Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 944-968-0 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
Sensitisation
In a Delayed Contact Hypersensitivity Study in Guinea Pigs the test material was not found to be a skin sensitizer. It may be predicted from this that (analogue read-across) the registered substance would share a similar toxicity profile and would also not be predicted to be a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to Buehler protocol which satisfies the citeria of toxic control act (40 CFR) and the OECD Guideline, GLP, well documented
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Conducted to general conditions satisfying the OECD Guideline
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted in 1990 before the requirement to use the LLNA became mandatory.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: approved supplier
- Weight: 374-623g
- Housing: wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum, PURINA GUINEA PIG CHOW
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least four days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h each - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80/20 ethanol/dest water; acetone
- Concentration / amount:
- Pilot: 100% (without vehicle), 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% (partly in 80/20 ethanol/dest water)
Main study Induction: 5% (in 80/20 ethanol/dest water)
Challenge: 2.5% (in acetone) - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80/20 ethanol/dest water; acetone
- Concentration / amount:
- Pilot: 100% (without vehicle), 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% (partly in 80/20 ethanol/dest water)
Main study Induction: 5% (in 80/20 ethanol/dest water)
Challenge: 2.5% (in acetone) - No. of animals per dose:
- Main study test group: 10 males and 10 females
Main study control group: 5 males and 5 females - Details on study design:
- RANGE FINDING TESTS:
Primary irritation 8 male and 8 female animals were used.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Frequency of applications: once a week
- Concentrations: 5%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction exposure
- Exposure period: 6h
- Test groups: 10 animals per gender
- Control group: 5 animals per gender
- Concentrations: 2.5%
- Evaluation (hr after challenge): 24hr - Challenge controls:
- 5 animals per gender were used as control, no positive control is reported
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Only grade ± reactions comparable to the controls were observed. The test substance is considered not to be a skin sensitizer..
- Executive summary:
The potential of the test item, as a 5% w/v formulation in 80% ethanol/20% distilled water, to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler.
Following primary challenge, there were no grades of 1 produced in the test or control animals. The incidence of grade + responses in the test group (14 of 20) was compared to that of the naive control group (7 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group indicating that sensitization had not been induced.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across hypothesis proposed is that the organism is not exposed to common compounds but rather, as a result of structural similarity, that different compounds have similar toxicological and fate properties. In this case the ECHA Read-Across Assessment Framework (RAAF) Scenario 2 is used.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: N,N-Dimethyldecan-1-amide, mixture with N,N-Dimethyloctanc-1-amide [CAS 67359-57-3]
Target: Reaction Mass of N,N-Dimethyldodecanamide and N,N-Dimethyltetradecanamide [EC not assigned; CAS not assigned]
3. ANALOGUE APPROACH JUSTIFICATION
It may be concluded that both the registered substance (target) and the source molecules can be regarded as close structural analogues having both similar physical chemical and toxicological properties. It follows that where endpoints for the registered substance may not have experimental evidence, particularly those involving animal studies, that these can be addressed by read across grouping using an analogue approach. It is therefore proposed that, after careful assessment, experimental data from the source molecules may be used as surrogate evidence for read across to the registered substance. Please refer to attached document for information on the data available to support the read-across.
4. DATA MATRIX
Please refer to attached document - Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Group:
- positive control
- Remarks on result:
- not measured/tested
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No studies are available which investigate the skin sensitising potential of Reaction mass of N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide. Data are available from an analogue.
A test with a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyldodecanamide and N,N-dimethylhexanamide) for skin sensitisation was done using an adaptation of the method of Ritz and Buehler* (Stepan 1990, J.J Kreuzmann).The test substance was used as 5% w/v formulation in 80% ethanol/20% distilled water for induction and as 2.5% formulation in acetone for challenge and epicutanueous occlusive applied to 20 guinea pig. There were no grades of 1 produced in the test or control animals. The incidence of grade + responses in the test group (14 of 20) was compared to that of the naive control group (7 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group indicating that sensitization had not been induced. Therefore the mixture was classified as not sensitising.
The results of this study are read across to the registered substance, Reaction mass of N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide.
* Study according to Buehler protocol which satisfies the criteria of toxic control act (40 CFR) and the OECD Guideline, GLP.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
Skin sensitisation was not observed in a skin sensitisation guinea pig study (buehler protocol; mixture of dimethylamides): The scores obtained from the study led to no classification for skin sensitisation according to GHS (Regulation (EU) 1272/2008). It may be predicted from this that (analogue read-across) the registered substance,
Reaction mass of N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide, would share a similar toxicity profile and would also not be predicted to be a skin sensitiser.
Respiratory sensitisation:
There are no data available to classify Reaction mass of N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide as a sensitizer to respiratory system.
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.