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EC number: 221-487-8 | CAS number: 3115-68-2
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 June 2006 - 03 July 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study conducted according to GLP principles, methods used equivalent to OECD guideline 404.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- also application to abraded skin in the same rabbit (one animal died 4 hrs post-dose)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrabutylphosphonium bromide
- EC Number:
- 221-487-8
- EC Name:
- Tetrabutylphosphonium bromide
- Cas Number:
- 3115-68-2
- Molecular formula:
- C16H36P.Br
- IUPAC Name:
- tetrabutylphosphanium bromide
- Test material form:
- other: waxy solid
- Details on test material:
- - Name of test material (as cited in study report): CYPHOS 442 (CT-851-06)
- Substance type: organic
- Physical state: White waxy solid (odorless)
- Storage condition of test material: Room temperature and humidity
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA, USA
- Age at study initiation: 3-4 months
- Weight at study initiation: 2.5-3.4 kg
- Housing: individually in suspended cages
- Diet: PMI Rabbit Chow, provided daily
- Water: ad libitum
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Experiments conducted in temperature-controlled animal room
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 June 2006 - 03 July 2006
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm * 2.5 cm
- Type of wrap if used: surgical gauze patches were secured with non-adhesive tape, the torso was wrapped with plastic fitted with a window to allow dermal observations during the 4 hour exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):no, test substance was removed by gentle wiping
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to Draize, J.H., J. Pharm. Exp. Ther. 82: 377-390, 1944), additional signs were described.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Erythema was absent to very slight at 3 minutes after dosing and very slight to well defined at 1 and 4 hours. Edema was absent at 3 minutes after dosing, absent to very slight at 1 hour after dosing and absent to well defined at 2 hours.
At 24 hours after the 4 hour exposure, erythema was very slight to well defined. At 48 hours, erythema was well-defined and by 72 hours erythema was very slight to well defined. Edema was absent to very slight at 24, 48 and 72 hours. By day 7, erythema was absent in one animal, but very slight in another. Edema was absent on day 7. By day 14, both erythema and edema were absent. - Other effects:
- One female died during 4 hour exposure period.
Any other information on results incl. tables
The results of the abraded skin are as follows:
|
|
Erythema |
Eschar formation |
24 hours |
Mean of two animals |
2 |
1 |
48 hours |
Mean of two animals |
2 |
0.5 |
72 hours |
Mean of two animals |
1.5 |
0.5 |
All skin effects were reversible within maximally 2 weeks.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An in vivo skin irritancy study was conducted according to GLP principles and equivalent to OECD guidelines.Based on the outcome of this study, the test substance is not classified as corrosive or irritant to the skin.
- Executive summary:
In an in vivo skin irritancy study, three rabbits were dosed with 0.5 g test substance to intact (right flank) and abraded skin (left flank). One female died within 4 hour expsoure period. Erythema was absent to very slight at 3 minutes after dosing and very slight to well defined at 1 and 4 hours. Edema was absent at 3 minutes after dosing, absent to very slight at 1 hour after dosing and absent to well defined at 2 hours. At 24 hours after the 4 hour exposure, erythema was very slight to well defined. At 48 hours, erythema was well-defined and by 72 hours erythema was very slight to well defined. Edema was absent to very slight at 24, 48 and 72 hours. By day 7, erythema was absent in one animal, but very slight in another. Edema was absent on day 7. By day 14, both erythema and edema were absent. One female died during 4 hour exposure period, however this does not influence the validity of the study as all effects in two remaining animals were reversible and scores were <2 in 2 animals. Based on the outcome of this study, it can be concluded that the test substance is not classified as corrosive or irritant to the skin.
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