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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 November 2017 to 28 November 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- 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: 160-195 g
- Fasting period before study: Food but not water was withheld over-night prior to dosing and for 3 to 4 hours after dosing.
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 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: 23.26 ± 0.16 °C
- Humidity: 53.35 ± 1.86 %
- Photoperiod: 12-hour light /12-hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD TG 423
- Lot/batch no.: L63417
MAXIMUM DOSE VOLUME APPLIED:
- The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test material-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose.
- The required amount of the test material (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Animals were observed individually immediately after administration of the test material and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days. Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Individual weights of animals were measured immediately prior to administration of the test material and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.
- Necropsy of survivors performed: Yes, all test animals were subjected to gross necropsy and the results were recorded for each animal. - Statistics:
- No statistical analysis was done in conjunction with this study.
Results and discussion
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: - Piloerection was observed in animals No 3, 4 and No 5. The symptom started to appear 4 hours post-treatment and it persisted next two days. It reappeared from 10th day and it lasted until the end of the study. - Dyspnoea was observed from the first pos
- Gross pathology:
- All animals were necropsied. Increased amount of gas in gastrointestinal tract, microsplenia and atrophy of thymus were registered in animals No. 3, 4 and 5.
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 |
190 |
195 |
200 |
5 |
10 |
5 |
2 |
185 |
200 |
210 |
15 |
25 |
10 |
3 |
195 |
210 |
160 |
15 |
-35 |
-50 |
4 |
160 |
165 |
115 |
5 |
-45 |
-50 |
5 |
175 |
180 |
140 |
5 |
-35 |
-40 |
6 |
175 |
200 |
200 |
25 |
25 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of the study, the acute oral LD50 of the test material in the female Wistar strain rat is greater than 2000 mg/kg body weight.
- Executive summary:
The acute oral toxicity of the test material was investigated in accordance with the standardised guideline OECD 423, under GLP conditions.
The test material was administered as a single oral dose to female Wistar rats, the Acute Toxic Class (ATC) method was used. A limit dose of 2000 mg/kg body weight was used as a starting dose.
The test material administered to 6 females at a limit dose did not cause death. Piloerection and dyspnoea were observed during the observation period. A decrease of body weights in 3/6 animals and stagnation of body weight in one animal were observed between the first and second week after administration of the test item. During necropsy, increased amount of gas in gastrointestinal tract, microsplenia and atrophy of thymus were registered.
Under the conditions of the study, the acute oral LD50 of the test material in the female Wistar strain rat is greater than 2000 mg/kg body weight.
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