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EC number: 605-694-4 | CAS number: 173832-46-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin irritation (OECD 404): not irritating (based on read-across from CAS 68334-05-4)
Eye irritation (OECD 405) not irritating (based on read-across from CAS 68334-05-4)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 13 Apr - 30 Apr 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Belton, Leics, England
- Age at study initiation: 7-14 weeks
- Weight at study initiation: 1602 - 2455 g
- Housing: Animals were individually housed in labelled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet: Pelleted, Global Diet 2030 (Harlan Teklad®, Mucedola, Milanese, Italy), approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual range: 18.6 – 19.3)
- Humidity (%): 40-70 (actual range: 43 - 73)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 hours after the removal of the dressings and test substance. - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the skin
- Type of wrap if used: metalline patch of 2x3 cm mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage (Lohmann GmbH, Neuwied, Germany (Metalline) and 3M, St. Paul, Minnesota, U.S.A. (Micropore and Coban))
REMOVAL OF TEST SUBSTANCE
- Washing: dressing was removed and the skin cleaned of residual test substance using tap water and watery ethanol (50% v/v) (water: Elix, Millipore S.A.S., Molsheim, France; ethanol: Merck, Darmstadt, Germany)
- Time after start of exposure: 4h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: Edema (score = 1) were seen in all animals 1 h after exposure only.
- Irritant / corrosive response data:
- Four hours exposure to 0.5 mL of Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters resulted in very slight erythema (fully reversible within 48 h) and very slight edema (fully reversible within 24 h) in the treated skin areas of the three rabbits. The skin irritation resolved within 48 hours after exposure in all animals. There was no evidence of a corrosive effect on the skin.
- Other effects:
- Sticky remnants of the test substance were present on the skin immediately after removal of the test substance and dry remnants of the test substance were present at the 1 hour observation time point. No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
- Interpretation of results:
- not irritating
- 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 (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 19 Apr - 29 Apr 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Belton, Leics, England
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 1572-1809 g
- Housing: animals were individually housed in labelled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm)
- Diet: pelleted, Global Diet 2030 (Harlan Teklad®, Mucedola, Milanese, Italy), approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual range: 18.6 – 19.3)
- Humidity (%): 40-70 (actual range: 43 - 67)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 hours after instillation of the test substance - Number of animals or in vitro replicates:
- 3 (males)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Instillation of 0.1 mL of Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness and discharge. The irritation completely resolved within 48 hours in all animals.
No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. There was no evidence of ocular corrosion. - Other effects:
- Remnants of the test substance were present on the outside of the eyelids on Day 1. No staining of (peri) ocular tissues by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
- Interpretation of results:
- not irritating
- 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 (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are no data available for the skin irritation/corrosion and eye irritation of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters (CAS 173832-46-7). In order to fulfil the standard information requirements set out in Annex VIII, 8.1 and 8.2, 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 skin and eye irritation:
CAS |
173832-46-7 (a) |
68334-05-4 (b) |
Chemical Name |
Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters |
Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (ESIS: NLP) |
Molecular weight |
973.62 1085.84 1184.02 |
673.10 |
Skin irritation/corrosion |
RA: CAS 68334-05-4 |
Experimental result: |
Eye irritation |
RA: CAS 68334-05-4 |
Experimental result: |
(a) Category members subjected to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.
Lack of data for a given endpoint is indicated by “--“.(b) Surrogate substances are indicated in normal font and are precursors/breakdown products of the target substance (i.e. alcohol and fatty acid moieties). Available data on these substances are used for assessment of toxicological properties by read-across on the same basis of structural similarity and/or mechanistic reasoning as described for the present analogue approach.
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 Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters (CAS 173832-46-7).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
Skin irritation
CAS 68334-05-4
The skin irritation potential of Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters was investigated in a GLP-conform study according to OECD guideline 404 (Stitzinger, 2010). The undiluted test substance (0.5 mL) was applied for 4 h to the clipped skin of 3 male New Zealand White rabbits under semiocclusive conditions. The untreated site of the animals served as control. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing and cleaning of residual test substance using tap water and watery ethanol (50% v/v). Very slight erythema and very slight edema (grade 1) were observed on the treated skin of the animals. Skin irritation was fully reversible within 24 h (edema) or 48 h (erythema) after exposure to the test substance. No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred. The mean erythema and edema scores after 24, 48 and 72 h were 0.33 and 0 for all 3 animals.
Based on the results of this study, Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters is not irritating to the skin.
Eye irritation
CAS 68334-05-4
An eye irritation study was conducted with Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters according to OECD guideline 405 and in compliance with GLP (Stitzinger, 2010). The undiluted test substance (0.1 mL) was placed into the conjunctival sac of one eye of 3 male New Zealand White rabbits. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Instillation of the test substance resulted in redness of conjunctivae in all three animals, which was fully reversible at the 48 h reading. In addition, conjunctival discharge was observed in the treated eyes of all animals at the 1 h reading. No iridial irritation and corneal opacity was noted during the study. Treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. No evidence of ocular corrosion was seen during the study. Furthermore, no symptoms of systemic toxicity and no mortalities occurred in the animals during the test period. The mean cornea, iris and chemosis scores after 24, 48, and 72 h were 0 for all 3 animals, respectively. The mean score for conjunctivae after 24, 48, and 72 h was 0.3 for all 3 animals.
Based on the results of this study, Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters is not eye irritating.
Conclusion for skin irritation/corrosion and eye irritation
In conclusion, no data is available on the skin and eye irritation potential of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters, but there exists reliable studies from the surrogate substance C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4), which are used for read-across based on the analogue approach and which are indicating no skin and eye irritating properties. Therefore, Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters is not skin and eye irritating.
Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from a structural surrogate. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from a structural surrogate. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Justification for classification or non-classification
Based on read-across from the surrogate substance, the available data on skin and eye irritation/corrosion 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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