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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 284-009-7 | CAS number: 84776-83-0
- 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)
- Remarks:
- In vivo study OECD 406
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Acceptable guinea pig maximisation test that followed sound scientific principles.
Test material
- Reference substance name:
- Resin acids and Rosin acids, esters with trimethylolpropane
- EC Number:
- 284-009-7
- EC Name:
- Resin acids and Rosin acids, esters with trimethylolpropane
- Cas Number:
- 84776-83-0
- Molecular formula:
- UVCB substance - Molecular formula Not applicable for UVCBs
- IUPAC Name:
- Resin acids and Rosin acids, esters with trimethylolpropane
- Test material form:
- solid
- Details on test material:
- Vapour pressure: less than 1.4 x 10-3 Pa at 25 °C
Water solubility: 0.06.09x10-4 kg/m-4 g/l
Density: 1.07 x10³ kg/m³ at 19.8 ∓ 0.5 °C
Appearance: pale yellow solid
Melting point: 24.2 to 51.2 ± 0.5 °C (297 to 324 ± 0.5 K)
Boiling point: 418 ± 0.5 °C (691 ± 0.5 K) at 100.9 kPa.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test material name: Ester of tall oil rosin
- CAS 84776-83-0
- Product Test Name: Bevilite 62-85
- Batch Number: 610496
- Appearance: Brittle sold
- Received: 20/05/1987
- Storage: Ambient temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Number of females: 40
- Identification: by ear tattoo
- Acclimation: performed in the lab - no additional details
- House: In suspended caged with wire mesh floors
- Water: Free access
- Diet: ad libitum - Vitamine C-enriched Guinea-Pig Diet F.D.1 (Special Diet Service Limited). Hay was given once weekly.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 7.5% w/w in piquid paraffin
- Day(s)/duration:
- 24, 48,72 %
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10% and 5% w/w in liquid paraffin
- Day(s)/duration:
- 24 hr
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20
- Details on study design:
- TEST ANIMALS:
Number: 20 (from Number 4300 to 4319)
PRELIMINARY INVESTIGATIONS
The intradermal and topical irritancy of a range of dilutions of ester of tall oil rosin was investigated to identify:
- irritant test substance concentrations suitable for the induction phase of the main study
- non – irritant concentrations by the topical route of administration for the challenge phase
The following concentrations of ester of tall oil rosin were selected:
- Induction:
*Intradermal injection: 7.5% w/w in liquid paraffin
*Topical application: 30% w/w in liquid paraffin
- Challenge
* 10% and 5% w/w in liquid paraffin
PROCEDURE
The method employed in this study for the detection of delayed contact hypersensitivity was the guinea-pif maximisation test described by B. Magnusson and A.M Kligman (1970) in “Allergic Contact Dermatitis in the Guinea-Pig: Identification of contact allergens”.
The procedure consists of 2 parts: Induction and challenge.
INDUCTION
A 4x6 cm area of dorsal skin on the scapular region of the guinea-pig was clipped free of air with electric clippers. Three pairs of intradermal injections were made simultaneously into this area.
1. Freund’s complete adjuvant was diluted with an equal volume of water for irrigation.
2. Ester of tall oil rosin, 7.5% w/w in liquid paraffin
3. Ester of tall oil rosin, 7.5% w/w in 50:50 mixture of Freund’s complete adjuvant and liquid paraffin.
TOTAL APPLICATION
One week after the injection, the same 4x6 cm intrascapular area was clipped and shaved free of hair.
A 2x4 cm patch of Whatman No. 3 paper was saturated with ester of tall oil rosin 30% w/w in liquid paraffin. The patch was placed on the skin and covered ny a length of impermeable plastic adhesive tape (5cm width “Blenderm”). This in turn was firmly secured by elastic adhesive bandage wound round the torso of the animal and fixed with impervious plastic adhesive tape. The dressing was left in place for 48 hr.
CONTROL ANIMALS
During the induction period the control animals were treated similarly to the test animals with exception that the test compound was omitted from the intradermal injections and topical application.
CHALLENGE
The test and control animals were challenged topically two weeks after the induction period using ester of tall oil rosin 10% and 5% w/w in liquid paraffin.
Hair was removed by clipping and the shaving from an area on the left flank of each guinea-pig. A 2x2 cm patch of Whatman N 3 was saturated with approximately 0.2 ml of ester of tall oil rosin 10% w/w in liquid paraffin and applied to an anterior site on the flank. The test material 5% w/w in liquid paraffin was applied in a similar manner to a posterior site. The patched were sealed to the flank for 24 hours under strips covered by Elastoplast would round the trunk and secured with Sleek.
READING CHALLENGE REACTION
The challenge sites were evaluated 24, 48 and 72 hours after removal of the patched.
Reactions were scored as follows:
- No erythema=0
- Slight erythema=1
- Well defined erythema-2
- Moderate erythema=3
- Severe erythema= to slight eschar formation (injuries and depth) =4
Oedema formation:
- No oedema= 0
- Slight oedema= 1
- Well defined oedema= 2
- Moderate oedema= 3
- Severe oedema= 4
INTERPRETATION OF THE RESULTS
Dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction at challenge was definitely more marked and/or persistent than the maximum reaction seen in animals of the control group.
If the dermal reaction seen in a test animal at challenge was slightly more marked and/or persistent than (but not clearly distinguishable from) the maximum reaction seen in the control animals, the results for that test was classified as inconclusive.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction resulting from the challenge application was the same as, or less marked and/or persistent than the maximum reaction seen in animals of the control group. - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% and 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Not reported
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% and 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Not reported
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% and 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Not reported
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Freund's treated controls
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- other: Not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals. The test material was not considered to have a sensitisation potential.
- Executive summary:
The intradermal and topical irritancy of a range of dilutions of ester of tall oil rosin was investigated to identify the irritant test substance concentrations suitable for the induction phase of the main study and the non – irritant concentrations by the topical route of administration for the challenge phase.
The method employed in this study for the detection of delayed contact hypersensitivity was the guinea-pig maximisation test described by B. Magnusson and A.M Kligman (1970) in “Allergic Contact Dermatitis in the Guinea-Pig: Identification of contact allergens”.
The procedure consisted of 2 parts: Induction and challenge.
A 4x6 cm area of dorsal skin on the scapular region of the guinea-pig was clipped free of air with electric clippers. Three pairs of intradermal injections were made simultaneously into this area.
1. Freund’s complete adjuvant was diluted with an equal volume of water for irrigation.
2. Ester of tall oil rosin, 7.5% w/w in liquid paraffin
3. Ester of tall oil rosin, 7.5% w/w in 50:50 mixture of Freund’s complete adjuvant and liquid paraffin.
One week after the injection, the same 4x6 cm intrascapular area was clipped and shaved free of hair.
A 2x4 cm patch of Whatman No. 3 paper was saturated with ester of tall oil rosin 30% w/w in liquid paraffin. The patch was placed on the skin and covered by a length of impermeable plastic adhesive tape (5cm width “Blenderm”). This in turn was firmly secured by elastic adhesive bandage wound round the torso of the animal and fixed with impervious plastic adhesive tape. The dressing was left in place for 48 hr.
During the induction period the control animals were treated similarly to the test animals with exception that the test compound was omitted from the intradermal injections and topical application.
The test and control animals were challenged topically two weeks after the induction period using ester of tall oil rosin 10% and 5% w/w in liquid paraffin.
Hair was removed by clipping and the shaving from an area on the left flank of each guinea-pig. A 2x2 cm patch of Whatman N 3 was saturated with approximately 0.2 ml of ester of tall oil rosin 10% w/w in liquid paraffin and applied to an anterior site on the flank. The test material 5% w/w in liquid paraffin was applied in a similar manner to a posterior site. The patched were sealed to the flank for 24 hours under strips covered by Elastoplast would round the trunk and secured with Sleek.
The challenge sites were evaluated 24, 48 and 72 hours after removal of the patched.
Based on the results of the study, the dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals. There was no evidence of delayed contact hypersensitivity seen in 18 animals.
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.