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EC number: 701-057-0 | CAS number: 2156595-41-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in a GLP facility to OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (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:
- Hydrogenated rosin alcohols
- EC Number:
- 701-057-0
- Cas Number:
- 2156595-41-2
- IUPAC Name:
- Hydrogenated rosin alcohols
- Test material form:
- liquid: viscous
- Details on test material:
- Identity: Abitol-E
Batch No.: CM-006
Aggregate state at room temperature: Liquid
*Colour: Colourless
Composition: Hydroabietyl alcohol, 99%
Solubility in water: Poorly soluble to insoluble
Solubility in vehicle: Soluble in most orcanic/lipophillic materials
Stability in solvent: Not indicated by the sponsor
Storage: At room temperature (15 – 25°C)
Expiration Date: November 01, 2007
1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Test system: Mice, CBA/CaOlaHsd
Rationale: Recognised as the recommended test system
Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst / The Netherlands
Number of animals for the pre-test: 2 females
Number of animals for the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant) Number of test
Groups: 3
Number of control (vehicle) groups: 1
Age: 7 - 8 weeks (beginning of acclimatisation)
Identification: Single caging. The animals were distributed into the
test groups at random and identified by cage number.
Acclimatisation: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
The animals were kept conventionally. The experiment was conducted under standard laboratory conditions.
Housing: single
Cage Type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
Bedding: granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen)
Feed: pelleted standard diet, ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen)
Water: tap water, ad libitum, (Gemeindewerke, D-64380 Rossdorf)
Environment: temperature 22 + 3°C
relative humidity 30-78%
artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 and 50%
- No. of animals per dose:
- 4
- Details on study design:
- Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 10, 25, and 50 % (w/v) in acetone:olive oil (4+1). The application volume, 25 ul, was spread over the entire dorsal surface ( 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle
alone (control animals).
3H-methyl thymidine (3HTdR) was purchased from GE Healthcare (GE Healthcare product code no. TRA 310; specific activity, 2 Ci/mmol; concentration, 1 mCi/ml). Five days after the first topical application, all mice were administered with 250 ul of 80.7 uCi/ml 3HTdR (corresponds to 20.2 uCi 3HTdR per mouse) by intravenous injection via a tail vein.
Approximately five hours after treatment with 3HTdR all mice were euthanised by intraperitoneal injection of Ketamin/Xylazin/Midazolam (4+2+1).
The draining lymph nodes were rapidly excised and pooled per group (8 nodes per group). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 um mesh size). After washing two times with phosphate buffered saline (approx. 10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and
incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 ml) and transferred to plastic scintillation vials with 10 ml of ‘Ultima Gold’ scintillation liquid and thoroughly mixed.
The level of 3HTdR incorporation was then measured on a -scintillation counter. Similarly, background 3HTdR levels were also measured in two 1ml-aliquots of 5 % trichloroacetic acid. The -scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
A statistical analysis was conducted for assessment of the dose-response relationship, and the EC3
value was calculated according to the equation
EC3 = (a-c) [(3-d)/(b-d)] + c
where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in
draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the
co-ordinates of the two pair of data lying immediately above and below the S.I. value of
3 on the local lymph node assay dose response plot.
Results and discussion
- Positive control results:
- The positive control gave positive results
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.05
- Test group / Remarks:
- 10%
- Remarks on result:
- other: 2.05 @ 10%, 6.58 @ 25% and 9.76 @ 50%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 7837 @ 10%, 25142 @ 25% and 37308 @ 50%
- Parameter:
- SI
- Value:
- 6.58
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 9.76
- Test group / Remarks:
- 50%
Any other information on results incl. tables
Calculation and Results of Individual Data | ||||||
Vehicle: acetone:olive oil (4+1) | ||||||
Test item concentration % (w/v) |
Group | Measurement DPM |
Calculation | Result | ||
DPM-BGa) | number of lymph nodes | DPM per lymph node | S.I. | |||
--- | BG I | 24 | --- | --- | --- | --- |
--- | BG II | 24 | --- | --- | --- | --- |
--- | 1 | 3846 | 3822 | 8 | 477.8 | |
10 | 2 | 7861 | 7837 | 8 | 979.6 | 2.05 |
25 | 3 | 25166 | 25142 | 8 | 3142.8 | 6.58 |
50 | 4 | 37332 | 37308 | 8 | 4663.5 | 9.76 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate | ||||||
1 = Control Group | ||||||
2-4 = Test Group | ||||||
S.I. = Stimulation Index | ||||||
a) = The mean value was taken from the figures BG I and BG II | ||||||
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Executive summary:
In the study the test item Abitol-E dissolved in acetone:olive oil (4+1) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 10, 25, and 50 %. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 2.05, 6.58, and 9.76 were determined with the test item at concentrations of 10, 25 and 50 % in acetone:olive oil (4+1), respectively. The test item Abitol-E was found to be a skin sensitiser and an EC3 value of 13.1 % (w/v) was derived.
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