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EC number: 939-605-8 | CAS number: 68152-93-2
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Repeated dose toxicity
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- Specific investigations
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- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- 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
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
- Reference Type:
- publication
- Title:
- Skin sensitization and possible groupings for "read across" for rosin based substances
- Author:
- Illing, HPA, Malmfors, T and Rodenburg, L
- Year:
- 2 009
- Bibliographic source:
- Regulatory Toxicology and Pharmacology, 54(3): 234-241
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
- IUPAC Name:
- Rosin, fumarated
- Reference substance name:
- 65997-04-8
- Cas Number:
- 65997-04-8
- IUPAC Name:
- 65997-04-8
- Reference substance name:
- Rosin, fumarated
- EC Number:
- 266-040-8
- EC Name:
- Rosin, fumarated
- IUPAC Name:
- 266-040-8
- 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
Constituent 2
Constituent 3
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 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19-25- Humidity (%): 30-70- Air changes (per hr): approximately 15- Photoperiod (hrs dark / hrs light): 12/12IN-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 STUDYANIMAL ASSIGNMENT AND TREATMENT- Name of test method: pooled- Criteria used to consider a positive response: SI>=3TREATMENT 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% : 1.25% : 7.050%: 12.8EC3 = 1.9%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 0%- 9608.38; 0.5% - 11105.25; 5%- 67485.31; 50%- 123379.8Dpm/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 informationCriteria used for interpretation of results: EU
- Conclusions:
- Under the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) guidelines, as well as the OECD 429 test guidelines a EC3 ≥ 3 value is required to consider a substance as positive when testing using the LLNA method. Results from this study indicated that rosin, fumarated topically administered to mice at 0.5, 5, and 50% w/v in acetone/olive oil 4:1 resulted in a pooled Stimulation Index of 1.2, 7.0, and 12.8, respectively. Based on the results of this study, rosin, fumarated is classifiable for skin sensitization according to UN Globally Harmonized System of Classification or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
- Executive summary:
In a skin sensitization study using the Local Lymph Node Assay, groups of mice were given daily applications of 0%, 0.5%, 5%, or 50%(w/v)rosin, fumaratedin in acetone/olive oil 4:1 which was applied to the dorsal surface of each ear for 3 consecutive days. A control group received the vehicle only in the same manner. On Day 5, 3HTdR was injected into the tail vein, the auricular lymph nodes collected 5 hr later, and a single cell suspension prepared. 3HTdR incorporation by the cells was determined, and the Stimulation Index (SI) calculated for each dose of the test substance. The pooled Stimulation Index was 1.2, 7.0, and 12.8, respectively. Based on the results, rosin, fumaratedwas a skin sensitizer in mice in an OECD 429 compliant study.
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