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EC number: 200-076-7 | CAS number: 51-03-6
- 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:
- 1991
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Although nowadays in many member states of the EU the protocol byMagnusson and Kligmanis the preferred method, the Buehler test is a valid method according to OECD 406.
At the time of study conduction no such preference existed. The GPMT method was not preferred over the Buehler Test.
The Buehler test method has demonstrated its ability over the years to detect chemicals even with weak potential to sensitize human skin (Basketter DA, Gerberick GF. An interlaboratory evaluation of the Buehler test for the identification and classification of skin sensitizers. Contact Dermatitis. 35(3):146-51. 1996).
Thus, the Buehler test is a valid and reliable study to determine the skin sensitizing potency of PBO.
In the light of animal welfare a sensitization test according to the GPMT protocol was not conducted while a Buehler test was available
Test material
- Reference substance name:
- 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether
- EC Number:
- 200-076-7
- EC Name:
- 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether
- Cas Number:
- 51-03-6
- Molecular formula:
- C19H30O5
- IUPAC Name:
- 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Source Davidson Mill Farm, Gamesbourg, NJ 08831, USA
Age/weight at study initiation 356 - 415 g
Number of animals per group 10 animals (Modified Buehler test)
Control animals 10 animals
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- none
- Concentration / amount:
- 0.4mL
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- none
- Concentration / amount:
- 0.4mL
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene (Eastman Kodak Co., Rochester, NY), as a 0.1% w/v dilution in 50% ethanol: 0.9 % saline solution
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- positive control
- Dose level:
- 0.1% w/v dilution in 50% ethanol: 0.9% saline solution
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema, Edema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% w/v dilution in 50% ethanol: 0.9% saline solution
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema
- Remarks on result:
- positive indication of skin sensitisation
- Group:
- negative control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Results of pilot studies:
Prior to the main test, the test article was screened as supplied at concentrations of 75% v/v, 50% v/v and 25% v/v in corn oil (Mazola corn oil, Best Foods, CPC International Inc., Englewood cliffs, NJ 07632) to determine its minimal irritation threshold and its highest non-irritating concentration. After a 6-hour skin contact period, the test article at all levels produced no skin irritation.
1.1 Results of test |
|
1.1.1 24h after challenge |
All animals showed neither edema nor erythema 24 hours after termination of challenge |
1.1.2 48h after challenge |
All animals showed neither edema nor erythema 48 hours after termination of challenge |
1.1.3 Other findings |
The group of naive guinea pigs served as irritation controls also showed no effects. |
-sensitization reaction: the test substance did not show any reactions at any interval.
Therefore, it is not a dermal sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The naive positive control animals were negative at challenge. For the DNCB positive control sensitisation was demonstrated.
Although in the group treated with Piperonyl Butoxide there were scattered 1+ readings during the induction applications in the 10 test guinea pigs, the challenge application was completely negative. The naïve controls were all negative.
Piperonyl Butoxide has no sensitizing potential under the conditions of the Modified Buehler Test. Skin sensitization was not provoked following the challenge phase.
The test article administered dermally as supplied doesn’t appear to be a dermal sensitizer to albino guinea pigs, under the study conditions utilized.
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