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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 424-970-3 | 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 May 1999 - 28 May 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 30 September 1996
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed before alternative methods were available.
Test material
- Reference substance name:
- -
- EC Number:
- 424-970-3
- EC Name:
- -
- Cas Number:
- 166255-23-8
- Molecular formula:
- C16-H14-O3.C6-H16-O3-Si
- IUPAC Name:
- Triethoxysilylpropyl Dibenzoyl Resorcinol
- Test material form:
- solid
- Details on test material:
- Appearance: light yellow solid lumps (2-3 cm)
Constituent 1
- Specific details on test material used for the study:
- Storage: at ambient temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Crl:(HA)BR
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Microbiological status of animals, when known: SPF
- Age at study initiation: circa 3 weeks
- Weight at study initiation: 223-457g
- Housing: maximal 10 animals per cage
- Diet: standard laboratory diet (SDS Special Diets services, Whitham, England), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55-79
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 4 May 1999 To: 28 May 1999
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- maize oil
- Concentration / amount:
- 3%
- Route:
- epicutaneous, open
- Vehicle:
- maize oil
- Concentration / amount:
- 30% (pretreatment with 10% SLS)
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- maize oil
- Concentration / amount:
- 10%
- Day(s)/duration:
- 14 days after last induction
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- maize oil
- Concentration / amount:
- 30%
- Day(s)/duration:
- 14 days after last induction
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS:
The response to intradermal treatment was examined in animals, that were treated with 3%, 1%, 0.3% and 0.1% of SDBR in maize oil. A sufficiently large area of the flanks was clipped free from hair and amounts of 0.1 mL of the concentrations were applied by intradermal injection.
The irritation response to topical treatment of various concentrations of the test item (1%, 3%, 10% and 30%) was examined in 2 other guinea pigs. The test item was brought into contact with the clipped skin and covered with a piece of hypoallergenic paper. The dressing was left in place for ca. 24 hours. Circa 24 and 48 hours after removal of the dressing, the skin was examined.
MAIN STUDY
A. INDUCTION EXPOSURE
Induction was achieved by an intradermal injection and one week later by topical application over the injection site.
For the intradermal injections an area of about 24cm2 of dorsal skin in the scapular region was clipped free from hair. Pairs of intradermal injections (0.1 mL each) were made simultaneously.
The following preparations were injected:
Test animals: two injections with Freund's Complete Adjuvant (FCA) and saline (1:1), two injections with SDBR solution and two injections with SDBR solution in FCA/diluent (1:1);
Control animals: two injections with FCA/ saline (1:1), two injections with the diluent and two injections with FCA/diluent (1:1).
Skin readings were made at ca. 24 hours after the treatment.
Six days after the intradermal injections, the dorsal skin in the scapular region of all test and control animals was closely clipped again, and subsequently treated with a 10% dilution of sodium lauryl sulfate in vaseline (open application). On the following day, the induction by topical application was made in this region. A circa 2x4 cm patch of Whatman No.3 MM filter was loaded with the selected concentration of the test substance. The loaded patch was placed over the sites of the intradermal injections and was secured in place for ca. 48 hours. The control animals were similarly treated with the vehicle only. Skin readings were made directly after removal of the patches.
B. CHALLENGE EXPOSURE
The topical challenge was carried out 14 days after the topical induction. An area of ca. 5x5 cm on the right and left flank of each test and control animal was clipped free from hair. Patches were loaded with the two test concentrations selected or with the vehicle alone. Subsequently, two patches loaded with the two test concentrations (10% and 30%) were placed on the clipped area of the right flank of each test and control animal and the patch loaded with the vehicle on the left flank. The patches were covered with Leukopor bandage, and held in place by Tensoplast for ca. 24 hours. Skin readings were made at ca. 24 and 48 hours after removal of the patches. - Positive control substance(s):
- yes
- Remarks:
- A study with a positive control substance was performed in April 1999 (not as a part of this study).
Results and discussion
- Positive control results:
- The sensitivity of the test system was checked by means of a positive control study with formaldehyde (37%). This study was performed in April 1999 (results included in the study report).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Preliminary test:
The degree of irritation observed after intradermal treatment with the 3% test concentration was considered suitable for intradermal treatment during unduction phase. A concentration higher than 3 % could not be injected by syringe.
A 30% concenctration was considered acceptable for topical treatment during the induction and challenge phase. A concentration above 30% was considered not feasible, as it was expected to form a very tough and dry paste. Since the 30% test concentration was not irritating, the induction site was pretretaed with 10% SLS in vaseline. In addition a 10% test concentration was also examined during challenge, because of an incidental slight erythema observed during the preliminary test.
Signs of irritation during induction:
After topical application of the vehicle alone, slight erythema was generally observed in the controls. After the 48-hours topical application of the selected test
concentration, slight erythema was also generally observed in the test animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of a guinea pig maximization test performed according to OECD/EC guidelines and under GLP principles, SDBR is concluded not to be a skin sensitizer.
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.