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EC number: 216-036-7 | CAS number: 1478-61-1
- 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
Acute Oral Toxicity: LD50 (rats, combined) ≥ 2000 mg/kg bw; OECD 420; Anon. (2001a)
Acute Inhalation Toxicity: Waiver
Acute Dermal Toxicity: LD50 (rats, combined) ≥ 2000 mg/kg bw; OECD 402; Anon. (2001b)
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:
- 13 February - 02 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with International guidelines and in accordance with GLP. All guideline validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark
- Stability under test conditions: Not reported
- Solubility and stability of the test substance in the solvent/vehicle: Not reported
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not reported
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item formulated in propylene glycol within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: Not reported
- Final preparation of a solid: N/A
FORM AS APPLIED IN THE TEST (if different from that of starting material): Liquid
OTHER SPECIFICS: Homogeneity of formulation confirmed by visual inspection. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: ca. 9 weeks
- Weight at study initiation: Did not exceed ± 20 % of the sex mean
- Fasting period before study: Yes - 20 h prior to dosing (max.) and for 3-4 h after dosing.
- Housing: 3 animals housed per Macrolon cage (Type IV, height 15 cm) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenburg, Germany).
- Diet (e.g. ad libitum): Standard pelleted laboratory animal diet (from Altromin (Code VRF 1)) provided ad libitum.
- Water (e.g. ad libitum): Tap water provided ad-libitum.
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): ca. 15.
- Photoperiod (hrs dark / hrs light): 12:12 light:dark
IN-LIFE DATES: From: To: Not reported - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not reported
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Guideline recommended
- Lot/batch no. (if required): Not reported
- Purity: Not reported
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION (if unusual): Test item formulated in propylne glycol within 4 hours prior to dosing. Homogeneity of formulation confirmed by visual inspection.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not reported - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality were made twice daily. Bdy weights were recorded on Day 1 (pre-dose) and Day 8 and 15. Clinical signs were recorded once daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights and necropsy. - Statistics:
- Not performed
- Preliminary study:
- N/A
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- lethargy (hypoactivity)
- Body weight:
- lower than 10% body weight loss
- Remarks:
- Slight body weight loss in individuals animals was noted between day 1 and 8 (1 male -12% and 1 female -8%).
- Gross pathology:
- No abnormalities were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of the test item in Wistar rats exceeded 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (OECD 423) groups of fasted, 9 week old, Wistar rats (3 male, 3 female) were given a single oral dose of test item in propylene glycol at a single dose of 2000 mg/kg bw and observed for 14 days.
No mortality was observed in the limit test.
Clinical signs of toxicity were observed in 2 /3 females, namely hunched posture between Days 1 - 3 and 7 - 9. Clinical signs of toxicity were also observed in all of the males rats including lethargy, hunched posture, chromodacryorrhoea, rales and/or piloerection between Days 1 - 7. Salivation was also observed in all male rats however this is commonly seen after treatment by oral gavage and was therefore not considered to be of toxicologial relevance. No macroscopic abnormalities were observed in the post mortem examination.
Reference
Table 2: Number of animals dead (and with evident toxicity) (and time range within which mortality occured)
Nominal dose (mg/kg bw) |
Mortality (No. dead / total) |
Time range of deaths (hours) |
Clinical signs (No. / total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
0 /3 |
0 / 3 |
0 / 6 |
N/A |
3 / 3 |
2 / 3 |
5 / 6 |
N/A not applicable
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- >= 2 000 mg/kg bw
- Quality of whole database:
- The endpoint is concluded based on a single key study with a Klimisch rating of 1. No effects were observed up to the limit dose of 2000 mg/kg bw.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The substance meets the Annex VIII, Section 8.5.2, Column 2 criteria as the vapour pressure is 5E-06 Pa. The use pattern for the substance will not present situations where exposure to aerosols, particles or droplets of an inhalable size is relevant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The acute inhalation toxicity study was waived in accordance with Annex VIII, Section 8.5.2, Column 2.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 February - 14 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with International guidelines and in accordance with GLP. All guideline validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark
- Stability under test conditions: Not reported
- Solubility and stability of the test substance in the solvent/vehicle: Not reported
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item formulated using proylene glycol within 4 h of dosing.
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: Not reported
- Final preparation of a solid: N/A
FORM AS APPLIED IN THE TEST (if different from that of starting material): Liquid
OTHER SPECIFICS: Homogeneity of the formulation was confirmed by visual inspection. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: ca. 8-9 weeks old
- Weight at study initiation: ± 20 % of the sex mean
- Fasting period before study: No
- Housing: Individually housed in polycarbonate cages (Type III, height 15 cm) containing purifed sawdust as bedding (SAWI, Jelu Werk, Rosenburgh, Germany).
- Diet (e.g. ad libitum): Standard pelleted laboratory animal feed (from Altorim (code VRF 1)) provided ad libitum.
- Water (e.g. ad libitum): Tap water provided ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 ºC
- Humidity (%): 30 - 70 % relative humidity (RH)
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12:12 light:dark
IN-LIFE DATES: From: To: Not reported - Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back
- % coverage: 10
- Type of wrap if used: Surgical gauze (Surgy 1D) covered with aluminium foil and Coban flexible bandage. Dressings on females were further fixed with Micropore tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes- water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bodyweight
- Concentration (if solution): Not reported
- Constant volume or concentration used: Not reported
- For solids, paste formed: N/A
VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical signs were made twice daily. Body weights were recorded on Day 1 (pre-exposure), Day 8 and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weight. - Statistics:
- Not performed
- Preliminary study:
- Not conducted
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured
- Clinical signs:
- lethargy (hypoactivity)
- Body weight:
- lower than 10% body weight loss
- Remarks:
- Slightly body weigh loss was noted in 2 females between day 1 and 8.
- Gross pathology:
- No abnormalities were noted.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of the test item in Wistar rats exceeded 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study (OECD 402) groups of young adult Wistar rats (male and female) were dermally exposed to test item in ethylene glycol for 24 hours to 10 % of the total skin area at a single dose 2000 mg/kg bw. Animals then were observed for 14 days.
No mortality was observed in the limit test.
Clinical signs of toxicity were observed in all individuals including lethargy, tremor, hunched posture, chromodacryorrhoea, ptosis, quick breathing and/or piloerection were noted among the animals between Day 1 - 9. In one female hunched posture was noted until Day 13. In a second female chromodacryorrhoea was noted between Day 9 - 12. In another female chromodacryorrhoea was noted from Day 9 on wards. General erythema, scales, scabs and/or swelling were seen in the treated skin-area of the animals during the observation period. Reduced body weight gain was observed in the males between Day 1 - 8 and among females through the whole study period. Slight body weight loss was observed in some females between Day 1 – 8. No macroscopic abnormalities were observed in the post mortem examination.
Reference
Table 2: Number of animals dead (and with evident toxicity) (and time range within which mortality occured)
Nominal dose (mg/kg bw) |
Mortality (No. dead / total) |
Time range of deaths (hours) |
Clinical signs (No. / total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
0 /5 |
0 / 5 |
0 / 10 |
N/A |
5 / 5 |
5 / 5 |
10 / 10 |
N/A not applicable
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- >= 2 000 mg/kg bw
- Quality of whole database:
- The endpoint is concluded based on a single key study with a Klimisch rating of 1. No effects were observed up to the limit dose of 2000 mg/kg bw.
Additional information
Acute toxicity: oral
OECD 423 (2001a) - In an acute oral toxicity study, a group of fasted, 9 week old Wistar rats (3 male, 3 female) were given a single oral dose of Bisphenol AF in propylene glycol at a single dose of 2000 mg/kg bw and observed for 14 days.
In the absence of mortality during the observation period, the oral LD50 was estimated to be greater than 2000 mg/kg bw. Clinical signs of toxicity observed were lethargy, hunched posture, chromodacryorrhoea, rales and/or piloerection between Days 1 – 7 in all male animals. In female rats, hunched posture was observed between day 1-3 and 7-9. Salivation was also observed in all male rats however this is commonly seen after treatment by oral gavage and was therefore not considered to be of toxicologial relevance. No macroscopic abnormalities were observed in the post mortem examination.
Acute toxicity: dermal
OECD 402 (2001b) - In an acute dermal toxicity study, groups of young adult Wistar rats (5 males and 5 females) were dermally exposed to Bisphenol AF in ethylene glycol for 24 hours to 10 % of the total skin area at a single dose 2000 mg/kg bw. Animals then were observed for 14 days.
Clinical signs of toxicity were observed in all individuals included; lethargy, tremor, hunched posture, chromodacryorrhoea, ptosis, quick breathing and/or piloerection noted among the animals between Day 1 – 9. Hunched posture was noted in one female until day 13 and chromodacryorrhoea in 2 females between Day 9 – 12. General erythema, scales, scabs and/or swelling were seen in the treated skin-area as well as reduced weight gain in all treated animals. No macroscopic abnormalities were observed in the post mortem examination.
Justification for classification or non-classification
Bisphenol AF does not meet the criteria for classification under GHS or Regulation (EC) No 1272/2008 (CLP).
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