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EC number: 604-580-1 | CAS number: 147256-33-5
- 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 (EU Method B.1), rat: LD50 > 2000 mg/kg bw
Inhalation (OECD 403), rat: LC50 > 5.3 mg/L air (based on read-across from CAS 68334-05-4)
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:
- 24 Jul - 16 Aug 2012
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (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
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar (RccHanTM:WIST)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 146-166 g (first group) and 157-163 g (second group)
- Fasting period before study: animals were fasted overnight immediately before the day of dosing and for approx. 3 to 4 h after dosing.
- Housing: animals were housed in groups of 3 in suspended solid-floor polypropylene cages furnished with woodflakes and environmental enrichment items.
- Diet: 2014C Teklad Global Diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 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:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.18 mL/kg
CLASS METHOD
- Rationale for the selection of the starting dose: based on available information on the toxicity of the test item, 2000 mg/kg bw was chosen as the starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortalities and overt signs of toxicity 30 min, 1, 2 and 4 h after dosing and subsequently once daily during the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 experimental
- Sex:
- male/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 mortalities were observed during the study period.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the 14-day observation period.
- Gross pathology:
- At gross pathology, no abnormalities were found.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 1) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 23 Apr - 07 May 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Version / remarks:
- adopted in 2009
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 12 weeks
- Mean weight at study initiation: 349 g (males); 229 g (females)
- Housing: before exposure: Group housing of five animals per sex per cage in labelled Makrolon cages (type IV; height 18 cm) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom); after exposure: Group housing of maximally three animals per sex per cage as described above, except that a paper sheet was introduced into the cage covering the bedding and cage enrichment to prevent suffocation in case of bad health condition. At the end of the day of exposure the paper sheet was removed.
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany, ad libitum except during exposure to the test substance.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual range: 19.8 – 21.4)
- Humidity (%): 40-70 (actual range: 37 - 60)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The design of the exposure chamber is based on the flow past nose-only inhalation chamber (Am. Ind. Hyg Assoc. J. 44(12): 923-928, 1983).
- Method of holding animals in test chamber: animal ports
- System of generating particulates/aerosols: An aerosol was generated by nebulization of the test substance by means of a nebulizer (type 950, Hospitak Inc., Lindenhurst, NY, USA)
- Method of particle size determination: Amounts of test substance collected were measured gravimetrically. Subsequently the Mass Median Aerodynamic Diameter (MMAD) and the Geometric Standard Deviation (GSD) were determined
- Treatment of exhaust air: From the exposure chamber the test atmosphere was passed through a filter before it was released to the exhaust of the fume hood.
TEST ATMOSPHERE
- Brief description of analytical method used: Samples were drawn through a glass fiber filter (type APFC04700, Millipore, Billerica, MA, USA). The collected amount of test substance in the air sample was measured gravimetrically. Sample volumes were measured by means of a dry gas meter (type G 1.6, Actaris Meterfabriek B.V., Dordrecht, The Netherlands).
- Samples taken from breathing zone: yes
VEHICLE
- Concentration of test material in vehicle: Since the substance was too viscous to be aerosolized, an acetone : test substance formulation (1 : 3 v/v) was prepared.
- Justification of choice of vehicle: Acetone (Acetone p.a.: Merck, Darmstadt) was selected as suitable vehicle based on trial formulation results.
TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The Mass Median Aerodynamic Diameter (MMAD) and geometric standard deviation (GSD) were determined twice. The MMAD was 3.0 µm and 3.3 µm respectively and the GSD was 1.9 and 2.0 respectively.
CLASS METHOD
- Rationale for the selection of the starting concentration: The target concentration was based on the hazard categories for dust and mists specified in the Globally Harmonized System of Classification of Chemicals (GHS), United Nations, New York and Geneva, 2003. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetrically
- Duration of exposure:
- 4 h
- Concentrations:
- 9 mg/L (nominal concentration)
5.3 ± 0.5 mg/L (mean actual concentration)
The concentration was stable. The generation efficiency (ratio of actual and nominal concentration) was 59%. - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability: Twice daily; Clinical signs during exposure: Three times during exposure for mortality, behavioural signs of distress and effects on respiration. Clinical signs after exposure: Twice (at 1 and at 3 hours after exposure) on the day of dosing (day 1) and once daily thereafter, until day 15. Body weights Days 1 (pre-administration), 2, 4, 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was performed (the method used was not intended to calculate a LC50 value).
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.3 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the observation period.
- Body weight:
- Body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study.
- Gross pathology:
- Necropsy and histopathological examination 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
The inhalatory 4-h LC50value of Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters in Wistar rats was established to exceed 5 mg/L.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate, reliable study (Klimisch score 2 due to read-across) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on similar functional groups and similar precursors/breakdown products (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are no data available for the acute inhalation toxicity of Fatty acids C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5). In order to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Overview of acute toxicity:
CAS |
147256-33-5 (a) |
68334-05-4 (b) |
Chemical Name |
Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane |
Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (ESIS: NLP) |
MW |
624.97 |
673.10 |
Acute toxicity oral |
Experimental result: |
-- |
Acute toxicity inhalation |
RA: CAS 68334-05-4 |
LC50 > 5.3 mg/L air |
Acute toxicity dermal |
Waiving |
-- |
(a) Substances subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.
(b) Substances that are either already registered under REACh or not subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.
The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Acute toxicity
Oral
CAS 147256-33-5
The acute toxicity via the oral route of Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane has been investigated in two studies in rats (CAS 147256-33-5).
A GLP-conform acute oral toxicity study with Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane was performed in female Wistar (RccHanTM:WIST) rats according to the acute toxic class method described in OECD guideline 423 (Sanders, 2012). In two sequential steps, the undiluted test substance was administered to the each 3 animals at a dose level of 2000 mg/kg bw (limit test) via oral gavage. In both treatment steps, no mortalities and no clinical signs of toxicity were observed up to the end of the 14-day study period. All animals showed the expected gains in body weight and no abnormalities were observed at necropsy. Based on these results, the experimental oral LD50 in rats was greater than 2000 mg/kg bw. According to OECD guideline 423, an oral LD50 cut-off greater than 5000 mg/kg bw was derived.
In a further study, the acute oral toxicity of Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane was investigated in Wistar rats according to EU Method B.1 and in compliance with GLP (Potokar, 1989). The test substance in vehicle (arachis oil) was administered by oral gavage to groups of 5 animals per sex at a limit dose of 2000 mg/kg bw. No mortalities and no clinical signs were observed up to the end of the 14-day observation period. Body weights were not affected by treatment with the test substance. Gross pathology revealed a filled bladder in 2 males and hydrometra (left) in 1 female. However, these findings were not related to treatment. Based on the results, the oral LD50 value for male and female rats was greater than 2000 mg/kg bw.
In summary, the oral LD50 of Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane was greater than 2000 mg/kg bw.
Inhalation
CAS 68334-05-4
The acute inhalation toxicity of Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters was investigated in a GLP-compliant study according to the acute toxic class method described in OECD guideline 436 (Huygevoort, 2010). One group of 3 Crl:WI(Han) rats per sex were exposed to an analytical atmosphere concentration of the test aerosol of 5.3 mg/L air (5300 mg/m³) for 4 h using a nose only exposure system. No mortality and no clinical signs of toxicity were observed up to the end of the 14-day observation period. The body weight gain in males and females was within the range expected for rats of this strain. Gross pathology and histopathological examination did not reveal any substance-related changes.
Based on these results, the LC50 value for Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters was assumed to be greater than 5.3 mg/L air (5300 mg/m³).
Dermal
This information is not available.
According to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5.3, Column 2, testing by the dermal route is appropriate if: the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. Overall, the calculated low dermal absorption potential, the low water solubility, the molecular weight (>100), and the fact that the substance is not irritating to skin implies that dermal uptake of Fatty acids, C18 unsatd., dimers, mixed esters with oleic acid and trimethylolpropane in humans is considered as very limited. Studies on the acute oral and inhalation toxicity are available. With respect to the animal welfare, the conduct of an acute dermal toxicity study would be scientifically unjustified.
Conclusion for acute toxicity
In summary, two studies are available addressing the acute oral toxicity of Fatty acids C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) resulting in an oral LD50 > 2000 mg/kg bw. For acute inhalation toxicity, one study is available with the analogue substance Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4), showing an LC50 value greater than 5.3 mg/L air. Taking into account the MW (above 500), the high log Pow value (>5.7) and the poor water solubility (< 1 mg/L) dermal absorption rate is expected to be very low, thus acute dermal toxicity is not anticipated.
Therefore, the available data indicate no hazard for acute oral, dermal and inhalation toxicity of Fatty acids C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane.
Justification for classification or non-classification
Based on the results of the target and structurally similar substances, the available data on acute oral, inhalation and dermal toxicity 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.
There are no data available on acute dermal toxicity.
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