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EC number: - | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 November 2017 to11 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Octadecanoic acid, reaction products with tetraethylenepentamine
- Cas Number:
- 71799-54-7
- Molecular formula:
- Not applicable - UVCB substance
- IUPAC Name:
- Octadecanoic acid, reaction products with tetraethylenepentamine
- Test material form:
- solid
- Details on test material:
- - Appearance: Amber solid
- Storage: Room temperature (20 ± 5 °C); protected from light.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 200-230 g
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 2-3 animals per cage in a room equipped with central air conditioning.
- Diet: The laboratory food was offered at recommended doses each day approximately at the same time.
- Water: Ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 23.28 ± 0.18 °C
- Humidity: 53.36 ± 1.9 %
- Photoperiod: 12-hour light /12-hour dark cycle
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by clipping and shaving.
- % coverage: approximately 10 % of the total body surface area
- Type of wrap if used: Test material was held in contact with the skin by using semi-occlusive dressing with non-irritating tape throughout the 24-hours exposure period.
REMOVAL OF TEST SUBSTANCE
- At the end of the exposure period (24 hours), any residuals of the test material were removed by using lukewarm water without altering the existing response or integrity of the epidermis.
TEST MATERIAL
- A limit dose of 2000 mg/kg body weight was used as a starting dose. One female was dosed. Test material-related mortality was not observed during 48-hours exposure period. The sighting study was finished; the main test was started with dose of 2000 mg/kg body weight. The additional 2 females were dosed in the Main Study with the dose of 2000 mg/kg body weight.
- Preparation: The required amount of the test material (according to the body weight and dose) was mixed with the vehicle (olive oil) shortly before application according to the actual body weight.
VEHICLE
- Lot/batch no.: L63417
- Olive oil is a standard vehicle according to OECD TG 402 - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Animals were observed individually immediately after the application of the test material and then 0.5, 1, 2, 4 and 6 hours later. Each animal was inspected daily for the next 14 days. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test material using the Draize criteria.
- Individual weights of animals were determined shortly before the test material was applied and weekly thereafter. Weight differences after first and second week after application were calculated and recorded.
- Necropsy of survivors performed: Yes, all test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.
Results and discussion
- Preliminary study:
- One female was dosed. Test material-related mortality was not observed during 48 hours.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative skin reactions were registered.
- Gross pathology:
- All animals were necropsied. During necropsy, no macroscopic changes were noticed.
Any other information on results incl. tables
Table 1: Body Weight
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 – Week 1 |
|
1 |
200 |
210 |
215 |
10 |
15 |
5 |
2 |
230 |
230 |
230 |
0 |
0 |
0 |
3 |
225 |
230 |
230 |
5 |
5 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, the LD50 of the test material is greater than 2000 mg/kg bodyweight.
- Executive summary:
The acute dermal toxicity of the test material was determined in accordance with the standardised guideline OECD 402, under GLP conditions.
The test material was applied as a single dermal dose to Wistar rats. A limit dose of 2000 mg/kg body weight was used as the starting dose. One female was dosed. Test material-related mortality was not observed during 48 hours. A total of three female rats were dosed with a limit dose of 2000 mg/kg body weight.
The test material applied to 3 females at a limit dose of 2000 mg/kg body weight did not cause death. The body weight of 2/3 females increased during the study, stagnation of body weight in one female was noticed. No signs of toxicity were observed at the dosage of 2000 mg/kg body weight during the first 4 hours or 14-day observation period. No dermal changes were observed. During necropsy no macroscopic findings were noticed.
Under the conditions of this study, the LD50 of the test material is greater than 2000 mg/kg bodyweight.
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