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EC number: 943-265-6 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
Based on in vivo studies in rabbits (OECD 404 and 405, respectively), the Reaction mass of AminoPhosphonium salt and Bisphenol AF is considered as non-irritating to the skin and irritating to the eyes. As a precaution, the registered substance is also considered as a respiratory irritant.
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:
- May 2014 - August 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3706OB
- Expiration date of the lot/batch: 01 March 2019
- Purity test date: >99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: by Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: At the start of the study the animals weighed 2.65 or 2.80 kg
- Housing: suspended cages
- Diet / water: Free access to mains drinking water and food was allowed throughout the study
- Acclimation period: at least five
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g of the test item
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of distilled water
resulting to a 10% w/w aqueous preparation of the test item - Duration of treatment / exposure:
- Duration of treatment: 3 minutes, 1 hour and 4 hours after application.
- Observation period:
- 72 hours after exposure
- Number of animals:
- 2 animals
The number of animals used was the minimum required to achieve the objectives of the study. Testing was conducted on two animals and the response in these animals was such that exposure of a third animal would not affect classification of the test item, therefore no further testing was needed. - Details on study design:
- TEST SITE
- Area of exposure: 3
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
OBSERVATION TIME POINTS
Immediately following removal of the patches (3 minutes, 1 hour and 4 hours) and approximately 1, 24, 48 and 72 hours later
SCORING SYSTEM:
- Method of calculation: Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Skin irritation:
- 3-Minute Exposure Period: No evidence of skin irritation was noted during the study. (See table 1 in "Any other information on results incl. tables)
- 1-hour Exposure Period: No evidence of skin irritation was noted during the study.(See table 1 in "Any other information on results incl. tables)
- 4-hour Exposure Period: No evidence of skin irritation was noted during the study.(See table 2 in "Any other information on results incl. tables)
Body Weight: Both animals showed expected gain in body weight during the study. (See table 3 in "Any other information on results incl. tables) - Other effects:
- Measurement of pH:
10% w/w aqueous preparation of the test item immediately after preparation = 7.33
10% w/w aqueous preparation of the test item ten minutes after preparation = 7.33 - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures and the Globally Harmonized System of Classification and Labelling of Chemicals. - Executive summary:
The dermal irritancy potential of the test item following single, 3-Minute, 1 and 4-Hour, semi-occluded applications to the intact rabbit skin was assessed according to the OECD Guidelines for the Testing of Chemicals No.404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002). The study was conducted in compliance with the principles of Good Laboratory Practice.
At each test site a quantity of 0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water to achieve a paste, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch on three suitable sites selected on the back of the rabbit.
3-Minute and 1-Hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation. A single 4-Hour, semi occluded application of the test item to the intact skin of two rabbits produced no evidence of skin irritation.
The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item, Reaction mass of AminoPhosphonium salt and BisphenolAF, does not meet the criteria laid down in CLP; Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures and the Globally Harmonized System of Classification and Labelling of Chemicals.
Reference
Table 1 : Individual Skin Reactions Following 3-Minute and 1-Hour Exposures
Skin Reaction |
Observation Time (following patch removal) |
Individual Scores Rabbit Number and Sex 74487 Female |
||
|
|
3-Minute Exposure |
1-Hour Exposure |
|
Erythema/Eschar Formation |
Immediately |
0 |
0 |
|
|
1 Hour |
0 |
0 |
|
|
24 Hours |
0 |
0 |
|
|
48 Hours |
0 |
0 |
|
|
72 Hours |
0 |
0 |
|
Edema Formation |
Immediately |
0 |
0 |
|
|
1 Hour |
0 |
0 |
|
|
24 Hours |
0 |
0 |
|
|
48 Hours |
0 |
0 |
|
|
72 Hours |
0 |
0 |
Table 2 : Individual Skin Reactions Following 4-Hour Exposure
Skin Reaction
|
Observation Time (following patch removal)
|
Individual Scores |
Total |
|
|
|
Rabbit Number and Sex |
|
|
|
|
74487 Female |
74520 Female |
|
Erythema/Eschar Formation |
Immediately |
0 |
0 |
(0) |
|
1 Hour |
0 |
0 |
(0) |
|
24 Hours |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
(0) |
|
72 Hours |
0 |
0 |
0 |
Edema Formation |
Immediately |
0 |
0 |
(0) |
|
1 Hour |
0 |
0 |
(0) |
|
24 Hours |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
(0) |
|
72 Hours |
0 |
0 |
0 |
Sum of 24 and 72-Hour Readings (S) = 0 |
||||
Primary Irritation Index (S/4) : 0/4 = 0.0 |
||||
Classification: NON-IRRITANT |
( ) = Total values not used for calculation of primary irritation index
Table 3: Individual Body Weights and Body Weight Change
Rabbit Number and Sex |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
|
Day 0 |
Day 3 |
|
74487 Male |
2.80 |
2.95 |
0.15 |
74520 Male |
2.65 |
2.74 |
0.09 |
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:
- May 2014 - September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3706OB
- Expiration date of the lot/batch: 01 March 2019
- Purity test date: >99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.42 to 2.79 kg
- Housing: suspended cages
- Diet / Water: Free access to mains drinking water and food was allowed throughout the study
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness. - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of test item
VEHICLE
no vehicule - Duration of treatment / exposure:
- A single application of the test item
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment; Additional observations were made on Days 7 and 14 to assess the reversibility of the ocular effects.
- Duration of post- treatment incubation (in vitro):
- 14 days
- Number of animals or in vitro replicates:
- Three animals : 2 females and 1 male
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes 1 hour after treatment, in two treated eyes at the 24-Hour observation and persisted in one treated eye at the 48 and 72-Hour observations.
Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment. Moderate conjunctival irritation was noted in two treated eyes and minimal conjunctival irritation was noted in one treated eye at the 24, 48 and 72-Hour observations. Moderate conjunctival irritation persisted in one treated eye at the 7-Day observation.
Two treated eyes appeared normal at the 7-Day observation and one treated eye appeared normal at the 14-Day observation. - Other effects:
- Body Weight : All animals showed expected gain in body weight during the study.
Measurement of pH:
10% w/w aqueous preparation of the test item immediately after preparation = 7.33
10% w/w aqueous preparation of the test item ten minutes after preparation = 7.33 - Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the experimental conditions of this study and according to the criteria laid down in GHS, the test item is considered as as Irritating to eyes (Category 2A), due to the absence of complete reversibility 7 days following instillation.
- Executive summary:
The potential of the test item to induce eye irritation was assessed in New Zealand White rabbit according to the OECD Guidelines for the Testing of Chemicals No.405 "Acute Eye Irritation/Corrosion".The study was conducted in compliance with the principles of Good Laboratory Practice.
A single application of the test item to the non-irrigated eye of three rabbits produced iridial inflammation between 1 and 72 hours following dosing and moderate conjunctival irritation between 1 hour and 7 days following dosing. Two treated eyes appeared normal at the 7-Day observation and one treated eye appeared normal at the 14-Day observation.
The test item was classified as Irritating to eyes (Category 2A) according to the Globally Harmonized Classification System.
The Signal Word "Warning" and the Hazard Statement "H319: Causes serious eye irritation" are therefore required.
Reference
Table 1: Individual Scores for Ocular Irritation
Rabbit Number and Sex |
74530 Female |
74607 Female |
74667 Male |
||||||||||||||||||||||
IPR = 0 |
IPR = 0
|
IPR = 0 |
|||||||||||||||||||||||
Time After Treatment |
1 Hr |
24 Hr |
48 Hr |
72 Hr |
7 Dy |
1 Hr |
24 Hr |
48 Hr |
72 Hr |
7 Dy |
1 Hr |
24 Hr |
48 Hr |
72 Hr |
7 Dy |
14 Dy |
|||||||||
CORNEA |
|||||||||||||||||||||||||
Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||||
Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||||
IRIS |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
|||||||||
CONJUNCTIVAE |
|||||||||||||||||||||||||
1 Redness |
2 |
2 |
1 |
1 |
0 |
2 |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
2 |
0 |
|||||||||
1 Chemosis |
2 |
1 |
0 |
0 |
0 |
2 |
2 |
2 |
1 |
0 |
2 |
2 |
2 |
2 |
1 |
0 |
|||||||||
1 Discharge |
1 |
0 |
0 |
0 |
0 |
2 |
3 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
1 |
0 |
IPR= Initial Pain Reaction
Hr = Hours
Dy = Day
Table 2: Individual and Mean Scores for Cornea, Iris and Conjunctivae
Rabbit number and Sex |
Time After Treatment |
Corneal Opacity |
Iridial Inflammation |
Conjunctival Redness |
Conjunctival Chemosis |
74530 Female |
24 Hours |
0 |
0 |
2 |
1 |
|
48 Hours |
0 |
0 |
1 |
0 |
|
72 Hours |
0 |
0 |
1 |
0 |
Total
|
0 |
0 |
4 |
1 |
|
Mean
|
0.0 |
0.0 |
1.3 |
0.3 |
|
74607 Female |
24 Hours |
0 |
1 |
2 |
2 |
|
48 Hours |
0 |
0 |
2 |
2 |
|
72 Hours |
0 |
0 |
2 |
1 |
Total
|
0 |
1 |
6 |
5 |
|
Mean
|
0.0 |
0.3 |
2.0+ |
1.7 |
|
74667 Male |
24 Hours |
0 |
1 |
2 |
2 |
|
48 Hours |
0 |
1 |
2 |
2 |
|
72 Hours |
0 |
1 |
2 |
2 |
Total
|
0 |
3 |
6 |
6 |
|
Mean
|
0.0 |
1.0+ |
2.0+ |
2.0+ |
+ = Positive criterion according to CLP/GHS criteria.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the absence of specific data on respiratory irritation, and based on eye irritation potential, the test item Reaction mass of AminoPhosphonium salt and Bisphenol AF is considered as a respiratory irritant in a precautionary approach.
Justification for classification or non-classification
Based on GLP- and OECD TG-compliant studies, the Reaction mass of AminoPhosphonium salt and Bisphenol AF is classified as Eye Irrit. 2A, H319, according to the GHS criteria. A STOT SE 3, H335 classification is also applied.
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.