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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-661-5 | CAS number: 109-28-4
- 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: Study conducted in accordance with OECD guideline 406 and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2007
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
- Justification for non-LLNA method:
- A guideline and GLP-compliant guinea pig maximisation test was available from a time before the LLNA-OECD-TG was adopted. The information is sufficient to evaluate the sensitising potential of the test substance. Hence, a LLNA was not conducted.
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]oleamide
- EC Number:
- 203-661-5
- EC Name:
- N-[3-(dimethylamino)propyl]oleamide
- Cas Number:
- 109-28-4
- Molecular formula:
- C23H46N2O
- IUPAC Name:
- (9Z)-N-[3-(dimethylamino)propyl]octadec-9-enamide
- Test material form:
- other: liquid
- Details on test material:
- Color: yellow
Batch: R401/57
Purity: 89% (acid number)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Supplier: Charles River (F-69592 L'Arbresle)
Weights at beginning of study: 264-306 g
Age at beginning of study: 4 weeks
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: 0.3906% (intradermic injection), 100% (topical application)
Challenge: 1.5625% and 0.7813%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: 0.3906% (intradermic injection), 100% (topical application)
Challenge: 1.5625% and 0.7813%
- No. of animals per dose:
- Negative control group: 5 animals
Treated group: 11 animals - Details on study design:
- PRELIMINARY STUDIES:
3 preliminary studies were conducted to determine the maximal non necrotizing concentration (MNNC) by intradermal injection, the pre-maximal non irritant concentration (Pre-MNIC) by topical application, and the maximal non irritant concentration (MNIC) by topical application, respectively.
To determine the MNNC, two animals received on both sides of the spine, a volume of 0.1 ml of the test item at 6 concentrations: 100%, 50%, 25%, 12.5%, 6.25% and 3.125% in olive oil. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours later and 48 hours later
if necessary. Due to the necrosis registered at these 6 concentrations, the two animals received on both sides of the spine, a volume of 0.1 ml of the test item, at 4 concentrations: 1.5625%, 0.7813%, 0.3906% and 0.1953% in olive oil. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours later and 48 hours later if necessary.
To determine the Pre-MNIC, the test item was applied on the dorso-lumbar zone of two guinea pigs shorn beforehand, with occlusive dressing for 24 hours, at 4 different concentrations: 100%, 50%, 25% and 12.5% in liquid paraffin. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after removal of the dressing.
Finally, for determining the MNIC, three guinea pigs were treated according to the negative control group for the induction phase (i.e. olive oil and liquid paraffin). During the challenge phase, the animals were treated with the test item placed onto the selected treatment sites and covered with an occlusive dressing for a period of 24 hours at 4 different concentrations: 6.25%, 3.125%, 1.56% and 0.78% in liquid paraffin. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after removal of the occlusive dressing.
MAIN STUDY:
A. INDUCTION PHASE:
Number of exposures: 2 (intradermal on day 0 and topical on day 6)
Negative control group: received 3 pairs of intradermal injection (ID) of 0.1 ml (one injection of each pair placed on either side of the spine): 2 ID containing Freund’s Complete Adjuvant diluted at 50 % in isotonic sodium chloride, 2 ID containing olive oil, and 2 ID containing a mixture with equal volumes v/v of Freund’s Complete Adjuvant at 50% and isotonic sodium chloride
Treated group: received 3 pairs of intradermal injection (ID) of 0.1 ml (one injection of each pair placed on either side of the spine): 2 ID: containing Freund’s Complete Adjuvant diluted by 50 % in isotonic sodium chloride, 2 ID containing test item at 0.3906%, and 2 ID a test mixture in equal volumes v/v Freund’s Complete Adjuvant at 50% and the test item at 0.7813%.
On day 6 of the study, the scapular zone of all animals in each group was shorn, followed by topical application under occlusive dressing for 48 hours on the injection sites: 0.5 ml of liquid paraffin (negative control) and 0.5 ml of the test item at 100% (treated group), respectively.
B. CHALLENGE PHASE
On day 20 of the study, the animals of both groups were treated as follows: 1 sample cup containing the test item at 1.56% (MNIC) and at 0.78% (1/2 MNIC) was applied to the previously shorn dorso-lumbar zone on either side of the spine for 24 hours under occlusive dressing. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.56%
- No. with + reactions:
- 11
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.56%. No with. + reactions: 11.0. Total no. in groups: 11.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.781%
- No. with + reactions:
- 11
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.781%. No with. + reactions: 11.0. Total no. in groups: 11.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.56%
- No. with + reactions:
- 11
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.56%. No with. + reactions: 11.0. Total no. in groups: 11.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.781%
- No. with + reactions:
- 11
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.781%. No with. + reactions: 11.0. Total no. in groups: 11.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1.56%
- No. with + reactions:
- 3
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1.56%. No with. + reactions: 3.0. Total no. in groups: 11.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.781%
- No. with + reactions:
- 1
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.781%. No with. + reactions: 1.0. Total no. in groups: 11.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.56%
- 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: 1.56%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.781%
- 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: 0.781%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.56%
- 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: 1.56%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.781%
- 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: 0.781%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1.56%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1.56%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.781%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.781%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It can be concluded that under the experimental conditions chosen, the test item Trennmittel ZM 121 caused skin sensitisation in the guinea pig maximization test. Based on the results of the study, the test substance needs to be classified as a category 1A skin sensitiser (H317 - May cause allergic skin reactions) according to Regulation (EC) No 1272/2008 (CLP).
- Executive summary:
The test substance Trennmittel ZM 121 was tested for a possible allergenic activity after intradermic injection and topical administration in guinea pigs. The study was conducted according to OECD guideline 406. After induction (intradermic injection at 0.3906% and topical application at 100%) of 11 animals and a 10-day rest phase, the animals were challenged by a single topical application of the test item diluted at 1.5625% and 0.7813% in liquid paraffin under occlusive dressing for 24 hours. After the challenge phase, a moderate erythema associated with a slight to moderate oedema was detected at the skin area treated with 1.5625% in all animals. A significant macroscopical cutaneous reaction at this application site was still registered in 100% and 27% of the animals 48 and 72 hours after the challenge phase, respectively. At the sites treated with 0.7813%, a slight to moderate erythema, in part associated with a slight to moderate oedema, was detected in all animals 24 hours after the challenge phase. A significant macroscopical cutaneous reaction was still registered in 100% (11/11) and 9% (1/11) of the animals at this application site 48 and 72 hours after the challenge phase, respectively. No cutaneous intolerance reaction was recorded in animals from the negative control group.
It can be concluded that under the experimental conditions chosen, the test item Trennmittel ZM 121 caused skin sensitisation in the guinea pig maximization test. Based on the results of the study, the test substance needs to be classified as a category 1A skin sensitiser (H317 - May cause allergic skin reactions) according to Regulation (EC) No 1272/2008 (CLP).
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.