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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
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- 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
Endpoint summary
Administrative data
Description of key information
Reliable skin irritation study with Tetrabutylphosphonium bromide performed according to GLP principles, methods used equivalent to OECD guideline 404 (Klimisch 2).
Reliable eye irritation study with Tetrabutylphosphonium bromide according to GLP principles, methods used equivalent to OECD guideline 405, but with deviations.
Based on the results of these studies, the substance does not need to be classified for skin irritation/corrosion and needs to be classified as corrosive for eye irritation/corrosion.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- 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
- 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 - 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. - 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.
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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, but with deviations (0.081mg instilled instead of 0.1mg). As this amount resulted in severe effects, the test is regarded to be sufficient to fill this endpoint.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Lower amount test substance instilled, instillation into both eyes (one washed, one unwashed)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA, USA
- Age at study initiation: 3-4 months
- Weight at study initiation: 3.4 kg
- Housing: individually in suspended cage
- 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.081mg
- Duration of treatment / exposure:
- Single instillation
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was instilled in both eyes, one eye remained unwashed, one eye was flushed by lukewarm water for one minute.
- Time after start of exposure: 20 to 30 seconds
SCORING SYSTEM: Following numerical Draize technique (Draize, J.H. et al., J. Pharm. Exp. Ther. 82: 377-390, 1944), additional signs were described.
TOOL USED TO ASSESS SCORE: Mini-Maglite flashlight - Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- Corneal opacity, iritis and conjunctival irritation persisted until termination of the experiment (day 7). Pannus was noted on day 7. Discharge was noted at every observation time point.
- Other effects:
- Vocalization was noted post-dose.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- An eye irritation study was performed by instillation of 0.081mg tetrabutylphosphonium bromide in each eye of a rabbit. One eye remained unwahsed, one eye was flushed with lukewarm water. This resulted in severe effects during 7 days, after which the animal was sacrificed. Based on these results, the test substance is classified corrosive to the eye (cat. 1).
- Executive summary:
An eye irritation study was performed by instillation of 0.081mg tetrabutylphosphonium bromide in each eye of a rabbit. The test was done following GLP principles. One eye remained unwashed, one eye was flushed with lukewarm water. This resulted in severe irreversible effects during 7 days in the unwashed eye, after which the animal was sacrificed. Based on these results, the test substance is classified corrosive to the eye (cat. 1).
Reference
In the washed eye, corneal opacity and iritis were noted that had cleared on day 7. Conjunctival irritation was still noticeable at day 7. Animal exhibited lethargy, prostration and laboured breathing at time of ocular dosing and instances of lethargy and few faeces post-dosing.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
In a reliable in vivo skin irritancy study (Klimisch 2), 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 exposure 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.
Eye irritation/corrosion:
A reliable eye irritation study (Klimisch 2) was performed by instillation of 0.081 mg tetrabutylphosphonium bromide in each eye of a rabbit. The test was done following GLP principles. One eye remained unwashed, one eye was flushed with lukewarm water. This resulted in severe irreversible effects during 7 days in the unwashed eye, after which the animal was sacrificed. Based on these results, the test substance is classified corrosive to the eye (cat. 1).
Justification for classification or non-classification
According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments), Tetrabutylphosphonium Bromide; CYPHOS® 442 Phosphonium Salt should be classified as: irreversible effects to the eye (Category 1).
According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Tetrabutylphosphonium Bromide; CYPHOS® 442 Phosphonium Salt should be classified as Category 1 and should be labeled as H318: Causes serious eye damage.
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