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EC number: 204-010-8 | CAS number: 112-85-6
- 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 (QSAR): not irritating
Skin irritation (OECD 404): not irritating; CAS# 57-10-3, C16 (Kästner, 1988)
Skin irritation (Federal Guidelines): not irritating; CAS# 57-11-4, C18 (USFHSA, 1974)
Skin irritation (human, closed epicutaneous test): not irritating; CAS# 57-10-3, C16 (Matthies, 1988)
Skin irritation (human, repeated occlusive patch test, 1M): not irritating CAS# 57-10-3, C16; CAS# 57-11-4, C18 (Stillman et al., 1975)
Eye irritation (QSAR): not irritating
Eye irritation (OECD 404): not irritating; CAS# 57-10-3, C16 (Kästner, 1988)
Eye irritation (Federal Guidelines): not irritating; CAS# 57-11-4, C18 (USFHSA, 1974)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- other: Qualitative SAR based on structural alerts and PC data
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Qualitative SAR based on structural alerts and PC data
- Justification for type of information:
- QSAR prediction
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Determination with the OECD QSAR Toolbox v2.2 whether inclusion rules (based on structural alerts) and exclusion rules (based on PC parameters) are fulfilled for skin irritation/corrosion for docosanoic acid. The results were compared with erucic acid.
- GLP compliance:
- no
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- other: not applicable
- Controls:
- other: not applicable
- Duration of treatment / exposure:
- not applicable
- Observation period:
- not applicable
- Number of animals:
- not applicable
- Irritation / corrosion parameter:
- other: inclusion rules (based on structural alerts)
- Run / experiment:
- Docosanoic acid
- Remarks on result:
- other: no alerts, thus neither irritating nor corrosive
- Irritation / corrosion parameter:
- other: exclusion rules (based on PC parameters)
- Run / experiment:
- Docosanoic acid
- Remarks on result:
- other: neither irritating nor corrosive
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Remarks:
- Criteria used for interpretation of results: Qualitative SAR based on structural alerts and PC data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 29 Jan - 04 Feb 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- application under occlusion; 4 animals used;
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach/D.
- Weight at study initiation: mean: 2452.5 g
- Housing: individually housed in rabbit batteries, Fa. Heinkel, 7343, Kuchen, D
- Diet: Zucht- /Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, 4902 Bad Salzuflen; ad libitum
- Water: ad libitum tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 - 21
- Humidity (%): ca. 45 - 50
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days; since no scores could be observed within 3 days the experiment was cancelled due to animal welfare reasons; therefore the short observation period of 3 days does not represent a deviation to the OECD Guideline 404
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: ~2.5 x 2.5 cm
- Type of wrap if used: plastic foil with adhesive plasters and an acrylastic band aid
SCORING SYSTEM: Skin irritation/corrosion was evaluated according to Draize. - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin reactions were observed.
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national standards (DIN, etc.)
- Qualifier:
- according to guideline
- Guideline:
- other: Patch test / Revised (1964) Federal Hazardous Substance Act
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
Reading time points: 24 h and 72 h - Number of animals:
- 6
- Details on study design:
- Fur was removed from the back of each of six rabbits by clipping the saddle of the trunk area. One area of skin was abraded by making minor incisions with a hypodermic needle. 0.5 mL of test material was applied to 1 inch gauze patches. The patches were placed on both intact skin and abraded skin of each rabbit and secured with adhesive tape, rubber dental damming secured with staples, and gauze wound loosely around the trunk. The animals were then immobilized for 24 hours in wooden stocks. After 24 hours, the patches were removed and the skin cleaned by gently sponging with a moistened towel. The skin was examined immediately after removal of the patches (24 hr reading) and again at 72 hrs. At each examination the skin was scored for presence and severity of erythema/eschar formation and edema formation.
- 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: not applicabe
- Remarks on result:
- other: intact sites
- 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: not applicable
- Remarks on result:
- other: intact sites
- Irritant / corrosive response data:
- No signs of skin irritation were observed on intact or abraded sites at either reading time point.
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Referenceopen allclose all
Table 1: Physico-chemical parameters for docosanoic acid and erucic acid, on which the skin irritation/corrosion potential is predicted:
Chemical name, short notation |
Docosanoic acid, C22 |
Erucic acid, C22’ |
Molecular weight, g/mol |
340.6 |
338.6 |
log Kow |
9.91 (KOWWIN v1.68) |
9.69 (KOWWIN v1.68) |
Melting point, °C |
81 (EPISUITE exp. database) |
33.5 (EPISUITE exp. database) |
Vapour pressure Pa |
6.5E-5 (MPBPWIN v1.43 at 25 °C) |
1.5E-4 (MPBPWIN v1.43 at 25 °C) |
Water solubility, mg/L |
0.016 mg/L (EPISUITE exp. database at room temperature) |
insoluble (Merck Index) |
Table 2: Application of exclusion rules for docosanoic acid (C22) and erucic acid (C22')
Rule |
Class of substances |
Positive for C22, C22’: |
If positive, than NOT: |
log Kow > 9 |
all |
both substances |
R34, R35 |
WS < 0.1 mg/L |
C, H, O only |
both substances |
R34, R35 |
MP > 55 °C |
C, H, O only |
C22 only |
R34, R35, R38 |
VP < 1E-4 Pa |
C, H, O only |
C22 only |
R38 |
MW > 350 |
C, H, O only |
neither substance |
R34, R35 |
LS < 0.01 g/kg |
all |
neither substance |
R34, R35 |
ST > 62 mN/m |
C, H, O only |
rule discarded due to low water solubility |
R34, R35 |
WS: water solubility
MP: melting point
VP: vapour pressure
MW: molecular weight
LS: lipid solubility
ST: surface tension
Material (0.5 mL) was applied via a one-inch-square surgical gauze patch to intact and abraded-skin sites. Patches were held in place for 24 hours. Reactions were scored immediately after patch removal and two days later (72 hours).
Scores for Skin Irritation
Rabbit No. |
24 hrs |
72 hrs |
|
43 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
44 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
45 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
46 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
47 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
48 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- other: Qualitative SAR based on structural alerts and PC data
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Qualitative SAR based on structural alerts and PC data
- Justification for type of information:
- QSAR prediction
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Determination with the OECD QSAR Toolbox v2.2 whether inclusion rules (based on structural alerts) and exclusion rules (based on PC parameters) are fulfilled for eye irritation/corrosion for docosanoic acid. The results were compared with erucic acid.
- GLP compliance:
- no
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Vehicle:
- other: not applicable
- Controls:
- other: not applicable
- Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- not applicable
- Irritation parameter:
- other: inclusion rules (based on structural alerts)
- Basis:
- other: docosanoic acid
- Remarks on result:
- other: no alerts, thus neiter irritating nor corrosive
- Irritation parameter:
- other: exclusion rules (based on PC parameters)
- Basis:
- other: docosanoic acid
- Remarks on result:
- other: not R34, R35, R36 and R41
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Remarks:
- Criteria used for interpretation of results: Qualitative SAR based on structural alerts and PC data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 26 Feb - 04 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study tested with the source substance CAS 57-10-3. In accordance 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)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrussen Chbb
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HM / Fa. Thomae, Biberach, Germany
- Weight at study initiation: ca. 2640 g
- Housing: individually (Fa. Heinkel, Kuchen, Germany)
- Diet: ad libitum Altromin diet 2023, Altromin GmbH, Lage, Germany
- Water: ad libitumcommunity tap water; ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eyes served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 3 days (since only minor scores were observed that fully returned to normal within 3 days the experiment was cancelled due to animal welfare reasons; therefore the reduced observation period does not represent a deviation to the OECD Guideline)
Reading time points: 1 h, 6 h, 24 h, 48 h, 72 h after administration - Number of animals or in vitro replicates:
- 4
- Details on study design:
- TOOL USED TO ASSESS SCORE: fluorescein
Ca. 24 hours prior to administration the eyes of the rabbits were checked with 0.1 mL 0.5% fluorescein sodium solution to detect eye lesions. If there are no stainings after rinse off, the cornea is considered to be intact. 24 hours after application of the test item and macroscopical determination of mucosal irritation the treatment with fluorescein sodium solution was repeated. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: exudation
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Studies conducted pre-GLP standards
- Qualifier:
- according to guideline
- Guideline:
- other: Regulations for the Enforcement of the Federal Hazardous Substances Act. F.R. Sept. 17, 1964
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino
- Vehicle:
- not specified
- Controls:
- other: the untreated left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Observation period (in vivo):
- Reading time points: 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No Lesions were observed after application of 0.1 mL test substance in rabbits eyes.
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Referenceopen allclose all
Table 1: Physico-chemical parameters for docosanoic acid and erucic acid, on which the skin irritation/corrosion potential is predicted:
Chemical name, short notation |
Docosanoic acid, C22 |
Erucic acid, C22’ |
Molecular weight, g/mol |
340.6 |
338.6 |
log Kow |
9.91 (KOWWIN v1.68) |
9.69 (KOWWIN v1.68) |
Melting point, °C |
81 (EPISUITE exp. database) |
33.5 (EPISUITE exp. database) |
Vapour pressure Pa |
6.5E-5 (MPBPWIN v1.43 at 25 °C) |
1.5E-4 (MPBPWIN v1.43 at 25 °C) |
Water solubility, mg/L |
0.016 mg/L (EPISUITE exp. database at room temperature) |
insoluble (Merck Index) |
Table 2: Application of exclusion rules for docosanoic acid (C22) and erucic acid (C22')
Rule |
Class of substances |
Positive for C22, C22’: |
If positive, than NOT: |
log Kow > 9 |
all |
both substances |
R34, R35, R36, R41 |
WS < 0.1 mg/L |
all |
both substances |
R34, R35, R36, R41 |
MP > 55 °C |
C, H, O only |
C22 only |
R34, R35 |
MW > 380 |
C, H, O only |
neither substance |
R34, R35, R36, R41 |
LS < 0.01 g/kg |
all |
neither substance |
R34, R35, R36, R41 |
WS: water solubility
MP: melting point
MW: molecular weight
LS: lipid solubility
Tab.1: Conjunctival reactions after application of 0.1 g Edenor C16 - 92/94 (undiluted, permanent, 4 male rabbits)
Time point after application |
Redness |
Chemosis |
Exudation |
|||
Individual data |
Average |
Individual data |
Average |
Individual data |
Average |
|
60 min |
1 / 1 / 1 / 1 |
1.00 |
0 / 1 / 1 /1 |
0.75 |
0 / 0 / 0 / 1 |
0.25 |
6 h |
1 / 2/ 1 / 1 |
1.25 |
0 / 0 / 0 / 0 |
0 |
2 / 0 / 0 / 1 |
0.75 |
24 h |
1 / 1 / 1 / 1 |
1.00 |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
48 h |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
72 h |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
Animal No. (from left to right) 790, 796, 798, 799
Reactions on the cornea and iris were not observed. The conjunctival reactions were slight and disappeared totally within 48 hours. Palmitic acid is not irritating to eyes / mucosa under the test conditions.
Scores for Ocular Lesions
Rabbit No. |
24 hrs. |
48 hrs. |
72 hrs. |
|
13 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
14 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
15 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
16 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
17 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
18 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
No data on skin irritation/corrosion is available for docosanoic acid. Therefore skin irritation effects are predicted from adequate and reliable data for source substances by read-across to the target substance within the group applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, the source substances structurally closest to the target substance are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Thus, studies with C16 fatty acid (palmitic acid) and C18 fatty acid (stearic acid) are used for hazard assessment.
Skin irritation by palmitic acid (CAS# 57-10-3) was evaluated in a study performed under GLP according to OECD Guideline 404 with the exception, that the test was performed under occlusive condition (Kästner, 1988). Four Himalayan rabbits received an application of 0.5 g palmitic acid to the shaved skin under occlusion for 4 hours. The readings 24, 48, and 72 hours after application did not reveal any signs of irritation, thus resulting in mean scores of 0 for erythema and edema, respectively. As a consequence, the test was terminated after the 72 h reading. Based on the results, palmitic acid can be regarded as not irritating to skin.
In a study with human subjects, palmitic acid and 19 other substances were investigated with a closed epicutaneous test. 10 µL of palmitic acid at a concentration of 50% were applied to the back of the volunteers for 24 hours using a Large Finn Chamber (Matthies, 1988). The reactions were scored for edema, erythema, scaling and fissures 1, 6, 24, 48, 72 and 144 hours after application. As result, for all readings the score 0 was found. In another study with human subjects, 12.8% and 25.6% (w/v) palmitic acid was applied daily under occlusive patch tests to human skin until detectable erythema appeared (Stillman et al., 1975). Only one single subject showed erythema after six days of repeated application of 12.8% palmitic acid.
Skin irritation by stearic acid (CAS# 57-11-4) was evaluated in a study performed in accordance with US Federal Guidelines (USFHSA, 1974). 0.5 mL of stearic acid was applied to the abraded skin of 6 New Zealand White rabbits under occlusion for 24 hours.at 24 and 72 hours after application revealed no signs of irritation. Although a longer application under occlusion than suggested according to actual guidelines was applied, the resulting scores were 0 for erythema and edema, respectively. Based on this, stearic acid can be regarded as not irritating to skin.
In a study with human subjects, daily application of 28.4% stearic acid (w/v) under occlusive conditions did not cause irritation in any of the 10 subjects until the termination of the study on day 10 (Stillman et al., 1975).
Based on the available data, palmitic acid and stearic acid have no skin irritation potential.
Due to the structural and functional similarities of members within the category including docosanoic acid, palmitic acid and stearic acid, the same result could be expected for docosanoic acid. To support this negative result, a qualitative SAR method has been applied for docosanoic acid. By means of the OECD QSAR toolbox (v2.2) it can be determined whether inclusion rules (examination for the presence of structural alerts) and exclusion rules (on the basis of physico-chemical properties) are fulfilled for skin irritation/corrosion. No alerts were detected for docosanoic acid and a skin irritation/corrosion classification (R34, R35, R38) can be excluded based on the basis of log Kow, water solubility, melting point and vapour pressure based rules.
In conclusion, docosanoic acid is not regarded as irritating to skin based on a weight of evidence approach.
Eye
No data on eye irritation is available for docosanoic acid.Therefore eye irritation effects are predicted from adequate and reliable data for source substances by read-across to the target substance within the group applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, the source substances structurally closest to the target substance are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Thus, studies with C16 fatty acid (palmitic acid) and C18 fatty acid (stearic acid) are used for hazard assessment.
Eye irritation by palmitic acid (CAS# 57-10-3) was analysed in a study performed in accordance with GLP and according to OECD Guideline 405 (Kästner, 1988). 0.1 g of palmitic was instilled into the right eye each of four Himalayan rabbits while the untreated left eyes served as control. The reactions were examined 1, 6, 24, 48, and 72 hour after administration and resulted in mean scores of 0, 0, 0.3, 0 and 0 for corneal opacity, iris, conjunctival redness and chemosis, and exudation, respectively. Since all signs were subsided on day three after instillation, the study was terminated on that day due to animal welfare reasons. Based on the findings, palmitic acid can be regarded as not irritating to eyes.
Palmitic acid was also found to be not irritating to eyes in a study performed according to national guidelines since no signs of irritation were noted in any of six treated rabbits (Briggs et al., 1976).
Eye irritation by stearic acid (CAS# 57-11-4) was examined in a non-GLP study according to US Federal Guidelines (USFHSA, 1974). 0.1 g stearic acid was applied into the eyes of six albino rabbits. The untreated left eye of each animal served as control. The eyes were examined at 24, 48 and 72 h and scored for corneal opacity, iris lesions, conjunctival redness, chemosis and discharge. No lesions were observed in any of the animals, thus the overall score for all irriation parameters was 0.
Thus, palmitic acid and stearic acid are not irritating to the eyes based on the available animal studies.
For docosanoic acid a qualitative SAR based on structural alerts and PC data was performed to make a prediction for its eye irritation potential. No structural alerts for eye irritation have been determined for docosanoic acid and classification as R34, R35, R36 and R41 could be excluded due to the log Kow, water solubility and melting point based rules.
In conclusion by means of read-across based on a category approach and taking into account QSAR predictions, docosanoic acid is not considered as irritating to eyes.
References:
Briggs, G.B. et al. (1976). Safety studies on a series of fatty acids. Am Ind Hyg Assoc J. 37(4):251-253. International Bio-Research, Miamiville, Ohio, USA.
Justification for classification or non-classification
By means of read-across based on a category approach, the available data on skin and eye irritation does not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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