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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
One reliable study is available for the Reaction mass of AminoPhosphonium salt and Bisphenol AF (XA 31) for the acute oral toxicity.
In an acute oral study in rats, no animals died and no signs of overt toxicity were observed at the limit dose-level of 2000 mg/kg bw.Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- On occasions the relative humidity was outside the target range of 30 to 70%. This was considered not to affect the purpose or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- yes
- Remarks:
- On occasions the relative humidity was outside the target range of 30 to 70%. This was considered not to affect the purpose or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 3706OB
- Expiration date of the batch: 31 December 2018
- Purity test date: > 99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:room temperature in the dark - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: eight to twelve weeks of age.
- Weight at study initiation:
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:acclimatization period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °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.
: - Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE:
The test item was freshly prepared, as required, as a solution in dimethyl sulphoxide. Dimethyl sulphoxide was used because the test item did not dissolve/suspend in distilled water.
The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 300 mg/kg was chosen as the starting dose.In the absence of toxicity at a dose level of 300 mg/kg, the dose level of 2000 mg/kg was tested.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose level to confirm the survival of the previously dosed animals. - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- Dose level 300 mg/Kg : 1 female
Dose level 2000 mg/Kg : 1 female
Dose level 2000 mg/Kg : 4 females
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing /Other examinations performed:
Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily.
Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality. (See Table 1 in "any other information on results incl. tables")
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period. (See Table 1 in "any other information on results incl. tables")
- Gross pathology:
- No abnormalities were noted at necropsy. (See Table 3 in "any other information on results incl. tables")
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.
According to the Globally Harmonized Classification System, the test does not meet the criteria for classification. - Executive summary:
The acute oral toxicity of the test item in the Wistar strain rat was assessed using the Fixed Dose Procedure according to the OECD Test Guideline 420.
The study was conducted in compliance with the principles of Good Laboratory Practice.
A sighting test at dose levels of 300 mg/kg and 2000 mg/kg was initially performed. Then a further group of four fasted females was given a single oral dose of test item, as a solution in dimethyl sulphoxide, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored over the 14-day observation period. All animals were subjected to gross necropsy.
In this study, no deaths occurred and no signs of systemic toxicity were noted during the observation period. All animals showed expected gains in body weight and finally no abnormalities were noted at necropsy.
Therefore, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. Thus, according to the Globally Harmonized Classification System, the test does not meet the criteria for classification.
Reference
Dose Level - 300 mg/kg
- Mortality: There was no mortality.
- Clinical Observations: No signs of systemic toxicity were noted during the observation period.
- Body Weight: The animal showed expected gains in body weight over the observation period.
- Necropsy: No abnormalities were noted at necropsy.
Dose Level - 2000 mg/kg
Table 1 : Individual Clinical Observations and Mortality Data - 2000 mg/kg
Dose level mg/k |
Animal Number and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
|
|
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
2000 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: Individual Body Weights and Body Weight Changes - 2000 mg/kg
Dose Level mg/kg |
Animal Numberand Sex |
Body Weight (g) at Day |
Body Weight gain (g) during week |
|||
|
|
0 |
7 |
14 |
1 |
2 |
2000 |
2-0 Female |
203 |
227 |
230 |
24 |
3 |
|
3-0 Female |
171 |
182 |
200 |
11 |
18 |
|
3-1 Female |
169 |
190 |
196 |
21 |
6 |
|
3-2 Female |
170 |
184 |
200 |
14 |
16 |
|
3-3 Female |
186 |
203 |
216 |
17 |
13 |
Table 3: Individual Necropsy Findings - 2000 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Time of Death |
Macroscopic observations |
2000 |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-1 Female |
Killed Day 14 |
No abnormalities detected |
|
3-2 Female |
Killed Day 14 |
No abnormalities detected |
|
3-3 Female |
Killed Day 14 |
No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is GLP-compliant and is scored 1 according to Klimisch reliability criteria.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The acute oral median lethal dose (LD50) was greater than 2000 mg/kg body weight. According to the Globally Harmonized Classification System, the test does not meet the criteria for classification.
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