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EC number: 604-608-2 | CAS number: 147853-32-5
- 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
Endpoint summary
Administrative data
Description of key information
Oral: LD50 (rat) > 2000 mg/kg bw (experimental value), ≥ 5000 mg/kg bw (LD50 cut-off) (OECD 423, GLP)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Jan – 17 Feb 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP – Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sprague-Dawley CD (Crl:CD® (SD) IGS BR)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 193 – 216 g
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: animals were housed in groups of 3 per cage in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: certified Rat and Mouse Diet (Code 5LF2; BCM IPS Limited, London, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Example: 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: arachis oil BP
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the test material did not dissolve/suspend in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The author stated that using all available information on the toxicity of the test material, 2000 mg/kg bw was chosen as the starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females (3 per testing step)
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 30 min, 1, 2 and 4 h after dosing and subsequently daily for 14 days and individual body weights were determined prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, body weight - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: experimental result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off according to OECD 423
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy revealed no substance-related findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Table 1. Individual body weights and body weight changes.
Dose Level |
Animal Number |
Body weight (g) |
Body weight Gain (g) |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Female |
201 |
247 |
263 |
46 |
16 |
1-1 Female |
210 |
268 |
306 |
58 |
38 |
|
1-2 Female |
216 |
253 |
272 |
37 |
19 |
|
2-0 Female |
206 |
258 |
276 |
52 |
18 |
|
2-1 Female |
200 |
240 |
260 |
40 |
20 |
|
2-2 Female |
193 |
243 |
259 |
50 |
16 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5.1, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: oral
The acute oral toxicity of Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated was assessed in rats in a study conducted according to OECD guideline 423 and under GLP conditions (Sanders, 2004). Two groups of 3 female rats each were sequentially treated with the test material (diluted in arachis oil BP) at a dose level of 2000 mg/kg bw by oral gavage. No mortality occurred, no clinical signs of toxicity and no effects on body weight gain were observed up to the end of the 14-day observation period. No abnormalities were noted at necropsy.
Based on the study results, the experimentally determined oral LD50 in rats is greater than 2000 mg/kg bw.
Due to the lack of moribund or dead animals at both testing steps and according to Annex 2d of OECD guideline 423, the oral LD50 value can be considered to be equal or greater than 5000 mg/kg bw.
Acute toxicity: inhalation
This information is not available.
The substance Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated is a viscous liquid with a very low vapour pressure. Due to its physiochemical properties, exposure of humans via inhalation is unlikely.
Acute toxicity: dermal
This information is not available.
The physicochemical properties of the substance (water solubility: < 0.1 mg/L; log Kow: > 6.5) and molecular weight (> 500 g/mol) are in a range which anticipate a low to very low dermal absorption. This assumption is supported by the available toxicological data involving dermal exposure: the substance is neither skin irritating nor skin sensitising, and no signs of systemic toxicity were observed in the corresponding studies. Thus, the physicochemical and toxicological properties of the substance do not suggest potential for a significant rate of absorption through the skin.
Furthermore, based on all the available data no human health hazard is identified resulting in classification and labelling of the substance. Thus, the substance is not toxic after acute oral exposure, not mutagenic or clastogenic in vitro and (based on read-across) not toxic after repeated oral exposure and not toxic to reproduction.
Taken together, there is sufficient weight of evidence available leading to the assumption/conclusion that the substance is not toxic after acute dermal exposure.
Conclusions for acute toxicity
The substance Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated has been tested for acute oral toxicity in rats. No mortality and no signs of systemic toxicity were observed. The experimentally determined oral LD50 was greater than 2000 mg/kg bw. According to the applied test method (OECD Guideline 423), the oral LD50 can be considered to be ≥ 5000 mg/kg bw.
Based on the available data, the substance is considered to be not toxic by the oral route.
There are no studies available on the acute toxicity by the dermal and inhalation routes. The high molecular weight and physicochemical properties of the substance (viscous liquid of very low vapour pressure, low water solubility and high lipophilicity) indicate that human exposure by inhalation is unlikely and do not suggest potential for a significant rate of absorption through the skin.
Justification for selection of acute toxicity – oral endpoint
There is only one study available.
Justification for classification or non-classification
The available data on the acute oral toxicity of Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
Data are lacking for acute toxicity by the inhalation and dermal routes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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