Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-525-2 | CAS number: 96-69-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Immunotoxicity
Administrative data
- Endpoint:
- immunotoxicity: oral
- Remarks:
- other: immunotoxicological evaluation
- Type of information:
- other: publication
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The evaluation of the study is hampered by lacking information concerning the Guidelines for testing and the quality of the tested substance. Moreover, the study does not investigate concomitant effects of mortality or clinical toxicology.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female rats were treated with 0, 10, 100, 200 mg/kg bw radiolabelled 4,4'-thiobis(6-tert-butyl-3-cresol) once daily for 14 consecutive days. After 14 days the immunological response was investigated.
- GLP compliance:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): TBBC
No further information mentioned in publication.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CB6F1
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Litton Bionetics Inc.
- Age at study initiation: 5 -6 weeks
- Weight at study initiation: 17 - 20 g
- Fasting period before study: not mentioned
- Housing: four animals together in plastic shoebox cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 40 - 60
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 100, 200 mg/kg bw
Basis:
no data
- No. of animals per sex per dose:
- 5 - 8
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and clinical examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
OTHER:
Detailed analysis of various cell types involved in immunology.
Results and discussion
Results of examinations
- Clinical signs:
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Gross pathological findings:
- not examined
- Details on results:
- All immunological parameters were measured 24 hr after the last chemical exposure. When indicated, animals were immunized during the exposure.
TBBC produced a decrease in the peak IgM (44%) and peak IgG (48%) antibody response to sheep erythrocytes (SRBCs), but had no effect on the delayed hypersensitivity response (DHR) to keyhole limpet hemocyanin (KLH).
Paradoxically, TBBC caused an overall increase in the number of splenic cells, a decrease in the percentage of splenic T cells and no effect on the percentage of splenic B cells.
There were no effects on the lymphoproliferative responses to optimal concentrations of concanavalin A(Con A), phytohemagglutinin (PHA), and lipopolysaccharide (LPS), but there was a significant decrease in the mixed lymphocyte response (MLR).
In both the mitogen assays and the MLR there was a dose-related increase in the basal (unstimulated) DNA synthesis of the spleen celIs. Innate immunity, as measured by natural killer (NK) celI activity and serum complement, was significantly increased.
Effects on macrophage function were complex, as an increase or no effect was observed depending on the parameter measured. In the host resistance models, animals were infected with various pathogens 24 hr after the last chemical exposure. Exposure to TBBC caused an increased resistance to challenge with Streptococcus and B16F10 melanoma, a decreased resistance to challenge with PYB6 tumors, and no effect on the resistance to HSV-2, Listeria or Plasmodium.
Specific immunotoxic examinations
- Cell viabilities:
- effects observed, treatment-related
- Humoral immunity examinations:
- effects observed, treatment-related
- Specific cell-mediated immunity:
- effects observed, treatment-related
- Non-specific cell-mediated immunity:
- effects observed, treatment-related
- Other findings:
- effects observed, treatment-related
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- Upon treatment of female rats with 0, 10, 100, 200 mg/kg bw radiolabelled 4,4'-thiobis(6-tert-butyl-3-cresol) once daily for 14 consecutive days, the animals expressed complex imunological toxicity effects from 10 mg-kg bw onwards.
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.
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