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EC number: 273-110-1 | CAS number: 68938-03-4 The complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isononanal. It consists predominantly of C6 olefins and paraffins and C9 alcohols and aldehydes and boiling in the range of approximately 110°C to 202°C (230°F to 396°F).
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 January 2010 - 03 February 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with international guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Octene, hydroformylation products, low-boiling
- EC Number:
- 273-110-1
- EC Name:
- Octene, hydroformylation products, low-boiling
- Cas Number:
- 68938-03-4
- IUPAC Name:
- Octene, hydroformylation products, low-boiling
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Oxooil LS9
- Substance type: Industrial material
- Physical state: liquid
- Analytical purity: 95.3%
- Purity test date: Not reported
- Lot/batch No.: 13.06.2008 0649/82531
- Expiration date of the lot/batch: 8 June 2010
- Stability under test conditions: Not stated
- Storage condition of test material: Refrigerated, in the dark.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18.5 to 20.8 g
- Housing: Individually in polycarbonate cages with woodflake bedding, Nestlets and mouse houses for environmental enrichment.
- Diet (e.g. ad libitum): standard rodent diet (Rat and Mouse No. 1 Maintenance Diet) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 40 to 70
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 19 January 2010 To: 02 February 2010
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 10, 25 and 50% v/v with the vehicle
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility:
- Irritation: Mouse dosed with 25 µL of test substance (50% v/v) to the dorsal surface of each ear to 3 consecutive days. No signs of irritation. This dose chosen as maxiumum dose for the main study.
- Lymph node proliferation response: Not investigated
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: if at least one concentration of the test substance results in a three-fold greater increase in 3H-methyl thymidine incorporation compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 μl of the appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was appled to the dorsal surface of each ear using an automatic micropipette. The test substance was spread over the entire dorsal surface of the ear usingthe tip of the pipette. In the main phase of the study, five days following the first topical application of test substance (Day 6) all mice were injected via the tail vein with 50 μl of phosphate buffered saline containing 3H-methyl Thymidine (3HTdR: 80 μCi/mL) giving a nominal 20 μCi to each mouse. The injection into the tail vein was carried out using a plastic syringe and needle after the mouse had been heated in a warming chamber.
In the main phase of the study, five hours following the administration of 3HTdR on Day 6 all mice were humanely killed by carbon dioxide asphyxiation and the draining auricular lymph nodes excised and pooled for each experimental group. 1.0 mL of phosphate buffered saline was added to the pooled lymph nodes for each group.
A single cell suspension of lymph node cells (LNC) was prepared by gentle mechanical disaggregation through a stainless steel gauze (200 mesh size). The pooled LNC were then washed by adding 10 mL phosphate buffered saline, pelleted at 190 x g for 10 minutes and resuspended. The cells were washed twice again and resuspended in 3 mL trichloroacetic acid (TCA: 5%) following the final wash.
After overnight incubation with 5% TCA at 4°C, the precipitate was recovered by centrifugation and resuspended in 1 mL 5% TCA and transferred to 10 mL Ultima gold scintillation fluid on Day 7. 3HTdR incorporation was measured by β-scintillation counting. The proliferative response of LNC was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A study was performed to confirm the sensitivity and reliability of the experimental technique used at Huntingdon Life Sciences to detect skin sensitization potential. The study was performed using the murine local lymph node assay (OECD 429 individual animal approach) and a known moderate sensitizer – hexyl cinnamic aldehyde (HCA). This study was conducted between the 14 and 20 October 2009 using ten mice of the
CBA/ca strain. The positive control study is considered to be valid if the results from the HCA group have a three-fold greater increase in 3HTdR incorporation compared to control values. In this assay the test/control ratio obtained for HCA at 25% was 6.0. This indicates that HCA demonstrates the potential to induce skin sensitization (delayed contact hypersensitivity) and confirms the sensitivity of the technique to detect sensitization potential.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 4.7
- Test group / Remarks:
- 5 (50 % v/v)
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 4 (25 % v/v)
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 3 (10 % v/v)
Any other information on results incl. tables
Table 1 Group dpm/node and test/control ratios
Group |
Concentration % v/v |
Group mean dpm/node |
Number of lymph nodes per group |
dpm/node |
test/control ratio†(SI) |
Classification + = positive - = negative |
2 |
AOO |
6121.60 |
8.0 |
759.32 |
n/a |
n/a |
3 |
10 |
4936.20 |
8.0 |
611.14 |
0.8 |
- |
4 |
25 |
8534.30 |
8.0 |
1060.91 |
1.4 |
- |
5 |
50 |
28683.60 |
8.0 |
3579.57 |
4.7 |
+ |
AOO Acetone:olive oil (4:1 v/v)
† Test/control ratio of greater than 3.0 indicates a positive result
dpm Disintegrations per minute (Less mean background count of 47.05 dpm)
n/a Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- As a SI of 3 or more was recorded for highest concentration tested, Oxooil LS9 was considered to have the potential to cause skin sensitization (delayed contact hypersensitivity). The EC3 was calculated and determined to be 37% v/v.
- Executive summary:
A study was performed at the Laboratories of Huntingdon Life Sciences, Alconbury, UK, on behalf of Evonik Oxeno GmbH. , to assess the skin sensitisation potential of Oxooil LS9 using the murine local lymph node assay. The study was conducted to GLP and in accordance with OECD Guideline 429 and EU Method B.42. Three groups of four mice were treated by daily application to the dorsal surface of both ears for three consecutive days with 25 µl of 10%, 25% or 50% Oxooil LS9 in 4:1 v/v acetone:olive oil. A similarly constituted control group received vehicle alone. The proliferative response of the lymph node cells (LNC) from the draining auricular lymph nodes was assessed five days following the initial application, by measurement of the incorporation of 3H-methyl Thymidine (3HTdR) by β-scintillation counting of LNC suspensions. The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio). The test substance is regarded as a sensitizer if at least one concentration of the chemical results in a three-fold greater increase in 3HTdR incorporation compared to control values.
In this assay the test/control ratios obtained for 10, 25 and 50% v/v were 0.8, 1.4 and 4.7 respectively which indicates that Oxooil LS9 showed the potential to induce skin sensitization. The EC3 was calculated and determined to be 37% v/v.
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