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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 404 (1992; Acute dermal irritation/corrosion)
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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- purity and stability of the substance not reported
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
- Physical state: viscous liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, UK
- Age at study initiation: young adults
- Weight at study initiation: 3730-4450 g
- Housing: individually in cages
- Diet: ad libitum, STANRAB SQC, Special Diet Services Limited, Stepfield, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: removal of hair with veterinary clippers
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 28 days
- Number of animals:
- 2 male and one female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5*2.5 cm
- % coverage: 100
- Type of wrap if used: 4-ply surgical gauze, secured by surgical tape; impermeable rubber sheeting was wrapped around the trunk of the animals
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was removed with swabs of absorbent cotton wool soaked in warm water
- Time after start of exposure: 4 h
SCORING SYSTEM: The Draize scale (1959) was used to assess the degree of erythrema and oedema at the application sites approximately 1 h and 1, 2 and 3 days after removal of the cover and then at intervals for up to 28 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: mean of 1, 2 and 3 days after decontamination
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: mean of 1, 2 and 3 days after decontamination
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: mean of 1, 2 and 3 days after decontamination
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: mean of 1, 2 and 3 days after decontamination
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: mean of 1, 2 and 3 days after decontamination
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: mean of 1, 2 and 3 days after decontamination
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight, well-defined or moderate to severe erythrema was seen in two of the animals for 7 days and in one for 21 days after the application of the substance. Very slight, slight or moderate edema was observed in two animals for 4 days after application. Other signs of skin irritation included desquamation, thickening, wrinkling, scabbing, bruising and areas with newly formed skin. Most of the symptoms persisted till the end of the 14 days (in at least 2 of the three animals tested) but disappeared 28 days post-exposure.
- Other effects:
- No other sings of toxicity were detected in the animals during the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- H7134 was tested for its skin irritation potential New Zeland rabbits. Under these test conditions the test material was a moderate skin irritant.
- Executive summary:
Three New Zeland white albino rabbits were tested for skin irritation with HiTEC 7134, after a single 4h application of 0.5 ml. The animals were observed for up to 28 days for any sings of skin irritation. Very slight, well-defined or moderate to severe erythrema was seen in two out of the three animals for 7 days and one animal for 21 days post-application. Very slight, slight or moderate edema was observed in two animals up to 4 days after application. Additional signs of irritation such as desquamation, thickening, wrinkling, scabbing, bruising and areas of new skin were recorded during the conduction of this experiment. Based on these results the test substance may be considered as a moderate skin irritant to the rabbit.
Despite the fact that , the mean scores obtained for erythrema and edema for two out opf the three animals, are below 2.3 (limit for classification according to Regulation 1272/2008), the substance shall be classified as a skin irritant, due to persistence of inflammatory symptoms (like desquamation) over the 14 day initial obsevation period.
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