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EC number: 417-060-2 | CAS number: 151006-61-0 1-DODECENE DIMER, HYDROGENATED; ALKANE 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 November 1994 and 5 November 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The work described was performed in compliance with the UK Principles of Good Laboratory Practice (The united Kingdom Compliance Programme. Department of Health 1989)
Test material
- Reference substance name:
- A mixture of isomers of branched tetracosane
- EC Number:
- 417-060-2
- EC Name:
- A mixture of isomers of branched tetracosane
- Cas Number:
- 151006-61-0
- Molecular formula:
- C24 H50
- IUPAC Name:
- A mixture of isomers of branched tetracosane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rabbits were supplied by David Percival Ltd. Moston. Sandbach. Cheshire. UK.
- Age at study initiation: Twelve to twenty weeks old
- Weight at study initiation: Animals weighed 2.23 to 2.51kg and were approximately twelve to twenty weeeks old.
- Housing:Animals were individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Free access to mains drinking water and food (STANRAB SQC Rabbit Diet. Special Diets Services Ltd. Witham. Essex. UK) was allowed throughout the study.
- Water (e.g. ad libitum):Free access to mains drinking water and food (STANRAB SQC Rabbit Diet. Special Diets Services Ltd. Witham. Essex. UK) was allowed throughout the study.
- Acclimation period: Seven days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Animal room maintained a temperature of 17 to 20°C.
- Humidity (%): 58 to 65%
- Air changes (per hr): Rate of air exchange was approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light):Lighting controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
IN-LIFE DATES: From: Day 0 To: Day 3
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: A contralateral area of untreated skin was identified on each rabbit to serve as the control against which the reactions of the untreated site were evaluated.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A quantity of 0.5ml of the test material was introduced under a 2.5cm x 2.5cm cotton gauze patch.
- Concentration (if solution):No Data
VEHICLE
- Amount(s) applied (volume or weight with unit):Not applicable
- Concentration (if solution):Not applicable
- Lot/batch no. (if required): Not applicable
- Purity:Not applicable - Duration of treatment / exposure:
- 4 Hours
- Observation period:
- Thirty minutes following the removal of the patches and approximately 24, 48 and 72 hours after patch removal, the test sites were examined for evidence of primary irritation and scored.
- Number of animals:
- 6 Rabbits
- Details on study design:
- TEST SITE
- Area of exposure: The back of each rabbit.
- % coverage: 2.5cm by 2.5cm cotton gauze patch.
- Type of wrap if used: 2.5cm by 2.5cm cotton gauze patch and placed in position with a strip of porous tape ( Micropore surgical tape, 3M Health care, Loughborough, England)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits. The control sites were similarly swabbed.
- Time after start of exposure: 4 hours.
SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation
Value
No erythema.............................................................................0
Very slight erythema (barely perceptible)........................... 1
Well-defined erythema.............................................................2
Moderate to severe erythema.................................................3
Severe erythema (beef redness) to eschar formation preventing grading of erythema...4
Oedema Formation
Value
No oedema..................................................0
Very slight oedema (barely perceptible).......................1
Slight oedema (edges of area well-defined by definite raising)..................2
Moderate oedema (raised approximately 1 millimetre)................................3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)...........4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.25
- Reversibility:
- no data
- Remarks on result:
- other: No corrosive effects were noted.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.1
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Score:
- 0
- Reversibility:
- no data
- Irritant / corrosive response data:
- Please see attached tables 1-3.
- Other effects:
- Not applicable.
Any other information on results incl. tables
EVALUATION OF SKIN REACTIONS |
|
Erythema and Eschar Formation |
Value |
No erythema.................................................................................................................... |
0 |
Very slight erythema (barely perceptible).......................................................................... |
1 |
Well-defined erythema..................................................................................................... |
2 |
Moderate to severe erythema........................................................................................... |
3 |
Severe erythema (beef redness) to eschar formation preventing grading of erythema.......... |
4 |
Oedema Formation |
Value |
No oedema..................................................................................................................... |
0 |
Very slight oedema (barely perceptible)............................................................................ |
1 |
Slight oedema (edges of area well-defined by definite raising)............................................ |
2 |
Moderate oedema (raised approximately 1 millimetre)...................................................... |
3 |
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)....................................................................................................................................... |
4 |
Any other skin reactions, if present, were also recorded.
Calculation of Primary Irritation Index. (FIFRA Data Reporting Guidelines)
The values for erythema and oedema for each animal at the 30 minute, 24, 48 and 72 -hour readings were totalled for the six test rabbits and each total was divided by 4 to give a score for each animal. The total of these scores was divided by 6 to give the primary irritation index of the test material.
Calculation of scores according to Annex VI of Council Directive 67/548/EEC. Relating to the classification, Packaging and Labelling of Dangerous Substances.
The values for erythema and oedema for each animal at the 24, 48 and 72 hour readings were totalled for the six test animals and the total scores divided by 18 to give a mean value for erythema and a mean value for oedema.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material. Alkane 2. produced a primary irritation index of 0.25 calculated according to FIFRA data reporting guidelines. No corrosive effects were noted. The test material produced mean scores of 0.1 for erythema/eschar formation and 0.0 for oedema according to EC labelling regulations.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.
The study was designed to comply with the requirements of the U.S. Environmental Protection Agency (EPA) Guidelines, the OECD Guidelines for testing of chemicals No.404 "Acute Dermal Irritation/ Corrosion" .
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by commission Directive 93/21/EEC).
A single 4 -hour, semi-occluded application of the test material to the intact skin of six rabbits produced very slight erythema at four treated skin sites 30 minutes after patch removal. Very slight erythema persisted at two treated skin sites at the 24 -hour observation. All treated skin sites appeared normal at the 48 -hour observation.
The test material produced mean scores of 0.1 for erythema/eschar formation and 0.0 for oedema according to EC labelling regulations.
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