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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 310-079-6 | CAS number: 102242-48-8 The complex residue resulting from the vacuum distillation of C6-24 and C6-24 unsatd. fatty alcohols which is derived from hydrogenation of C6-24 and C6-24 unsatd. fatty acids methyl esters. It consists predominantly of satd. and unsatd. fatty alcohols having carbon numbers greater than C18, dimerization products, and long chain esters having carbon numbers greater than C32 and boils at > 250°C (482°F) at 10 torr.
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 21 - Nov 12 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The test was done before the implementation of the LLNA method.
Test material
- Reference substance name:
- Alcohols, C6-24 and C6-24-unsatd., distn. residues
- EC Number:
- 310-079-6
- EC Name:
- Alcohols, C6-24 and C6-24-unsatd., distn. residues
- Cas Number:
- 102242-48-8
- Molecular formula:
- Not available due to the complexity of the substance
- IUPAC Name:
- Alcohols, C6-24 and C6-24-unsatd. even numbered, distn. residues
- Details on test material:
- - Name of test material (as cited in study report): Pernil RU, Espum EGA 213
- Chemical designation: 18:1 fatty alkohol, unsaturated, distillation residue
- Physical state: brown liquid
- Analytical purity: 100%
- Lot/batch No.: Charge of laboratory, no batch number given
- Expiration date: December 31, 1995
- Stability: yes
- Storage: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain as cited in study report: Pirbright white, Hsd/Win:DH
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: ca. 7 weeks
- Weight at study initiation: ca. 310 g
- Housing: groups of 2 - 3 animals per cage, Makrolon Type IV cages with standard softwood bedding
- Diet: pelleted Altromin Maintenance Diet 3022 (Fa. Altromin GmbH, Lage, Germany) ad libitum and carrots
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12
- Music was offered during light hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Remarks:
- oleum arachidis DAB 10
- Concentration / amount:
- Preliminary test series:
6, 12.5, 25, 50, 75, 100%
Main test, induction: 50%
Dose finding for maximal non-irritating concentration suitable for challenge: 20, 30 and 40%
Main test, challenge: 10 and 20%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Remarks:
- oleum arachidis DAB 10
- Concentration / amount:
- Preliminary test series:
6, 12.5, 25, 50, 75, 100%
Main test, induction: 50%
Dose finding for maximal non-irritating concentration suitable for challenge: 20, 30 and 40%
Main test, challenge: 10 and 20%
- No. of animals per dose:
- Treated group: 20
Control group: 10 - Details on study design:
- RANGE FINDING
Prior to testing for sensitisation, a preliminary test series was conducted for primary irritation of the test item and determination of the suitable concentration for induction. An amount of 0.5 mL of test solution was applied on the left flank for the concentrations ranging from 6 to 50% and on the right flank of each of 3 animals, for the concentrations ranging from 50 to 100%. Vehicle also was applied on each flank side. The exposure was terminated after 6 hours, by removing the dressing and cleaning the skin from residues. Based on the results of the preliminary test series, 50% was retained as test concentration for induction.
MAIN STUDY
The sensitisation test followed the procedure described by Buehler (Arch. Dermatol. 91: 171-175, 1965).
- INDUCTION
The hair of the flanks each test animal was removed by clipping. An amount of 0.5 mL of a 50% test solution was applied onto the left cranial clipped flank of each of the 20 animals of the treated group; the vehicle was applied similarly onto the flank of each of the 15 control animals. The application site was covered with an occlusive dressing for 6 hours. The application was repeated 3 times, once a week. Following the third induction, skin reaction was assessed after 1 and 24 hours.
- DOSE FINDING FOR CHALLENGE
Five animals of the control group which had already been treated with the vehicle were topically treated with 0.5 mL of 20, 30 and 40% test solution, applied onto the skin of the right flank. Exposure conditions were as already described (occlusive, 6 hours). After 24 and 48 hours following removal of the dressing, the skin was assessed signs of irritation. Based on the results of this test, 10 and 20% were selected as maximally non-irritating concentrations suitable for challenge.
- CHALLENGE EXPOSURE
Challenge was conducted after 14 days following the last induction. Similar as for induction, an amount of 0.5 mL of test material was applied onto an untreated clipped skin area of the flanks under occlusive conditions for 6 hours; both test concentrations, 10 and 20%, were applied bilaterally on the flanks of each animal of the treated group and the control group. After removal of the dressing, the skin was examined for reaction indicating sensitisation after 24, 48 and 72 hours.
EVALUATION OF SKIN REACTION
The skin reaction was scored according to the following grades:
- No reaction -> 0
- Weak erythema and/or edema -> 1
- Moderate erythema and/or edema -> 2
- Strong erythema and/or edema -> 3
EVALUATION CRITERIA
Subtracting the percentage of animals exhibiting dermal effects in the control group from the percentage of positive substance group animals gives the potential of test substance to cause skin sensitisation. A result of at least 15% of animals of the treatment group with dermal effects in a non-adjuvant-test characterizes the test substance as a sensitiser.
CHECK FOR MORTALITY AND BOY WEIGHT
All animals were observed for mortality and body weight gain was recorded.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 50%, challenge: 20%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- following first challenge, up to 80% of the animals of the treatment group showed weak to moderate skin reactions.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 50%, challenge: 20%. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: following first challenge, up to 80% of the animals of the treatment group showed weak to moderate skin reactions..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: vehicle only, challenge: 20%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- following first challenge, up to 70% of the animals of the control group showed weak to moderate skin reactions.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: vehicle only, challenge: 20%. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: following first challenge, up to 70% of the animals of the control group showed weak to moderate skin reactions..
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 50%, challenge: 10%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- following rechallenge, up to 20% of the animals of the treatment group almost showed weak skin reactions (in one case, reaction was assessed as moderate).
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 50%, challenge: 10%. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: following rechallenge, up to 20% of the animals of the treatment group almost showed weak skin reactions (in one case, reaction was assessed as moderate)..
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: vehicle only, challenge: 10%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- following rechallenge, up to 30% of the animals of the control group showed weak skin reactions.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: vehicle only, challenge: 10%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: following rechallenge, up to 30% of the animals of the control group showed weak skin reactions..
Any other information on results incl. tables
INDUCTION
After 1 hour following removal of the dressing, skin examination revealed one case of weak skin reaction graded 1 in the control group (1/15 animals) whereas in the treated group 9/20 animals displayed weak signs of skin irritation graded 1 and 2/20 had moderate signs graded 2. After 24 hours, all 15 control animals were free of skin findings whereas in the treated group, 7/20 and 3/20 animals still showed weak and moderate skin reaction, respectively.
CHALLENGE (20% test item)
Skin reactions seen after 24, 48 and 72 hours following removal of the dressing are summarised in the following table:
Overview of skin reaction after challenge with 20% test item in vehicle |
||||||||||||
Reading Time point |
24 hours after challenge |
48 hours after challenge |
72 hours after challenge |
|||||||||
Group |
Control (N=10) |
Treated (N=20) |
Control (N=10) |
Treated (N=20) |
Control (N=10) |
Treated (N=20) |
||||||
Flank region |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
No reaction |
9 |
5 |
20 |
15 |
8 |
3 |
16 |
4 |
10 |
7 |
19 |
15 |
Weak reaction |
1 |
5 |
0 |
5 |
2 |
6 |
4 |
12 |
0 |
3 |
1 |
4 |
Moderate reaction |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
4 |
0 |
0 |
0 |
1 |
Strong reaction |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
RECHALLENGE (10% test item)
Skin reactions seen after 24, 48 and 72 hours following removal of the dressing are summarized in the following table:
Overview of skin reaction after rechallenge with 10% test item in vehicle |
||||||||||||
Reading Time point |
24 hours after challenge |
48 hours after challenge |
72 hours after challenge |
|||||||||
Group |
Control (N=10) |
Treated (N=20) |
Control (N=10) |
Treated (N=20) |
Control (N=10) |
Treated (N=20) |
||||||
Flank region |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
No reaction |
10 |
7 |
20 |
16 |
10 |
7 |
20 |
16 |
10 |
10 |
20 |
19 |
Weak reaction |
0 |
3 |
0 |
4 |
0 |
3 |
0 |
3 |
0 |
0 |
0 |
1 |
Moderate reaction |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
Strong reaction |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CLINICAL PARAMETERS
No mortality occurred. Body weight gain in the treated group was similar to that in the control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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.