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EC number: 271-240-3 | CAS number: 68526-92-1 A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isotridecanal from the hydroformylation of dodecene. It consists predominantly of C10-12 olefins and paraffins and C13 alcohols and aldehydes and boils in the range of approximately 160°C to 253°C (320°F to 487°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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- between 23 July 2008 and 26 August 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affcet the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection - 21/08/07 Date of Signature - 15/10/07
Test material
- Reference substance name:
- Dodecene, hydroformylation products, low-boiling
- EC Number:
- 271-240-3
- EC Name:
- Dodecene, hydroformylation products, low-boiling
- Cas Number:
- 68526-92-1
- Molecular formula:
- The substance consists of 46 isomers of unsaturated and branched dodecene structures (see Test Report No. A170002983).
- IUPAC Name:
- Dodecene, hydroformylation products, low-boiling
- Details on test material:
- - Sponsor's identification: Oxooil LS 13 (CAS No. 68526-92-1)
- Description: Clear colourless liquid
- Date received: 14 July 2008
- Storage conditions : room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 14
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped free from fur using veterinary clippers
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): Undiluted as supplied
VEHICLE:
Not applicable - Duration of treatment / exposure:
- One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four hours.
- Observation period:
- Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.
- Number of animals:
- One rabbit was initially treated. After consideration of the skin reactions produced in the first animal, two additional animals were treated.
- Details on study design:
- TEST SITE
- Area of exposure: 3 areas each 2.5 cm x 2.5 cm
- % coverage: Not recorded
- Type of wrap if used: surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application.
SCORING SYSTEM:
Standard EU Classification and Labelling Scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Light brown discolouration of the epidermis, Loss of skin elasticity and Loss of skin flexibility at 48, 72 hours and 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- 3-Minute Exposure Period:
The individual scores for erythema/eschar and oedema are given in Table 1.
Well-defined erythema and very slight oedema were noted at the treated skin site at the 24 and 48‑hour observations with very slight erythema and very slight oedema at the 72‑hour observation. Other skin reactions noted at the treated skin site at the 48-hour observation were loss of skin elasticity and light brown discolouration of the epidermis with loss of skin elasticity and crust formation noted at the 72‑hour observation. Slight desquamation was noted at the treated skin site at the 7-day observation.
The treated skin site appeared normal at the 14-day observation.
1-Hour Exposure Period:
The individual scores for erythema/eschar and oedema are given in Table 1.
Very slight erythema was noted at the treated skin site one hour after patch removal with well‑defined erythema and very slight oedema noted at the 24, 48 and 72-hour observations. Other skin reactions noted at the treated skin site at the 48 and 72-hour observations were loss of skin flexibility and/or elasticity and light brown discolouration of the epidermis. Moderate desquamation was noted at the treated skin site at the 7-day observation.
The treated skin site appeared normal at the 14-day observation.
4-Hour Exposure Period:
The individual scores for erythema/eschar and oedema are given in Table 2.
Very slight erythema was noted at all the treated skin sites one hour after patch removal with well defined erythema and very slight to slight oedema at the 24, 48 and 72-hour observations. Very slight erythema was noted at all treated skin sites at the 7‑day observation. Light brown discolouration of the epidermis and loss of skin flexibility and elasticity were noted at all treated
skin sites at the 48 and 72‑hour observations. Crust formation was noted at all treated skin sites at the 7‑day observation.
All treated skin sites appeared normal at the 14-day observation.
Any other information on results incl. tables
Bodyweight:
Individual bodyweights and bodyweight changes are given in Table 3.
All animals showed expected gain in bodyweight during the study.
Table1 Individual Skin Reactions Following 3-Minute and 1-Hour Exposures
Skin Reaction |
Observation Time |
Individual Scores - Rabbit Number and Sex |
|
67625Male |
|||
3-Minute Exposure |
1-Hour Exposure |
||
Erythema/Eschar Formation |
1 Hour |
0 |
1 |
24 Hours |
2 |
2 |
|
48 Hours |
2LeBr |
2LeBr |
|
72 Hours |
1LeCf |
2LeLfBr |
|
7 Days |
0D |
0D* |
|
14 Days |
0 |
0 |
|
Oedema Formation |
1 Hour |
0 |
0 |
24 Hours |
1 |
1 |
|
48 Hours |
1 |
1 |
|
72 Hours |
1 |
1 |
|
7 Days |
0 |
0 |
|
14 Days |
0 |
0 |
D= Slight desquamation
D* = Moderate desquamation
Br = Light brown discolouration of the epidermis
Le = Loss of skin elasticity
Lf = Loss of skin flexibility
Cf = Crust formation
Table2 IndividualSkin ReactionsFollowing 4-Hour Exposure
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
||
67625Male |
67676Male |
67678Male |
|||
Erythema/Eschar Formation |
1 Hour |
1 |
1 |
1 |
(3 ) |
24 Hours |
2 |
2 |
2 |
6 |
|
48 Hours |
2BrLeLf |
2BrLeLf |
2BrLeLf |
( 6 ) |
|
72 Hours |
2BrLeLf |
2BrLeLf |
2BrLeLf |
6 |
|
7 Days |
1Cf |
1Cf |
1Cf |
( 3 ) |
|
14 Days |
0 |
0 |
0 |
( 0 ) |
|
Oedema Formation |
1 Hour |
0 |
0 |
0 |
( 0 ) |
24 Hours |
1 |
1 |
1 |
3 |
|
48 Hours |
2 |
2 |
2 |
( 6 ) |
|
72 Hours |
2 |
2 |
2 |
6 |
|
7 Days |
0 |
0 |
0 |
( 0 ) |
|
14 Days |
0 |
0 |
0 |
( 0 ) |
|
Sum of 24 and 72-hour Readings (S): 21 |
|||||
Primary Irritation Index (S/6) : 21/6 = 3.5 |
|||||
Classification : MODERATE IRRITANT |
( ) = Total values not used for calculation of primary irritation index
Cf = Crust formation
Br = Light brown discolouration of the epidermis
Le = Loss of skin elasticity
Lf = Loss of skin flexibility
Table3 Individual Bodyweights and Bodyweight Change
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 14 |
||
67625Male |
2.97 |
3.12 |
0.15 |
67676Male |
2.71 |
3.04 |
0.33 |
67678Male |
2.50 |
2.87 |
0.37 |
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information (but not classifed according to EC Regulation No. 1272/2008) Criteria used for interpretation of results: EU
- Conclusions:
- In a skin irritation test conducted according to OECD guideline 404 and GLP principles, no corrosive or irreversible effects were noted. The average erythema and oedema score at 24, 48 and 72 hours after exposure was 2 and 1.66 resp, therefore this substance is not classified for skin irritation according to EC Regulation No. 1272/2008. In accordance with EC Directive No. 67/548, the substance should be classified with Xi; R38.
Based on the results obtained in this study, the substance should be labelled with EUH066 – “Repeated exposure may cause skin dryness or cracking” - Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted)
§ Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC
Results. 3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema and slight oedema. Other skin reactions noted were light brown discolouration of the epidermis, loss of skin elasticity and flexibility and crust formation. All treated skin sites appeared normal at the 14-day observation. No corrosive effects were noted.
Conclusion:
No corrosive effects were noted. The average erythema and oedema score at 24, 48 and 72 hours after exposure was 2 and 1.66 resp, therefore this substance is not classified for skin irritation according to EC Regulation No. 1272/2008. In accordance with EC Directive No. 67/548, the substance should be classified with Xi; R38. Based on the results obtained in this study, the substance should be labelled with EUH066 – “Repeated exposure may cause skin dryness or cracking”
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