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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-250-5 | CAS number: 80-09-1
- 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:
- 2010-03-03 to 2010-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 24 Apri 2002
- Deviations:
- yes
- Remarks:
- Test conditions (the relative humidity in the animal room was between approximately 25 - 65 % for a few hours)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4,4'-sulphonyldiphenol
- EC Number:
- 201-250-5
- EC Name:
- 4,4'-sulphonyldiphenol
- Cas Number:
- 80-09-1
- Molecular formula:
- C12H10O4S
- IUPAC Name:
- 4,4'-sulfonyldiphenol
- Details on test material:
- - Name of test material (as cited in study report): DHDPS
- Analytical purity: 99.87 area%; dose calculation not adjusted purity
- Lot/batch No.: BB 1020
- Expiration date of the lot/batch: 2012
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 Laboratories B.V.; Postbus 6174; 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks (beginning of treatment)
- Weight at study initiation: 17.7 - 21.8 g
- Housing: single; Makrolon Type II, with wire mesh top (EHRET GmbH, 79302 Emmendingen, Germany)
- Diet (e.g. ad libitum): Pelleted standard diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimatisation: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 20-65%
- Photoperiod (hrs dark / hrs light): Artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 5, 10, and 25% (w/v)
- No. of animals per dose:
- 5 females (nulliparous and non-pregnant) per dose
- Details on study design:
- RANGE FINDING TESTS: a pre-test was performed in two animals
- Compound solubility: 10% or 25% by topical application
- Irritation: no signs of local irritation as confirmed by the ear thickness and ear weight measurements
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression. - Positive control substance(s):
- other: Alpha-Hexylcinnamaldehyde, tech. 85%
- Statistics:
- For all statistical calculations SigmaStat for Windows (Version 2.0) was used. A One-Way-Analysis-of-Variance was used as statistical method. In case of significant results of the One-Way-ANOVA, multiple comparisons were performed with the Dunnett test.
Results and discussion
- Positive control results:
- - Mean DPM per group (5 animals): 5918.7+/- 2521.5
- Stimulation Indices: 6.49
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.39
- Test group / Remarks:
- 5 % DHDPS
- Parameter:
- SI
- Value:
- 1.9
- Test group / Remarks:
- 10 % DHDPS
- Parameter:
- SI
- Value:
- 1.68
- Test group / Remarks:
- 25 % DHDPS
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: - 5% DHDPS: Mean DPM per group 661.1 +/-240.0 - 10% DHDPS: Mean DPM per group 904.1 +/- 205.0 - 25% DHDPS: Mean DPM per group 799.3 +/- 560.4
Any other information on results incl. tables
- No deaths occurred during the study period.
- No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item 4,4`-sulphonyldiphenol was not a skin sensitiser under the test conditions of this study.
- Executive summary:
The test item 4,4`-sulphonyldiphenol was tested in a Local Lymph Node Assay (LLNA) in mice according to OECD guideline 429 and EU method B.42. Three groups each of five female mice were treated with 5, 10 or 25% (w/v) test item concentration by topical application at the dorsum of each ear on three consecutive days. Two negative control groups were treated with the respective vehicle only (methyl ethyl ketone for the test item and acetone:olive oil (4+1) for the positive control item).
The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. Signs of local irritation (e.g. reddening of the ear skin, ear swelling) were also not observed during the study period. A statistically significant increase in ear weights was not observed in any of the groups treated with different concentrations of the test item in comparison to the vehicle control group.
Here, Stimulation Indices (S.I.) of 1.39, 1.90 and 1.68 were determined with the test item at concentrations of 5, 10 and 25% (w/v) in methyl ethyl ketone, respectively. A statistically significant difference in DPM/animal was not observed in any of the groups treated with different concentrations of the test item in comparison to the vehicle control group. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3. The S.I. of the positive control group was 6.49.
The test item 4,4`-sulphonyldiphenol did not show skin sensitizing potential in this assay 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.