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EC number: 253-039-2 | CAS number: 36443-68-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Sept. 20, 1982 to Dec. 30, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Two intradermal and one epicutanous induction treatments; no sodium lauryl sulphate applied, no summary of the results of the reliability check provided.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Since valid in vivo data are available, no LLNA is necessary.
Test material
- Reference substance name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- EC Number:
- 253-039-2
- EC Name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- Cas Number:
- 36443-68-2
- Molecular formula:
- C34H50O8
- IUPAC Name:
- ethane-1,2-diylbis(oxyethane-2,1-diyl) bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propanoate]
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pribright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas Dermany
- Age at study initiation: 10 weeks old
- Weight at study initiation: 291 to 485 g
- Housing: individually in macrolon cages
- Diet: ad libitum standard guinea pig pellets NAFAG no. 830 supplemented with fresh carrots.
- Water: ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 50 +/- 10%
- Photoperiod (hrs dark / hrs light): 10 hrs dark/ 14 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 1%
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline PhH VI
- Concentration / amount:
- 30%
- Day(s)/duration:
- 48 h
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline PhH VI
- Concentration / amount:
- 30%
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- 10 male and 10 female per group
- Details on study design:
- RANGE FINDING TESTS:
The concentrations of the test compound for induction and challenge periods were determined on separate animals.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two (intradermal and epicutaneous)
- Test groups: three pairs of intradermal injections (0.1 ml per injection) into the neck of the guinea-pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. One week later the test article was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals epicutaneously for 48 hours.
- Control group: treated with the vehicles alone
- Site: neck
- Concentrations: 1% for intradermal injection and 30% for epidermal application
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Exposure period: 24 hours
- Test groups: Two weeks after the epidermal induction application the animals were tested on the flank with in vaseline
- Control group: treated with the vehicles alone
- Site: flank
- Concentrations: 30%
- Evaluation (hr after challenge): 24 and 48 hours after removing the dressings the challenge reactions were graded according the Draize scoring scale - Challenge controls:
- Vehicle only
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- The sensitivity of the strain is controlled every six months with p-phenylenediamine. No values given in the report.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 % (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 % (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% (epicutanous)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% (epicutanous)
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
One animal died during the performance of the test. The death of the animal can not related to the compound application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No animal was sensitized by the test item under the experimental conditions employed and the test item can, therefore, be classified to the lowest sensitization grade according to Magnusson and Kligman (Appendix 2)
- Executive summary:
In order to investigate the sensitization potential of the test item a maximization test according to Magnusson and Kligman was peformed using 10 male and 10 female guinea-pigs. Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea-pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. One week later was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours). Two weeks after the epidermal induction application the animals were tested on the flank with in vaseline (24 h occlusive application). Twenty-four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. The application sites were chemically depilated 3 hours before examination (Veet, 5 minutes) per group. A control group was treated with the vehicles alone (negative control). One animal died during the performance of the test. The death of the animal can not related to the compound application. No animal reacted after the challenge application and the test itel can therefore be classified to the lowest sensitization grade of Magnusson and Kligman.
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