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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
Endpoint summary
Administrative data
Description of key information
4,4'-Thiobis(6-tert-butyl-3-cresol) was tested in albino rabbits for eye and skin irritation. The studies were not performed under GLP conditions or according to the current guidelines. However, the studies performed at Sunimoto were well performed and documented.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 28 - April 4, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although the study was quite old and not performed under GLP conditions, the described study method was comparable to OECD Guideline 404.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- not under GLP conditions, study dates 1986
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan Lab Animals Co., Ltd.
- Age at study initiation: not mentioned.
- Weight at study initiation: 2.05-2.47 kg
- Housing: individual metal mesh-bottomed suspenses cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 - 42 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 27
- Humidity (%): 45 - 75
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4.5, 24, 48, 72 hours and 1 week
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: lint clot with PBS plus surgical tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, gauze with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize criteria - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4.5 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: non wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: wounded test site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 week
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4.5 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: non wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4.5 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: (non) wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: non wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: wounded test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 week
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: (non) wounded test site
- Irritant / corrosive response data:
- 4.5 hours after the application of Slz WX-R, all of the cases (3 cases) showed erythema and edema in both the wounded site and the non-wounded site with a strength level of 1, at approximately the same extent for both findings. By 24 hours after application, the erythema had increased in intensity to a strength level of 2 in all of the cases, while the edema ranged in strength from 1 to 2. However, these local reactions gradually lessened, and by 1 week after application, all of the local reactions had disappeared.
The primary irritation rate that was calculated based on the above-noted results was 2.83, indicating that Slz WX-R will show moderate irritation of rabbit skin. - Other effects:
- none
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A study in 3 rabbits revealed that Slz WX-R 6 was moderately irritanting after 4-hour exposure. The study was not performed according to the general guidelines for acute dermal irritation/corrosion under GLP conditions, but was well performed and documented and as such considered reliable with minor restrictions.
Reference
none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 28 - April 4, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although the study was quite old and not performed under GLP conditions, the described study method was comparable to OECD Guideline 405.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- not under GLP conditions, study dates 1986
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Japan Lab Animals Co., Ltd.
- Age at study initiation: not mentioned.
- Weight at study initiation: 2.05-2.47 kg
- Housing: individual metal mesh-bottomed suspenses cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 - 42 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 27
- Humidity (%): 45 - 75
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1, 24, 48, 72, (96 hours, 1 week): with or without washing after 30 seconds for 1 minute
- Observation period (in vivo):
- 1, 24, 48, 72, (96 hours, 1 week)
- Number of animals or in vitro replicates:
- 3 with washing; 3 without washing
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, in one group
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Criteria of Draize - Irritation parameter:
- cornea opacity score
- Remarks:
- non-washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: Score: 10.0, 6.7, 6.7, 1.7, 0 resp. at t = 24, 48, 72, 96 h, 1 week
- Irritation parameter:
- iris score
- Remarks:
- non-washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.7
- Max. score:
- 5
- Reversibility:
- fully reversible within: 96 hours
- Remarks on result:
- other: Score: 5.0, 1.7, 1.7, 0, 0 resp. at t= 24, 48, 72, 96 h, 1 week
- Irritation parameter:
- conjunctivae score
- Remarks:
- non-washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 6
- Max. score:
- 6
- Reversibility:
- fully reversible within: 96 hours
- Remarks on result:
- other: Score: 12.7, 4.0, 0.7, 0, 0 resp. at t = 24, 48, 72, 96 h, 1 week
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Score: 0, 0, 0 resp. at t = 24, 48, 72 h
- Irritation parameter:
- iris score
- Remarks:
- washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Score: 0, 0, 0 resp. at t = 24, 48, 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Score: 2.7, 0, 0 resp. at t = 24, 48, 72 h
- Irritant / corrosive response data:
- In the non-washed group (3 animals), all of the cases showed conjunctival redness with a strength level of 1 and conjunctival edema with a strength level of 2 at 1 hour after Slz WX-R application, while 1 case showed iris hyperemia with a strength level of 1. No change in the strength of the conjunctival hyperemia was observed at 24 hours after application, but in all of the cases, the strength of the conjunctival redness increased to a level of 2. Further, 2 cases newly developed iris hyperemia with a strength level of 1, and all of the cases showed corneal opacity with a strength level of 1 and a breadth of 1 to 4 as well as eye discharge with a strength level of 2 to 3. These local reactions gradually lessened, with only 1 case showing corneal opacity with a strength level of 1 and a breadth of 1 at 96 hours after application. After 1 week, all of the local reactions had disappeared. In the washed group (3 animals), all of the cases showed conjunctival redness and conjunctival edema with a strength level of 1 at 1 hour after Slz WX-R application. By 24 hours after application, the conjunctival redness had disappeared in 1 case, and the conjunctival edema also disappeared in 2 cases. However, 1 case newly developed eye discharge with a strength level of 1. All of these local reactions disappeared by 48 hours after application.
Based on the above-noted results, the mean total scores for the local reactions in each tissue were calculated. The maximum value up to 72 hours after application was 27.7 at 24 hours after application in the non-washed group and 4.0 at 1 hour after application in the washed group. These results indicated that Slz WX-R showed moderate irritation of rabbit eyes in the non-washed group, with only extremely mild irritation in the washed group, demonstrating the effects of washing. - Other effects:
- none
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A study in 3 rabbits revealed that Slz WX-R 6 was moderately irritanting when the eyes were not washed and extremely mild irritating when the eyes were washed after 30 seconds of exposure. The study was not performed according to the general guidelines for acute eye irritation/corrosion under GLP conditions, but was well performed and documented and as such considered reliable with minor restrictions.
Reference
none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data are available from two dermal irritation/corrosion studies in albino rabbits; these studies do not meet the requirements of the current guidelines, however, one of the studies (Sunitomo, 1986) was well performed and documented.
Data are available from two eye irritation/corrosion studies in albino rabbits; these studies do not meet the requirements of the current guidelines, however one of the studies (Sunitomo, 1986) was well performed and documented.
The results of these studies indicate that the substance should not be classified as a skin irritant or as an eye irritant in accordance with the CLP Regulation.
Justification for selection of skin irritation / corrosion endpoint:
Most well documented study, conducted using methods that are similar to those described in OECD Guideline 404.
Justification for selection of eye irritation endpoint:
Most well documented study, conducted using methods that are similar to those described in OECD Guideline 405.
Justification for classification or non-classification
The available studies do not warrant a DSD/CLP classification for irritation.
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