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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 purity of the tested substance; further the study is well documented and performed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- screening test
In Phase I and II the LD10 is determined. In Phase III pregnant female mice were administered the test substance during gestation for 10 days (gestation day 6-15). Effects on litter and parental animals were recorded. - GLP compliance:
- yes
Test material
- Details on test material:
- - Analytical purity: "the purest grade commercially available".
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- sex: female
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.
- Age at study initiation: 6-8 wks
- Housing: individually polycarbonate shoe box
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Extracted by acetonitrile and analyzed by HPLC. Recovery in phase I: 80 - 105%; in phase II: 93 - 106%; in phase III: 76-96%.
- Duration of treatment / exposure:
- Phase I: 5 days
Phase II: 12 days
Phase III: gestation day 6-15 - Frequency of treatment:
- Phase I: once daily for 5 days
Phase II and III: once daily for 10 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
10, 100, 1000 mg/kg bw/day
Basis:
actual ingested
Phase I
- Remarks:
- Doses / Concentrations:
0, 100, 310, 400, 500, and 630 mg/kg bw/day.
Basis:
actual ingested
Phase II repeated
- Remarks:
- Doses / Concentrations:
0, 485 mg/kg bw/day
Basis:
actual ingested
Phase III
- No. of animals per sex per dose:
- Phase I: three mice
Phase II: four mice
Phase III: 50 mice - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Other:
Phase I: range-finding study in non-pregnant mice dosing 5 days.
Phase II: because of the high mortality rate, a repeated Phase II was conducted with 100, 310, 400, 500, and 630 mg/kg bw/day, using pregnant mice dosing 10 days . Based on the mortality data, the predicted LD10 for 4,4'-thiobis(6-t-butyl-m-cresol) was 485 mg/kg bw/ day.
Phase III: 485 mg/kg bw/ day during 10 days.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: maternal moratlity and toxicity, twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: maternal body weights on days 6 - 15, 17 of gestation, and on day 0, 3 postpartum - Ovaries and uterine content:
- no data
- Fetal examinations:
- PARAMETERS EXAMINED
The following parameters were examined in [F1] offspring: number of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight when delivery was complete and on day 3. - Statistics:
- An overall test for homogeneity of variance (Bartlett's test and F-test) was performed on the weight data of each group following randomization. Average body weight per group and average body weight change per group were calculated for treatment and control groups. Pro bit analysis of mortality and morbidity data generated in Phase II of the range finding study was used to determine the predicted LD10 for the Phase III.
Phase III maternal data:
- Random weights: ANOVA (2-tail) (all groups, pregnant dams) (all groups, viable litters only)
- Survival: Fisher's Exact Test (one-tail) (each group vs control, all dams) (each group vs control, pregnant only)
- Weight gains: Mann-Whitney U-Test (2-tail) (each animal, day 6 to day 0 postnatal) (each group vs control; viable litters only)
- Proportion of viable litters Fisher's Exact Test (one-tail) (each group vs control, pregnant only)
- Survival of pups Chi-Square Test (one-tail) (each group vs control)
The Mann-Whitney U-test (2-tail) was used to compare each group to the concurrent control.
- Number live pups/litter (day 0, day 3)
- Length of gestation
- Average pup weight (day 0, day 3)
- Average wt. gain/litter (day 3 - day 0)
The p-value listed is not corrected for multiple comparisons.
14
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: increased mortality
Details on maternal toxic effects:
4,4'-Thiobis (6-t-butyl-m-cresol) caused an increased maternal mortality.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- other: LD10
- Effect level:
- 485 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes. Remark: decreased survival
Details on embryotoxic / teratogenic effects:
4,4'-Thiobis (6-t-butyl-m-cresol) caused a decreased percent survival of the pups while having no effect on the number of viable litters, the litter size, birth weight of the pups and weight gain of the pups.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- other: LD10
- Effect level:
- 485 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: 485 mg/kg bw/ day of 4,4'-thiobis (6-t-butyl-m-cresol) caused increases in rnaternal mortality and a decreased percent of pup survival while not affecting the number of viable litters, the litter size, birth weight or weight gain of the pups.
Fetal abnormalities
- Key result
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Phase I:
4,4 1 -Thiobis (6-t-butyl-m-cresol) did not produce chemical related ·mortality when administered at
dose levels of 10, 100, and 1000 mg/kg/day. Therefore, the dose levels for the Phase II selected
were 600, 1200, 2400, 4800, and 9600 mg/kg/day.
Phase II: Because of the high mortality rate, a repeated Phase II was conducted with 100, 310,
400, 500, and 630 mg/kg bw/day. Based on the mortality data, the predicted LD10 for 4,4'-thiobis
(6-t-butyl-m-cresol) was 485 mg/kg bw/ day.
Applicant's summary and conclusion
- Conclusions:
- In a screening study with female pregnant CD1 mice, the predicted median lethal dose for 4,4' -thiobis(6-t-butyl-m-cresol) was 485mg/kg/day. In addition, 485 mg/kg bw/ day of 4,4'-thiobis (6-t-butyl-m-cresol) caused increases in rnaternal mortality and a decreased percent of pup survival while not affecting the number of viable litters, the litter size, birth weight or weight gain of the pups.
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.
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