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EC number: 287-634-3 | CAS number: 85566-24-1
- 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 (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
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:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. The test substance was applied under occlusive conditions for 24 h, no experimental 48 h reading performed. Lack of detail on test material.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure period 24 h, occlusive conditions, no individual scores reported at the 48 h reading time point and lack of detail on test material.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.8 - 2.4 kg - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated site of the same animal served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
Reading time points: 24 and 72 h - Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Type of wrap if used: occlusive patches (1" x 1" gauze, covered by adhesive tape). Following application of the test material the entire trunk of each animal was covered with an impermeable occlusive wrapping.
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values was assumed to be the same as those at 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values was assumed to be the same as those at 24 h
- Irritant / corrosive response data:
- No edema or erythema were seen in any of the animals tested.
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Lack of detail on test material.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of detail on test material.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.8-2.4 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required; the untreated eye served as control" in the remarks field
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 h and 4 and 7 days - Number of animals or in vitro replicates:
- 6 ( 3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after instillation.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-held lens - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.23
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- In 2/6 animals no irritation was observed. However, in the other animals mild to moderate conjunctival irritation and/or corneal opacity was observed but was fully reversed within 72 h. Also, in 4/6 animals’ mild iritis was observed but was reserved within 24 h. (please see table 1 for more detail).
- 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 eye irritation study.
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
conjunctivae
|
iris
|
cornea
|
||
redness |
swelling |
redness |
swelling |
|||||||
1
|
|
|
|
|
|
|
||||
24 |
0 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.0 |
0.0 |
0.0 |
0.0 |
Time to reversion |
0.0 |
0.0 |
0.0 |
0.0 |
|
2
|
|
|
|
|
|
|
|
|||
24 |
1 |
1 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.3 |
0.3 |
0.0 |
0.0 |
Time to reversion |
48.0 |
48.0 |
0.0 |
0.0 |
|
3
|
|
|
|
|
|
|
|
|||
24 |
1 |
2 |
1 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.3 |
0.7 |
0.3 |
0.0 |
Time to reversion |
48.0 |
48.0 |
48.0 |
0.0 |
|
4
|
|
|
|
|
|
|
|
|||
24 |
0 |
0 |
0 |
1 |
||||||
48 |
0 |
0 |
0 |
1 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.0 |
0.0 |
0.0 |
0.7 |
Time to reversion |
0.0 |
0.0 |
0.0 |
72.0 |
|
5
|
|
|
|
|
|
|
|
|||
24 |
0 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.0 |
0.0 |
0.0 |
0.0 |
Time to reversion |
0.0 |
0.0 |
0.0 |
0.0 |
|
6
|
|
|
|
|
|
|
|
|||
24 |
1 |
3 |
1 |
1 |
||||||
48 |
1 |
0 |
0 |
1 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.7 |
1.0 |
0.3 |
0.7 |
Time to reversion |
72.0 |
48.0 |
48.0 |
72.0 |
|
|
|
|||||||||
|
Time [h] |
conjunctivae
|
iris |
cornea |
||||||
|
redness |
swelling |
|
|
avg. time to reversion |
28.0 |
24.0 |
16.0 |
24.0 |
|
average score |
|
|
|
|
|
|
||||
24 |
0.50 |
1.00 |
0.33 |
0.33 |
||||||
48 |
0.17 |
0.00 |
0.00 |
0.33 |
||||||
72 |
0.00 |
0.00 |
0.00 |
0.00 |
||||||
24+48+72 |
0.67 |
1.00 |
0.33 |
0.66 |
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, C14 -18, C14 -18 -alkyl esters (CAS 85566-24-1) was investigated in a study performed equivalent to OECD TG 404 (Croda, 1976b). 0.5 g of the undiluted test substance was applied to the shaved skin of 6 rabbits, 3 of each sex and covered with an occlusive dressing for 24 h. No edema or erythema was observed in any of the animals during the 72 h observation period. Based on these results, the test substance is not considered to be a skin irritant.
Eye irritation
The eye irritation potential of fatty acids, C14-18, C14-18-alkyl esters (CAS 85566-24-1) was investigated in a study performed equivalent to OECD TG 405 (Croda, 1976c). 0.1 mL of the undiluted test material was placed into the conjunctival sac of one eye of 6 New Zealand White rabbits. The other eye remained untreated and served as control. The eyes were then examined and scored at 24, 48 and 72 h, 4 and 7 days after application. In 2/6 animals, no irritation was observed. However, in the remaining animals, mild to moderate conjunctival irritation and/or corneal opacity were observed but was fully reversed within 72 h. The mean conjunctivae score after 24, 48 and 72 h was 0.7 (1/6), 0.33 (2/6) and 0 (3/6).
The mean cornea, iris, and chemosis scores after 24, 48, and 72 h were 0.23, 0.1 and 0.33 for all 6 animals, respectively. These effects were fully reversed by 72 h. Based on these results, the test substance is not considered to be an eye irritant.
Conclusions for irritation / corrosion
Based on the available data on skin irritation, fatty acids, C14-18, C14-18-alkyl esters (CAS 85566 -24 -1) is not considered to be skin irritating. Furthermore, the results of the eye irritation study do not indicate an eye irritation potential of fatty acids, C14-18, C14-18-alkyl esters (CAS 85566-24-1).
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, C14-18, C14-18-alkyl esters (CAS 85566 -24 -1) 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 respiratory irritation.
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