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EC number: 225-063-3 | CAS number: 4637-24-5
- 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 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: OECD guideline study conducted in accordance to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1,1-dimethoxytrimethylamine
- EC Number:
- 225-063-3
- EC Name:
- 1,1-dimethoxytrimethylamine
- Cas Number:
- 4637-24-5
- Molecular formula:
- C5H13NO2
- IUPAC Name:
- 1,1-dimethoxy-N,N-dimethylmethanamine
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- The intradermal and the epicutaneous induction were performed with a 1% test substance preparation in paraffin, highly liquid. For the first challenge a 0.1% test substance preparation in paraffin, highly liquid was chosen. The second challenge was performed with a 0.05% test substance preparation in polyethylene glycol.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- The intradermal and the epicutaneous induction were performed with a 1% test substance preparation in paraffin, highly liquid. For the first challenge a 0.1% test substance preparation in paraffin, highly liquid was chosen. The second challenge was performed with a 0.05% test substance preparation in polyethylene glycol.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control
- Dose level:
- polyethylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. Dose level: polyethylene glycol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control
- Dose level:
- polyethylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. Dose level: polyethylene glycol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05% test substance preparation in polyethylene glycol
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- discrete (3/10 animals) up to moderate and confluent eryhema (3/10 animals)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.05% test substance preparation in polyethylene glycol. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: discrete (3/10 animals) up to moderate and confluent eryhema (3/10 animals).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05% test substance preparation in polyethylene glycol
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy eryhema (1/10 animals)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.05% test substance preparation in polyethylene glycol. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy eryhema (1/10 animals).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of this study it was concluded that N, N-Dimethylformamide dimethyl-acetal has a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
- Executive summary:
After the first challenge interpretation of the results was complicated by the interference of primary skin irritation effects induced by the vehicle paraffin oil, which led to very similar high incidences of skin reactions in control group 1 and the test group at the test substance treated application sites. Very high incidences of skin reaction at the vehicle treated application sites were observed in all groups, additionally. In order to enhance evaluation, a second challenge was performed using another vehicle (Lutrol E 400). As after the second challenge no skin reactions occurred in the control groups but 6 of 10 animals in the test group showed findings, the test substance is considered to possess a skin sensitizing potential. Reactions in some animals of the test group at the vehicle treated application site indicate a possible influence of the induction treatment by the test substance on the skin irritation threshold.
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