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EC number: 442-600-9 | 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
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: Well-documented GLP study, performed in accordance with the OECD Guideline 406 (Skin Sensitisation).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Remarks:
- Two deviations: purity & stability not determined; achieved concentration not determined by analysis
- Type of study:
- Buehler test
Test material
- Reference substance name:
- -
- EC Number:
- 442-600-9
- EC Name:
- -
- Molecular formula:
- The substance is a UVCB for which it is not possible to provide a molecular formula
- IUPAC Name:
- (9E)-N-[(N'-hexadecanoyloctadecanehydrazido)methanimidoyl]octadec-9-enamide
- Details on test material:
- Description: Complex reaction product of an aminate base-carbonate and fatty acids
Chemical name: HiTEC 7134 Performance additive
- Physical state: viscous liquid
- Storage condition of test material: ambient temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall, Newchurch, Burton-on-Trent, Staffs, UK
- Age at study initiation: young adults
- Weight at study initiation: 342-445 g
- Housing: five animals/cage
- Diet: ad libitum, FD1, Special Diet Services, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction phase: 0.4 ml of 15% w/v preparation in corn oil
Challenge phase: 0.1-0.2 ml of 5% w/v preparation in corn oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction phase: 0.4 ml of 15% w/v preparation in corn oil
Challenge phase: 0.1-0.2 ml of 5% w/v preparation in corn oil
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS
Undiluted test substance and 75%, 50% and 25% w/v preparations of the test substance in corn oil were applied to the skin of two female guinea pigs. Irritation was detected in all concentrations. Further dose levels (15%, 10%, 5% and 3%) were tested. Slight irritation signs were observed at 15% and 10%, while no signs of irritation were seen after application of the two lowest doses. The 15% dose was selected as appropriate for the induction phase and the 5% for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: an area on the scapular region was clipped free of hair and a substance was applied through a lint patch; the patch was covered with an occlusie dressing
- Control group: similar to the test groups the same patch was used but soaked only in corn oil
- Site: scapular region 5X5 cm
- Frequency of applications: every 7 days
- Concentrations: 0.4 ml of 15% w/v preparation in corn oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 6 h
- Test groups: an area on the left flank was clipped free of hair, and a lint patch with the test substance was applied. An occlusive dressing was used
- Control group: treated identically to the test groups
- Site: 5X15 cm
- Concentrations: 0.1-0.2 ml of 5% w/v preparation in corn oil
- Evaluation (hr after removal of the dressings): 1 to 2 days - Challenge controls:
- NA
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldhyde
Study design: in vivo (LLNA)
- Concentration:
- NA
- No. of animals per dose:
- NA
- Details on study design:
- NA
- Statistics:
- NA
Results and discussion
- Positive control results:
- Scattered mild redness or moderate and diffuse redness was seen in 17/20 tested animals (net sensitising response of 65%).
In vivo (non-LLNA)
Resultsopen allclose all
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Hours after challenge:
- 24
- Dose level:
- 10% w/v
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- (control group)
- Remarks on result:
- other: . Hours after challenge: 24.0. Dose level: 10% w/v. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: (control group).
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% w/v
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 3% w/v. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Hours after challenge:
- 24
- Dose level:
- 3% w/v
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- (control group)
- Remarks on result:
- other: . Hours after challenge: 24.0. Dose level: 3% w/v. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: (control group).
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3% w/v
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 0.3% w/v. No with. + reactions: 18.0. Total no. in groups: 20.0.
- Hours after challenge:
- 24
- Dose level:
- 0.3% w/v
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- (control group)
- Remarks on result:
- other: . Hours after challenge: 24.0. Dose level: 0.3% w/v. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: (control group).
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% w/v
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% w/v. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Hours after challenge:
- 24
- Dose level:
- 0.1% w/v
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- (control group)
- Remarks on result:
- other: . Hours after challenge: 24.0. Dose level: 0.1% w/v. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: (control group).
Any other information on results incl. tables
Table 1: Challenge responses
Animal No |
Sex |
24 h |
48 h |
|
Animal No |
Sex |
24 h |
48 h |
237 |
F |
1 |
0 |
|
252 |
F |
0 |
0 |
238 |
F |
1 |
1 |
|
253 |
F |
0 |
0 |
239 |
F |
0 |
0 |
|
254 |
F |
0 |
0 |
240 |
F |
0 |
0 |
|
255 |
F |
0 |
0 |
241 |
F |
0 |
0 |
|
256 |
F |
1 |
1 |
242 |
F |
0 |
0 |
|
257 |
F |
0 |
0 |
243 |
F |
0 |
0 |
|
258 |
F |
0 |
0 |
244 |
F |
1 |
1 |
|
259 |
F |
0 |
0 |
245 |
F |
0 |
0 |
|
260 |
F |
0 |
0 |
246 |
F |
1 |
1 |
|
261 |
F |
0 |
0 |
247 |
F |
1 |
1 |
|
262 |
F |
0 |
0 |
248 |
F |
0 |
0 |
|
263 |
F |
0 |
0 |
249 |
F |
1 |
0 |
|
264 |
F |
0 |
0 |
250 |
F |
1 |
1 |
|
265 |
F |
0 |
0 |
251 |
F |
0 |
0 |
|
266 |
F |
0 |
0 |
257 -266: control group
237 -256: test group
Scale
0- No reaction
1- Scattered mild redness
2- Moderate and diffuse redness
3- Intense redness and swelling
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- HiTEC 7134 was tested for its skin sensitisation potential on guine pigs in accordance with the Buehler test. The results revealed that the test material shall be considered as a skin sensitiser under the specific test conditions.
- Executive summary:
The sensitisation potential of HiTEC 7134 was assessed using a method based on that described by Ritz and Buehler (1980). The test substance in corn oil was applied dermally to 20 female Dunkin-Hartley guinea pigs. Ten animals were used as controls. The study involved an initial induction phase and a sequential challenge phase. Concentrations applied topically during the two phases were as follows: 0.4 ml of 15% w/v preparation in corn oil during induction, and 0.1-0.2 ml of 5% w/v preparation in corn oil during the challenge phase. The sensitisation response of the animals was determined 1 and 2 days after challenge by assessing the degree of erythrema. The study was performed in accordance with the OECD Guideline 406 (Skin Sensitisation). The challenge of the previously-induced animals with H7134 exerted a moderate skin sensitisation response in eight out of the 20 animals, expressed as scattered mild redness. Such effects were not seen in any of the control animals. The net response was 40% and based on the classification criteria H7134 shall be classified as a skin sensitizer.
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