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EC number: 201-618-5 | CAS number: 85-60-9
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study report not detailed or referencing any documented guideline followed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Shelanski and Shelanski (Proceedings of the Toilet Goods Association No. 19, May 1953)
- GLP compliance:
- no
Test material
- Reference substance name:
- 6,6'-di-tert-butyl-4,4'-butylidenedi-m-cresol
- EC Number:
- 201-618-5
- EC Name:
- 6,6'-di-tert-butyl-4,4'-butylidenedi-m-cresol
- Cas Number:
- 85-60-9
- Molecular formula:
- C26H38O2
- IUPAC Name:
- 2-tert-butyl-4-[1-(5-tert-butyl-4-hydroxy-2-methylphenyl)butyl]-5-methylphenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sample No. 131 - Santowhite Powder, Lot No. NE 10-010
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- 50 human subjects utilised.
No further information specified within the report. - Clinical history:
- None of the subjects of this test had been utilised previously for patch testing.
No further information specified within the report. - Controls:
- Not specified
- Route of administration:
- dermal
- Details on study design:
- The test material was applied to linteen discs approximately 0.25 square inches in area. These were then applied to the upper arms of the subjects and held in place with Blenderm tape. After 24 hours the patches were removed and re-actions graded and recorded. A rest period of 24 hours then elapsed after which the patches were re-applied as before. This sequence was repeated until fifteen successive patches had been applied. A two week rest period was then allowed after which a challenge application was applied as before. All applications were made to the same site.
Results and discussion
- Results of examinations:
- There were no reactions produced by any of the primary application or by the challenge.
Any other information on results incl. tables
Repeated Insult Patch Test with Sample No. 131 – Santowhite Powder, Lot No. NE 10-010 Results
Number of subjects negative throughout 50
Number of subjects showing reactions 0
Number of Application |
Number of Reactions in the Grades Indicated* |
||||
0 |
1+ |
2+ |
3+ |
4+ |
|
1 |
50 |
0 |
0 |
0 |
0 |
2 |
50 |
0 |
0 |
0 |
0 |
3 |
50 |
0 |
0 |
0 |
0 |
4 |
50 |
0 |
0 |
0 |
0 |
5 |
50 |
0 |
0 |
0 |
0 |
6 |
50 |
0 |
0 |
0 |
0 |
7 |
50 |
0 |
0 |
0 |
0 |
8 |
50 |
0 |
0 |
0 |
0 |
9 |
50 |
0 |
0 |
0 |
0 |
10 |
50 |
0 |
0 |
0 |
0 |
11 |
50 |
0 |
0 |
0 |
0 |
12 |
50 |
0 |
0 |
0 |
0 |
13 |
50 |
0 |
0 |
0 |
0 |
14 |
50 |
0 |
0 |
0 |
0 |
15 |
50 |
0 |
0 |
0 |
0 |
Challenge |
50 |
0 |
0 |
0 |
0 |
*Scoring Criteria
0 = No reaction.
1+ = Slight erythema.
2+ = Marked erythema.
3+ = Marked erythema, edema, with or without a few vesicles.
4+ = Marked erythema, edema, with vesicles and oozing.
Applicant's summary and conclusion
- Conclusions:
- Sample No. 131 - Santowhite Powder, as tested, is neither a primary irritant nor a fatiguing agent.
- Executive summary:
Sample No. 131 - Santowhite Powder, as tested, is niether a primary irritant nor a fatiguing agent. There was no evidence that the material has any sensitizing action.
In so far as sensitization is concerned, the extrapolation of these results to a general population is limited statistaically by the number of test subjects. In this case, since fifity subjects were used, we may predict with 95% certainty that a least 92% of a general population will not be sensitized by this material.
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