-35-8 is not possible. As consequence, we suggest to conduct an OECD 414 with 4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline) (EC-Number: 402-130-7 / CAS-Number: 106246-33-7)
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- -
- EC Number:
- 402-130-7
- EC Name:
- -
- Cas Number:
- 106246-33-7
- Molecular formula:
- C21 H28 Cl2 N2
- IUPAC Name:
- 4-[(4-amino-2-chloro-3,5-diethylphenyl)methyl]-3-chloro-2,6-diethylaniline
- Test material form:
- solid: crystalline
- Details on test material:
- - Name: LONZACURE® M-CDEA
- Internal substance code: P5367
- Storage: Keep container tightly closed. Keep in a dry, cool and well-ventilated place.
- Aggregate state/appearance: Crystalline solid
- Colour: white to off-white
- Odour: Odourless
Constituent 1
Test animals
- Species:
- rat
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.