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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 261-619-1 | CAS number: 59130-69-7
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating
Eye irritation: 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:
- 15 Oct 1991 - 29 Oct 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany.
- Age at study initiation: approx. 9 months
- Weight at study initiation: approx. 2540 g
- Housing: individual
- Diet: Ssniff rabbit diet K4, Ssniff GmbH, Soest, Germany; ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 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 (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
Reading time points: 1, 24, 48, 72 h and 7 and 14 days after exposure - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the left or right flank
- Type of wrap if used: gauze patch covered with an adhesive air- and vapor-permeable patch and fixed by using a hypoallergenic adhesive gauze-bandage.
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 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:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- 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: Evaluation of the dermal reaction
Skin effect |
Erythema |
Edema |
||||||||
|
1h |
24h |
48h |
72h |
Meana |
1h |
24h |
48h |
72h |
Meana |
Animal No. #1 |
1 |
1 |
1 |
2 |
1.3 |
1 |
1 |
1 |
2 |
1.3 |
#2 |
1 |
1 |
2 |
2 |
1.7 |
1 |
1 |
1 |
2 |
1.3 |
#3 |
1 |
1 |
2 |
3 |
2.0 |
1 |
1 |
1 |
2 |
1.3 |
amean of readings at 24, 48 and 72 hours
Skin effect |
days after exposure |
|
|
7 |
14 |
Animal No. #1 |
i b S |
+ |
#2 |
i b S |
+ |
#3 |
i b S |
+ |
i = irreversible
b = brownish
S = eschar
+ = reversible
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:
- 28 Oct 1991 - 31 Oct 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb: HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany.
- Age at study initiation: approx. 9 months
- Weight at study initiation: approx. 2510 g
- Housing: individual
- Diet: Ssniff rabbit diet K4, Ssniff GmbH, Soest, Germany; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- 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 - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the eyes were thoroughly rinsed with tap water.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- 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 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- 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: Evaluation of the eye reaction
Rabbit No. |
Scoring [h] |
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
||||
1 |
1 |
0 |
0 |
1 |
0 |
|
24 |
0 |
0 |
1 |
0 |
|
48 |
0 |
0 |
1 |
0 |
|
72 |
0 |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0.0 |
0.0 |
0.7 |
0.0 |
|
2 |
1 |
0 |
0 |
1 |
1 |
|
24 |
0 |
0 |
1 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0.0 |
0.0 |
0.3 |
0.0 |
|
3 |
1 |
0 |
0 |
1 |
1 |
|
24 |
0 |
0 |
1 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0.0 |
0.0 |
0.3 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
Irritation to skin by hexadecyl 2-ethylhexanoate was evaluated in a GLP study performed in accordance with OECD guideline 404 (Steiling, 1991). The flank skin of three Kleinrussen rabbits were treated with 0.5 mL of the test substance under semiocclusive conditions for 4 h. The readings 24, 48 and 72 hours later revealed mean erythema scores from 1.3 to 2 in the three animals and a mean edema score of 1.3 in all animals, respectively. All skin effects were fully reversible within the 14 days observation period. Based on these results, no skin irritation by hexadecyl 2-ethylhexanoate was found.
Similar results were found in another study performed according to OECD guideline 404, where only limited data were available (Bouffechoux, 1996). Three New-Zealand breed rabbits were treated with hexadecyl 2-ethylhexanoate on shaved and abraded skin sites. Readings were performed 1, 24, 48 and 72 hours and 7 days after application. The mean scores over 24, 48 and 72 hours were 1.0, 1.7, and 1.7 for erythema and 0.0, 0.7, and 0.7 for edema. Erythema and edema scores were fully reversible within 72 h. The results were only given as the sum of scoring values from intact and scarificed skin sites.
Eye irritation
Eye irritation was evaluated in a GLP study performed according to OECD guideline 405 (Steiling, 1991). 0.1 mL of hexadecyl 2-ethylhexanoate was instilled into the eyes of three Kleinrussen rabbits and was removed by washing with water after 24 h of treatment. While the mean scores after 24, 48 and 72 h for conjunctivae were between 0.3 and 0.7 in the three animals, the mean scores for cornea, iris and chemosis were 0, respectively. Thus, hexadecyl 2-ethylhexanoate was found to be not irritating to eyes.
Another study was also conducted according to OECD guideline 405, but only limited data are available (Bouffechoux, 1996). The eyes of three New-Zealand breed rabbits were single treated with hexadecyl 2-ethylhexanoate and were scored 1, 24, 48 and 72 h and 7 days after treatment. The results were mean conjunctivae scores of 0.3 in all animals while the effects were fully reversible within 48 h. The mean scores for cornea and iris were 0 in all animals, respectively. Thus, this study found hexadecyl 2-ethylhexanoate to be not irritating to eyes.
Justification for selection of skin irritation / corrosion endpoint:
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).
Justification for selection of eye irritation endpoint:
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).
Justification for classification or non-classification
The available data to assess skin and eye irritation of the test substance do not meet the criteria for classification 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.