Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation: not irritating (EU Method B.4, GLP)
Eye irritation: not irritating (OECD 405/EU Method B.5, GLP)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 - 17 Nov 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Broek Institute, Somere, The Netherlands
- Age at study initiation: ca. 13 weeks
- Weight at study initiation: 2393 - 2565 g
- Housing: Animals were individually housed in plastic cages with perforated floors.
- Diet: standard laboratory animal diet (100 g/day, LK-01, diameter 4 mm), obtained from Hope Farms, Worden, The Netherlands
- Water: tap-water, ad libitum via automatic nozzles
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 55 - 75
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
Reading time points: 40 min, 24, 48 and 72 h, 7 and 14 days - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: The test substance was applied to a 6 cm² gauze patch which was attached with a drop of petrolatum to aluminium foil and mounted on permeable tape (Micropore, 3M, St. Paul, USA). This was applied to the dorsal left flank of each animal, the right flank being covered with the same dressing without substance.
- Type of wrap if used: Animals were wrapped in flexible bandage (Coban, 3M, St. Paul, USA).
REMOVAL OF TEST SUBSTANCE
- Washing: After exposure, the remaining test substance was removed, using dry tissue and subsequently a tissue moistened with tap-water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The test results are shown in Table 1. Forty minutes after test substance removal, the exposed skin showed well-defined erythema and slight swelling in two animals and very slight erythema and edema in the third animal. The erythema varied between very slight and well-defined during the following days and had disappeared on Day 14 in all three animals. The edema persisted until the 72 h observation time in all three rabbits.
- Other effects:
- No signs of systemic intoxication were observed in any of the rabbits.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Table 1. Results of the skin irritation study.
Observation time | Rabbit no. | |||||
1 | 2 | 3 | ||||
Erythema | Edema | Erythema | Edema | Erythema | Edema | |
40 min | 1 | 1 | 2 | 2 | 2 | 2 |
24 h | 1 | 1 | 1 | 1 | 1 | 1 |
48 h | 1 | 1 | 2 | 1 | 2 | 1 |
72 h | 1 | 1 | 2 | 1 | 1 | 1 |
7 days | 0 | 0 | 1 | 0 | 1 | 0 |
14 days | 0 | 0 | 0 | 0 | 0 | 0 |
Mean value 24 + 48 + 72 h | 1.00 | 1.00 | 1.67 | 1.00 | 1.33 | 1.00 |
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 16 Aug 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
- Species:
- rabbit
- Strain:
- other: Hsdlf:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.15 and 3.28 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: 2930C Teklad Global Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 2 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: standard ophthalmoscope
EXAMINATIONS
CLINICAL SIGNS: clinical signs of toxicity, if present, were also recorded.
BODY WEIGHT: Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
Minimal conjunctival irritation was noted in both treated eyes 1 and 24 h after treatment and in one treated eye at the 48 h observation. Minimal chemosis was noted in both treated eyes 1 h after treatment persisting in one treated eye at the 24 h observation. Minimal discharge was noted in both treated eyes at the 1 h observation.
One treated eye appeared normal at the 48 h observation and the other treated eye appeared normal at the 72 h observation. - Other effects:
- No further local or systemic effects were reported.
No gain in body weight was noted in one animal and bodyweight loss (-20 g) was noted in the other animal during the study. - 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
Skin irritation
The skin irritation potential of Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated was tested in rabbits in a GLP-compliant study following EU Method B.4 (Weterings and Daamen, 1987). The undiluted test material (0.5 mL) was applied to the intact skin of 3 female rabbits for 4 h under semiocclusive conditions. Skin reactions were evaluated at intervals up to 14 days after treatment. Forty minutes after test substance removal, the exposed skin showed well-defined erythema and slight swelling in two animals and very slight erythema and edema in the third animal. The erythema varied between very slight and well-defined during the following days and had disappeared on Day 14 in all three animals. Edema persisted until the 72 h observation time in all three rabbits. No signs of systemic intoxication were observed in any of the rabbits. The individual mean erythema and edema scores after 24-72 h were 1.0/1.7/1.3 and 1.0/1.0/1.0, respectively.
Based on the study results, the test substance is considered to be not irritating to the skin.
No evidence of skin irritation was observed in the Mouse Local Lymph Node Assay conducted with Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated (Bradshaw, 2012).
Eye irritation
The irritancy potential of Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated to the rabbit eye was assessed in a GLP-compliant study performed according to OECD guideline 405 (Bradshaw, 2012). A volume of 0.1 mL of the undiluted test material was applied into the conjunctival sac of the right of one animal. Ocular reactions were evaluated 1, 24, 48 and 72 h after treatment. Only minimal conjunctival redness, chemosis and discharge were observed, which were fully reversible within 72, 48 and 24 h, respectively. After consideration of the ocular responses produced in the first treated animal, a second animal was treated. Eye reactions in the second animal were limited to minimal conjunctival redness at the 1 and 24 h observations and minimal chemosis and discharge observed 1 h after treatment. No effects on cornea and iris were noted. No clinical signs of toxicity and no adverse effects on body weight were seen. The individual mean conjunctivae/chemosis scores after 24-72 h were 0.7/0.3 and 0.3/0.0, respectively.
The test material is therefore considered to be not irritating to the eye.
Conclusions for irritation / corrosion
The substance Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated has been tested for skin and eye irritation in rabbits. Dermal and ocular reactions were observed, but overall the effects were slight, fully reversible and therefore not sufficient for classification.
Based on the available data, the substance is considered to be not irritating to the skin and eye.
Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.
Justification for selection of eye irritation endpoint:
There is only one study available.
Justification for classification or non-classification
The available data on the skin and eye irritation potential 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.
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.