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EC number: 480-240-4 | CAS number: 185257-07-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- 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:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The study is performed based on the method of Magnusson, B. and Kligman, A.M.: The
Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximization Test. J.
Invest. Dermatol. 52, 268 - 276 (1969). - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Name of test substance: MGDN
Test-substance No.: 06/0116-1
Batch identification: Betriebsware C404
Purity: 99.5 area-%
Physical state: solid
Homogeneity: The test substance was homogeneous by visual inspection.
Storage condition of test material: room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc: DH
- Sex:
- female
- Details on test animals and environmental conditions:
- Age at day 0: 6-7 weeks.
Supplier: Harlan Winkelmann GmbH, Gartenstr. 27, 33178 Borchen, Germany
Acclimatization period: 7 days.
Identification: Ear tattoo
Body weight at day 0: 305 g – 358 g
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 – 24°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
Day / night rhythm: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Type of cage: Stainless steel wire mesh cages with plastic-coated grating, minimum floor area: 2,000 cm2
Number of animals per cage: 5
Feeding: Kliba Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland ad libitum
Drinking water: Tap water ad libitum.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- Intradermal induction: test substance 2.5% in 1% aqueous CMC-solution or in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1:1).
Epicutaneous induction: test substance 50% in 1% aqueous CMC-solution.
Challenge: test substance 50% in 1% aqueous CMC-solution.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- Intradermal induction: test substance 2.5% in 1% aqueous CMC-solution or in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1:1).
Epicutaneous induction: test substance 50% in 1% aqueous CMC-solution.
Challenge: test substance 50% in 1% aqueous CMC-solution.
- No. of animals per dose:
- Test group: 10
Control group: 5 - Details on study design:
- The study consists of pretests and a main test. The concentrations for the test substance suitable for use in the main experiment were determined in the pretests.
Clipping of the fur: At least 2 hours before each test-substance application at the appropriate application sites. If necessary, additionally at least 2 hours before evaluation of the skin reactions.
Body weight determination: Individual body weights on day 0 and at the last day of observation.
Mortality: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
Illumination used for reading: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany).
Main test: Induction
Intradermal induction: 6 intradermal injections in groups of two per animal were given.
Injections for the control group:
A) front row: 2 injections each of 0.1 mL Freund’s complete adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 mL of the undiluted vehicle
C) back row: 2 injections each of 0.1 mL of a 50% formulation of the vehicle without test substance emulsified with Freund’s complete adjuvant* / 0.9% aqueous NaCl-solution (1 : 1)
Injections for the test group: Analogously to the intradermal pretest.
Application site: neck region.
Readings: 24 h after the beginning of application
Epicutaneous induction: Epicutaneous induction was carried out one week after intradermal induction.
Amount applied: 1 mL of the test-substance preparation was applied to each animal.
Occlusive dressing: 2 x 4 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test-substance preparations were applied to the skin of the neck region under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 6 cm from Russka), and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
Duration of exposure: 48 hours
Application site: Neck region, same area as in the case of the previous intradermal application
Readings: Directly after removal of the patch
The control animals were not treated since the 1% aqueous CMC-solution used as formulating agent was not expected to influence the result of the study.
The challenge was carried out 14 days after the epicutaneous induction.
Amount applied: 0.5 mL of the test-substance preparation was applied to each animal. The test group and control group were treated with the testsubstance preparation.
Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test-substance preparation were applied to the skin of the flank under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
Duration of exposure: 24 hours
Application site: Intact flank
Readings: 24 and 48 h after the removal of the patch - Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Statistics:
- not applicable
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% in the challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0% in the challenge. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in the challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in the challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% in the challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% in the challenge. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in the challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% in the challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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