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EC number: 245-205-8 | CAS number: 22766-83-2
- 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, rabbit: not irritating
Eye, rabbit: 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:
- 23 - 26 Jun 1986
- 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 was performed, the analytical purity was not reported.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Apr 2002
- Deviations:
- yes
- Remarks:
- exposure period 24 h, occlusive conditions, no experimental 48 h reading performed, analytical purity not reported
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- 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: 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
Reading time points: 24 and 72 h - Number of animals:
- 6 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #5 and #6
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Mean scores for intact skin only.
- Irritation parameter:
- erythema score
- Basis:
- animal: #2 and #4
- Time point:
- other: mean over 24, 48 and 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 were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Mean scores for intact skin only.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Mean scores for intact skin only.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 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: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Mean scores for intact skin only.
- Irritant / corrosive response data:
- Intact skin:
1/6 animals had slight erythema (score 1) at the 24-hour and 72-hour reading time points, while 3/6 rabbits had slight erythema at the 24-hour reading time point only (see Table 1). No edema was observed in any animals at any time point.
Abraded skin:
1/6 animals had slight erythema (score 1) at the 24-hour and 72-hour reading time point, while 4/6 rabbits had slight eythema at the 24-hour reading time point only (see Table 1). No edema was observed in any animals at any time point. - 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: individual erythema and edema scores for intact skin
Rabbit No. |
||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
24 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
48 h |
No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
|
|||||||||||
72 h |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: calculation of mean scores for intact skin
|
Rabbit No. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
Mean value 24+48+72 h |
0.67 |
0 |
0 |
0 |
1.00 |
0 |
0 |
0 |
0.67 |
0 |
0.67 |
0 |
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. The analytical purity of the test substance was not reported.
- Qualifier:
- according to guideline
- Guideline:
- other: Journal Officiel, 21.04.1971, amended on 05.06.1973
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted Oct 2012
- Deviations:
- yes
- Remarks:
- analytical purity not reported
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: the animals are housed individually in polystyrene cages (540 mm x 360 mm x 315 mm) with a perforated polystyrene floor
- Diet: 150 g complete maintenance food, granulés lapin Entretien '117' (UAR, Villemasson/Orgel, France)
- Water: softened and filtered drinking water, ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): minimum 20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- Single instillation without rinsing
- 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 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: opthalmoscope; supplemetary assessments are performed using a hand-slit lamp, if necessary - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 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:
- animal: #1, #2, #3 and #5
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #3, #4, #5 and #6
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #3, #5 and #6
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- At the 1-h reading time point 6/6 rabbits had slight to moderate conjunctivae and chemosis (score 1 – 2), and effects on the iris (score 1). At the 24-h reading time point, slight conjunctivae (score 1) was observed in 1/6 rabbits, and slight chemosis (score 1) was seen in 4/6 other rabbits. Chemosis (score 1) was still present in 1/6 rabbits 48 h after instillation. Iris effects were observed in 2/6 animals at the 24-h reading time point, persisting in 1/6 until 48 h after instillation. All eye irritation effects had cleared completely within 72 h. No cornea opacity was observed in any rabbit at any time point (see Table 1).
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not irritating
DSD: not irritating
Reference
Table 1. Individual eye irritation scores
Rabbit #
|
Time
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 h |
1 |
1 |
1 |
0 |
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h 7 d |
0 0 |
0 0 |
0 0 |
0 0 |
|
Average* |
0.0 |
0.0 |
0.0 |
0.0 |
|
2
|
1 h |
1 |
2 |
1 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h 7 d |
0 0 |
0 0 |
0 0 |
0 0 |
|
Average* |
0.33 |
0.0 |
0.0 |
0.0 |
|
3
|
1 h |
2 |
2 |
1 |
0 |
24 h |
0 |
1 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h 7 d |
0 0 |
0 0 |
0 0 |
0 0 |
|
Average* |
0.0 |
0.33 |
0.0 |
0.0 |
|
4
|
1 h |
2 |
2 |
1 |
0 |
24 h |
0 |
1 |
1 |
0 |
|
48 h |
0 |
0 |
1 |
0 |
|
72 h 7 d |
0 0 |
0 0 |
0 0 |
0 0 |
|
Average* |
0.0 |
0.33 |
0.67 |
0.0 |
|
5
|
1 h |
2 |
2 |
1 |
0 |
24 h |
0 |
1 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h 7 d |
0 0 |
0 0 |
0 0 |
0 0 |
|
Average* |
0.0 |
0.33 |
0.0 |
0.0 |
|
6
|
1 h |
1 |
2 |
1 |
0 |
24 h |
0 |
1 |
1 |
0 |
|
48 h |
0 |
1 |
0 |
0 |
|
72 h 7 d |
0 0 |
0 0 |
0 0 |
0 0 |
|
Average* |
0.0 |
0.67 |
0.33 |
0.0 |
*(24h+48h+72h)/3
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
CAS 22766-83-2
A skin irritation study was performed with 2-octyldodecyl myristate (CAS 22766-83-2), according to a protocol similar to OECD guideline 404 (Masson, 1986). 0.5 mL of the test substance was applied to the shaved and abraded skin of 6 male rabbits and held in place by an occlusive dressing for 24 hours. The skin irritation effects were scored 24 and 72 hours after patch removal. At the intact skin site 1/6 animals had slight erythema (score 1) at the 24-hour and 72-hour reading time points, while 3/6 rabbits had slight erythema at the 24-hour reading time point only. No edema was observed in any animals at any time point. The results of the abraded skin sites were comparable to the results of the intact skin sites after test substance application, but were not taken into account for hazard assessment. There was no 48-hour reading time point. To be able to calculate the mean scores, the 48-hour scores were assumed to be the same as those determined 24 hours after patch removal (worst case assumption). The mean erythema scores (over 24, 48 and 72 hours) were 0.67, 0, 1, 0, 0.67 and 0.67 while all the mean edema scores (over 24, 48 and 72 hours) were 0. The test substance is not considered to be irritating to the skin.
Eye irritation
CAS 22766-83-2
An eye irritation study was performed with 2-octyldodecyl myristate (CAS 22766-83-2) according to the guideline published in ‘Journal Officiel, 21.04.1971, amended on 05.06.1973’, which is similar to OECD guideline 405 (Guillot, 1982). 0.1 mL of the test substance was instilled into the eyes of 6 male New Zealand White rabbits. The animals were observed for 72 hours and scoring according to Draize was performed 1, 24, 48, and 72 hours, and 4 and 7 days after application. The eyes were not rinsed. At the 1-hour reading time point 6/6 rabbits had slight to moderate conjunctivae and chemosis (score 1 – 2), and effects on the iris (score 1). At the 24-hour reading time point, slight conjunctivae (score 1) was observed in 1/6 rabbits, and slight chemosis (score 1) was seen in 4/6 other rabbits. Chemosis (score 1) was still present in 1/6 rabbits 48 hours after instillation. Iris effects were observed in 2/6 animals at the 24-hour reading time point, persisting in 1/6 until 48 hours after instillation. All eye irritation effects had cleared completely within 72 hours. No cornea opacity was observed in any rabbit at any time point. The mean cornea score (over 24, 48 and 72 hours) was 0, while the mean iris score was 0, 0, 0, 0.67, 0 and 0.33. The mean conjunctivae score (over 24, 48 and 72 hours) was 0, 0.33, 0, 0, 0, and 0. The mean chemosis score (over 24, 48 and 72 hours) was 0, 0, 0.33, 0.67, 0.33 and 0.33. Based on the results of the study, the test substance is not considered irritating to the eyes.
Overall conclusion for skin and eye irritation
The available data did not show any skin or eye irritation effects. Therefore, 2-octyldodecyl myristate is not considered to be a skin irritant or an eye irritant.
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 skin and eye irritation 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.
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