Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Jun. 20, 1990 to Aug. 5, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No OECD guideline available with which to compare the study design. Details of the study methods, dose preparation, animal husbandry, observations and results are well described.
- GLP compliance:
- yes
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]
- Details on test material:
- - Stability under test conditions: not applicable
- Storage condition of test material: at room temperature, radiolabelled substance at -20 degrees Celcius
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- pig
- Strain:
- other: Troll Miniature
- Sex:
- male
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Vaseline
- Duration of exposure:
- 24 hours
- Doses:
- - Nominal doses: 2 or 20 mg/kg bw
- No. of animals per group:
- 2/treatment group; 1 in control group
- Control animals:
- yes
- Remarks:
- vehicle only
Results and discussion
Percutaneous absorption
- Dose:
- 2 or 20 mg/kg bw
- Parameter:
- percentage
- Absorption:
- ca. 0.5 %
- Remarks on result:
- other: 24 hour
- Remarks:
- reported to be 0.53%
- Conversion factor human vs. animal skin:
- Not reported
Any other information on results incl. tables
From the miniature pigs in animal group A (low dose administration) in the mean 0.17 % of the radioactivity administered were excreted during 168 h. From the animals of animal group B (high dose administration) 0.03 % of the total radioactivity administered were excreted during 168 h. The nominal amount weighed for radioactivity determination was 1 ml.
With faeces from Animal Al 0.01 % and from animal A2 less than 0.005 % of the radioactivity administered have been excreted. From Animals Bl and B2 the amount of test substance excreted was always below the limit of detection. Thus elimination of radioactivity with faeces was negligible. The nominal amount weighed of faeces samples for determination of radioactivity was 0.75 g. From animal group B (high dose) only the sample obtained 48 h pa from animal B2 was above the limit of detection. This sample contained 0.164 kBq and coresponded to 0.0005 % of the total administered radioactivity.
Applicant's summary and conclusion
- Conclusions:
- In the mean of all four animals the sum of the percentage of radioactivity, recovered in all biological samples, was below 0.5 % of the administered radioactivity. Because the % of test material in the residual carcass ofthe miniature pigs could not be determined, the percentage in carcass was approximated from a rat study. Therefrom in the mean 0.53 % of the total administered test item was totally absorbed by the animals via the dermal route.
- Executive summary:
To investigate the absorption, distribution and elimination of dermally applied test material two animal groups of troll miniature pigs have been used. Animal group A received a low dose of about 19 mg test item and animal group B received a high dose of about 195 mg. The test substance was administered dermally for 24 hours. Urine and feces were collected from 0-168 h in 24 h intervals. With animal group A an average of 0.17 % of the administered radioactivity was eliminated in urine and less than 0.01 % in feces. With animal group B only 0.03 % was eliminated in urine and radioactivity in feces was always below the limit of detection. With both animal groups the major part of elimination of radioactivity in urine occurred during the first 48 h after administration of the test substance. Residues of the test item in organs and tissues were found in liver, kidney, adrenals, thyroid and
subcutaneous fat of the application area. The highest residues were found in liver (2-4 ng equiv./g with animal group A and 5-22 ng equiv./g with animal group B), subcutaneous fat of the application area (21-23 ng equiv./g with animal group A and 11 ng equiv./g with animal B2) and adrenals (1-3 ng equiv./g with animal group A and 16 ng equiv./g with animal Bl). The recovery of radioactivity in terms of radioactivity balances was 91 % for animal group A and 91.8 % for animal group B. Most of the radioactivity was recovered with the bandage, 90.2 % with animal group A and 91.6 % with animal group B. The blood and plasma level profiles showed with all animals only few samples above the limit of detection. Therefore a kinetic analysis of the blood and plasma level profiles could not be performed. The values were always below 2 ng equiv./g with animal group A and below 5 ng equiv./g with animal group B. In the mean of all four animals the sum of the percentage of radioactivity, recovered in all biological samples, was below 0.5 % of the administered radioactivity. Because the % of test material in the residual carcass ofthe miniature pigs could not be determined, the percentage in carcass was approximated from a rat study. Therefrom in the mean 0.53 % of the total administered test item was totally absorbed by the animals via the dermal route.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.