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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 232-458-4 | CAS number: 8046-19-3 Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Liquidambar styraciflua, Hamamelidaceae).
- 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:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Kligman, A. M. (1966). "The identification of contact allergens by human assay. III. The maximization test: a procedure for screening and rating contact sensitizers". J. Invest. Dermatol. 47: 393–409.
- GLP compliance:
- no
- Specific details on test material used for the study:
- TEST MATERIAL
STYRAX ALC. SOL. TURKISH IN DEP. 78-8-8283 - Species:
- other: human
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Details on test animals and environmental conditions 29 healthy male and female volunteers were screened and 25 completed the study.
Age 20 - 69
Gender: 10 males, 15 females - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: petrolatum
- Amount / concentration applied:
- 8%
- Duration of treatment / exposure:
- 48 hours
- Number of animals:
- 25
- Details on study design:
- In a pre-test for a human maximization study, a patch of the test material in petrolatum was applied to normal sites on the backs of 25 healthy male and female volunteers for 48 hours under occlusion. The skin irritation of Styrax alcohol soluble Turkish in DEP in a concentration of 8% was evaluated prior to a human maximization test and to determine whether sodium lauryl sulfate pretreatment was necessary.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- <= 0
- Reversibility:
- other: not relevant
- Remarks on result:
- no indication of irritation
- Remarks:
- Styrax alcohol soluble Turkish in DEP in a concentration of 8%
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- <= 0
- Reversibility:
- other: not relevant
- Remarks on result:
- no indication of irritation
- Remarks:
- Styrax alcohol soluble Turkish in DEP in a concentration of 8%
- Irritant / corrosive response data:
- No skin irritation observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 8% Styrax alcohol soluble Turkish in DEP was not irritating to human skin under the conditions of this test.
- Executive summary:
In a pre-test for a human maximization study, a patch of the test material in petrolatum was applied to normal sites on the backs of 25 healthy male and female volunteers for 48 hours under occlusion. The skin irritation of Styrax alcohol soluble Turkish in DEP in a concentration of 8% was evaluated prior to a human maximization test and to determine whether sodium lauryl sulfate pretreatment was necessary. No skin irritation observed. 8% Styrax alcohol soluble Turkish in DEP was not irritating to human skin under the conditions of this test.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Kligman, A. M. (1966). "The identification of contact allergens by human assay. III. The maximization test: a procedure for screening and rating contact sensitizers". J. Invest. Dermatol. 47: 393–409.
- GLP compliance:
- no
- Type of study:
- other: Human maximisation test
- Justification for non-LLNA method:
- The study was conducted before REACH came into force and before OECD test guideline 429 was published.
Test material
- Reference substance name:
- Storax (balsam)
- EC Number:
- 232-458-4
- EC Name:
- Storax (balsam)
- Cas Number:
- 8046-19-3
- Molecular formula:
- Not applicable, UVCB - NCS
- IUPAC Name:
- Storax (balsam)
- Test material form:
- liquid
- Details on test material:
- CAS 8046-19-3
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Styrax resinoid oil, Styrax oil, Styrax, Storax oil, Storax
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL
STYRAX ALC. SOL. TURKISH IN DEP. 78-8-8283
In vivo test system
Test animals
- Species:
- other: human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 29 healthy male and female volunteers were screened and 25 completed the study.
Age 20 - 69
Gender: 10 males, 15 females
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- for 5 alternate day 48 hour periods
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: Challenge site was not pretreated
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: Challenge site was pretreated with 2% sodium lauryl sulfate
- No. of animals per dose:
- 25 volunteers completed the study
- Details on study design:
- The materials were presented on all subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-treated with 5% SLS.
The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 5% aqueous SLS under occlusion for the initial patch only.
Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 2% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5.
Patch material: Webril cloth
Induction patch 1,5 inch square with 1.0 mL test solution
Challenge patch 1,0 inch square with 0.4 mL test solution - Challenge controls:
- SLS controls were placed on the left and petrolatum on the right and labeled site 5.
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 8%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- The test material produced one irritant reaction in subject #22
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- not applicable
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No significant reactions were seen except in one subject, the site appeared irritated. It can be concluded that STYRAX ALC. SOL. TURKISH IN DEP. produced one irritant reaction.
- Executive summary:
A Human maximisation test was performed according to the Kligman, 1966 procedure. 29 healthy male and female volunteers were screened and 25 completed the study. The materials were presented on all subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-treated with 5% SLS. The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 5% aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 2% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right. No significant reactions were seen except in one subject, the site appeared irritated. It can be concluded that STYRAX ALC. SOL. TURKISH IN DEP. produced one irritant reaction.
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.