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EC number: 279-510-2 | CAS number: 80584-99-2
- 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:
- 2016-07-21 to 2016-10-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, linseed-oil, reaction products with 2-amino-2-(hydroxymethyl)-1,3-propanediol and formaldehyde
- EC Number:
- 279-510-2
- EC Name:
- Fatty acids, linseed-oil, reaction products with 2-amino-2-(hydroxymethyl)-1,3-propanediol and formaldehyde
- Cas Number:
- 80584-99-2
- Molecular formula:
- n.a.
- IUPAC Name:
- Fatty acids, linseed-oil, reaction products with 2-amino-2-(hydroxymethyl)-1,3-propanediol and formaldehyde
- Test material form:
- liquid
- Details on test material:
- - Batch No: 3300081
- Physical state: liquid
- Colour: colourless to yellow
- Purity: 100 %
- Expiry date: 2018-05-16
- Storage conditions: Room temperature (20 ± 5 °C), keep away from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Velaz Prague, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 185-200g
- Fasting period before study: food was withheld over-night (but not water).
- Housing: plastic cages suspended on stainless steel racks, up to 3 animals per cage.
- Diet (e.g. ad libitum): laboratory food ssniff (Spezialdiäten GmbH, Germany), in recommended doses each day approximately at the same time.
- Water (e.g. ad libitum): tap water for human consumption (unlimited), quality of drinking water is periodical analysed.
- Acclimation period: 5 days prior to the start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 ± 0.4 °C
- Humidity (%): 55.3 ± 4.0%
- Air changes (per hr): central air conditioning
- Photoperiod (hrs dark / hrs light): 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. (if required): L52897, Expiry Date: 04/2017
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Available information indicated that the test item is likely to be nontoxic with regard to acute toxicity. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 females per step, 2 steps performed
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observation was made immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Thereafter, the animals were observed for clinical signs daily. Weighing was performed shortly before administration of the test item and weekly thereafter.
- Necropsy of survivors performed: yes, all test animals were subjected to gross necropsy. Full, detailed gross necropsy included examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents.
- Other examinations performed: Clinical observations included changes in skin, fur, eyes and mucous membranes, 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. - Statistics:
- N.A.
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: No change of health and no negative reactions were registered. Animals lived through observation period without signs of intoxication.
- Gross pathology:
- No macroscopically findings were noticed, during necropsy.
- Other findings:
- N.A.
Any other information on results incl. tables
Table 1: Body Weight
Sex |
Dose |
ID |
Body Weight(g) |
Body Weight Difference (g) |
||||
Initial |
Week1 |
Week2 |
Week 1 -Initial |
Week 2 -Initial |
Week 2 - Week1 |
|||
♀ |
2000 mg/kg |
1 |
200 |
220 |
225 |
20 |
25 |
5 |
2 |
190 |
220 |
230 |
30 |
40 |
10 |
||
3 |
195 |
220 |
235 |
25 |
40 |
15 |
||
4 |
190 |
220 |
250 |
30 |
60 |
30 |
||
5 |
185 |
230 |
235 |
45 |
50 |
5 |
||
6 |
185 |
200 |
230 |
15 |
45 |
30 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats according to OECD 423, no adverse effects were observed for the test item VOELOFA Monomer at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is determined to be greater than 2000 mg/kg bw.
- Executive summary:
In an acute ora ltoxicity study (acute toxic class method, OECD 423), two groups of fasted, 8-12 weeks old female Wistar rats (3 rats/ group) were given a single oral dose of VOELOFA Monomer (100% purity) in olive oil at the limit dose of 2000 mg/kg bw and were observed for 14 days.
Oral LD50Females = > 2000 mg/kg bw
No mortality was observed during the study. Animals lived through observation period without signs of intoxication. Throughout the 14-day observation period, no body weight losses were observed. At necropsy, no macroscopically findings were noticed. Based on the results from this study, the oral LD50 in rats is considered to be greater than 2000 mg/kg bw.
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