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Diss Factsheets
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EC number: 218-216-0 | CAS number: 2082-79-3
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 963
- Report date:
- 1963
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- GLP compliance:
- no
Test material
- Reference substance name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 218-216-0
- EC Name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 2082-79-3
- Molecular formula:
- C35H62O3
- IUPAC Name:
- octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Details on test material:
- - Physical state: white powder
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 58
- Sex: 15 males and 43 females
- Age: 16-73 years - Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: test patch was a 3/4 x 7/8-inch swatch of Webril moistened with 0.5 ml of the test solution and held to the skin with a Duke Elastoplast Coverlet.
- Vehicle / solvent: dimethyl phthalate
- Concentrations: 0.5 gm per 100 ml
- Volume applied: 0.5 ml
- Testing/scoring schedule: 9 applications were performed. For the challenge duplicate patches were applied, one to the original test site and the second to an area not previously exposed to the test solution.
- Removal of test substance: 24 h after application
EXAMINATIONS
- Grading/Scoring system: Reactions were scored on the following scale:
0 No evidence of irritation
1 Slight erythema
2 Marked erythema
3 Erythema and papules
4 Erythema and edema
5 Erythema, edema and papules
6 Vesicular eruption
7 Strong reaction extending beyond test area
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 57
- Number of subjects with irritating reactions: 0/57, 5/52, 7/50, 4/53, 9/48, 2/55, 7/50, 5/49, 5/47 persons exhibited irritation responses (with score 1/ total tested) after 1, 2, 3 ,4, 5, 6, 7, 8 and 9 applications, respectively. 1/50 and 1/49 exhibited score 3 after 7 and 8 applications, respectively.
Any other information on results incl. tables
Only 1 subject, a 16-year-old girl, exhibited a grade 6 reaction centered on the test site with an area of edema and induration extending several inches in each direction. During the following week this became still more severe, involving most of the arm, with vesicles over some areas. She responded to topical and internal medication, and when last seen exhibited only some residual erythema on and around the test site. She had reported an earlier dermatitis following use of Cuticura, otherwise her dermatological history was negative.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test 0.5% test substance in dimethyl phthalate causes little irritation. One of 58 subjects became sensitive to the test material during the test.
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