Registration Dossier
Registration Dossier
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: 700-751-0 | CAS number: -
- 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:
- October 16 to 22, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to guideline
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Rosin, fumarated
- EC Number:
- 266-040-8
- EC Name:
- Rosin, fumarated
- Cas Number:
- 65997-04-8
- IUPAC Name:
- Rosin, fumarated
- Details on test material:
- - Name of test material (as cited in study report): (Phenolic) reaction product of rosin with fumarate (ex raisio) fumarised for 1 hour. (The inclusion of the word phenolic in the study report totle was incorrect)
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Reaction product derived from UVCB
- Physical state: amber coloured solid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material: deep frozen at -18C in the dark
- Other:
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 Limited, Bicester, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: Individually in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): ad libitum (Certified rat and mouse diet - Code 5LF2- supplied by International Product Supplies Ltd, Northants, UK)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 October 2002 To: 22 October 2002
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 0.5, 5, 50% w/v
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS: None conducted. Information available suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: pooled
- Criteria used to consider a positive response: SI>=3
TREATMENT PREPARATION AND ADMINISTRATION:
See further details under 'Any other information on materials and methods inc. tables'.
The method used was that described by;
Kimber et al, 1989. The murine local lymph node assay for identification of contact allergens: a preliminary evaluation of in situ measurements of lymphocyte proliferation. Contact Dermatitis 21, 215-220.
Basketter and Scholes, 1992. Comparison of the local lymph node assay with the guinea pig maximisation test for the detection of a range of contact allergens. Food and Chemical Toxicology 30, 65-69. - Positive control substance(s):
- other: historical positive control data
- Statistics:
- no data
Results and discussion
- Positive control results:
- See table 1 within 'Any other information on results inc. tables' for summary of positive control data for the LLNA in the testing laboratory
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 0.5% : 1.2 5% : 7.0 50%: 12.8
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 0%- 9608.38; 0.5% - 11105.25; 5%- 67485.31; 50%- 123379.8 Dpm/node (obtained dividing the dpm value by 8 - total number of lymph nodes): 1201.0, 1388.2, 8435.7, 15422.5, respectively.
Any other information on results incl. tables
There were no clinical signs of toxicity or mortality.
Bodyweight changes of the test animals between Day 0 and Day 5 were comparable to those observed in the corresponding control group animals over the same period.
Table 1. Summary of Positive Control Data for the Local Lymph Node Assay for the testing laboratory
Project number |
Start date |
Finish date |
Test material |
Concentration % (w/v) |
Vehicle |
Stimulation Index |
Classification |
039/516 |
22/08/01 |
28/08/01 |
4-Ethoxymethylene-2-phenyl-2-oxazolin-5-one |
0.10, 0.25, 0.50 |
4:1 acetone/olive oil |
14.01, 57.28, 42.18 |
Positive |
039/520 |
12/12/01 |
18/12/01 |
Penicillin G Sodium Salt |
10, 25, 50 |
Dimethyl Formamide |
1.7, 4.1, 4.0 |
Positive |
039/522 |
23/01/02 |
29/01/02 |
Polyoxyethylenesorbitan monooleate |
0.25, 2.5, 25 |
4:1 acetone/olive oil |
1.22, 2.90, 4.33 |
Positive |
0.39/524 |
06/03/02 |
12/03/02 |
Eugenol |
5, 25, 50 |
4:1 acetone/olive oil |
1.7, 9.9, 0.2 |
Positive |
039/525 |
07/03/02 |
13/03/02 |
Cobalt Chloride Hexahydrate |
0.005, 0.05, 0.5 |
Dimethyl Formamide |
0.7, 1.4, 6.2 |
Positive |
039/586 |
13/08/02 |
19/08/02 |
Alpha-hexylcinnamaldehyde |
5, 10, 50 |
4:1 acetone/olive oil |
5.7, 5.5, 33.5 |
Positive |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be a sensitiser under the conditions of the test.
- Executive summary:
This is a Local Lymph Node Assay conducted following the OECD guideline. Rosin fumarated was administered topically to mice at 0.5, 5, and 50% w/v in acetone/olive oil 4:1 and the pooled Stimulation Index was 1.2, 7.0, and 12.8, respectively. The test substance is considered to be a sensitiser under the conditions of this study.
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.
