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Diss Factsheets
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EC number: 500-062-3 | CAS number: 28390-91-2
- 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
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- 4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline] is methylenebisbenzenamine with four epoxy groups and is considered as a monoconstituent substance under REACH with a purity > 80% and containing the following impurities: triglycidyl-(2-hydroxy-3-chloropropyl)-methylenedianiline in a range of 3.5 to 4%, dimeric TGMDA in a range of 3 to 5%, triglycidyl-(2,3-dihydroxypropyl)-methylenedianiline in a range of 0.3 to 1%, triglycidyl-(2-hydroxypiperidine)-methylenediamine in a range of 0.5 to 1%, triglycidyl methylenedianiline in a range of 0.3 to 0.8%, (2-hydroxy-3-chloropropyl)-dimeric TGMDA in a range of 0.2 to 0.6%, and trimeric TGMDA in a range of 0.2 to 0.5%. The hypothesis is to read-across some data from the monoconstituent substance described above to the corresponding UVCB substance as described under REACH. The UVCB substance being chemically similar and just differ from the monoconstituent substance by the purity of the main constituent which is < 80% but still stay in the same order of magnitude. The impurities from the monoconstituent substance being also present in the same order of magnitude in the UVCB substance containing also two additional substances, 2-oxiranemethanamine, %{N}-[4-[[4-[[3-chloro-2-(oxiranylmethoxy)propyl](oxiranylmethyl)amino]phenyl]methyl]phenyl]-%{N}-(oxiranylmethyl)- in a range of 0.5 to 2 % and less than 1% 1-[(4-{4-[bis(oxiran-2-ylmethyl)amino]benzyl}phenyl)(oxiran-2-ylmethyl)amino]-3-[(4-{4-[(3-chloro-2-hydroxypropyl)(oxiran-2-ylmethyl)amino]benzyl}phenyl)(oxiran-2-ylmethyl)amino]propan-2-ol. The main assumption is that the minor differences in terms of percentage between the mono and UVCB substance are not significant in respect of all properties under consideration. The full report on read-across approach is attached in section 13 of the IUCLID file.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 3 male rabbits, weighing 2 - 3 kg (12 - 14 weeks old), were individually housed in metal cages, identified with ear tags, and kept at constant temperature of 20 +/- 3 °C, a relative humidity of 30-70% and at a 12 hour dark/light cycle. m They received diet and water ad libitum Body weight was recorded on days 0, 3, and 7 of the test.
Test system
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 grams per flank of 6 cm2
- Duration of treatment / exposure:
- 4 hours with a semi-occlusive bandage
- Observation period:
- Observation was daily.
Skin reactions and signs of toxicity were recorded at 1 hour, 24, 48, 72 hours , and daily afterwards, - Number of animals:
- three male rabbits
- Details on study design:
- Irritation / corrosion was classified according to EEC guideline 83/467/1983 (Appendix 2).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- > 0.3 - < 0.4
- Max. score:
- 1
- Reversibility:
- fully reversible within: after 7 days
- Remarks on result:
- other: max. score = 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- > 0.3 - < 0.4
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: max. score = 4
- Irritant / corrosive response data:
- The resposnses were mild and the average from 3 animals was lower than minimum for classification and labelling
- Other effects:
- Body weight development was not adversely affected by the treatment
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Although there was erythema in 2/3 animals and oedema in 1/3 animals with a minimum score of 1, the mean value was below the threshold for classificaiton and labelling
- Executive summary:
Although there was erythema in 2/3 animals and oedema in 1/3 animals with a minimum score of 1, the mean value was below the threshold for classification and labelling; the test material is minimally irritating to skin
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.
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