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EC number: 939-702-5 | 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
A reliable oral acute toxicity study is available on 2 -moles Ethoxylated bisphenol A dimethacrylate, which is not harmful by oral route with an oral LD50 higher than 35 000 mg/kg bw.
A dermal acute toxicity study was performed; no mortality was observed at 2000 mg/kg in rats, therefore the dermal LD50 is higher than 2000 mg/kg.
There is no available study by inhalation.
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:
- 1975-03-18, 1975-03-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Test substance was administered undiluted in the highest tolerable amount of 30 ml/kg bw to groups of 10 males and 10 females.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute's colony
- Age at study initiation: no data
- Weight at study initiation: males 104-225g, females 79-194g
- Fasting period before study: forr 18 hours prior dosing
- Housing: in groups of five in screen-bottomed stainless steel cages
- Diet (e.g. ad libitum): stock diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25°C
- Humidity (%): no data
- Air changes (per hr): no details, "well-ventilated" room
- Photoperiod (hrs dark / hrs light): no data - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- no
- Doses:
- 30 ml/kg (corresponding to 35 g/kg)
- No. of animals per sex per dose:
- 10 males and 10 females per dose
- Control animals:
- no
- Details on study design:
- Animals were observed during 14 days for signs of intoxication.
Autopsies were carried out on the surviving animals at the end of the 14-days period. - Statistics:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 35 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: No mortality observed
- Mortality:
- No death occurred during the observation period.
- Clinical signs:
- other: None of the treated animals showed any reaction upon treatment.
- Gross pathology:
- At the end of the 14-days period the survivors revealed no gross pathological changes.
- Other findings:
- Obviously both materials are of a very low acute oral toxicity. No difference in acute toxicity was observed between two samples.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to these results, oral LD50 of test item is higher than 35 000 mg/kg bw in rats.
- Executive summary:
Test substance was administered undiluted in the highest tolerable amount of 30 ml/kg bw (corresponding to 35 000 mg/kg bw) to groups of 10 males and 10 females. Animals were observed during 14 days for signs of intoxication. Autopsies were carried out on the surviving animals at the end of the 14-days period.
No death occurred during the observation period. None of the treated animals showed any reaction upon treatment. At the end of the 14-days period the survivors revealed no gross pathological changes. According to these results, oral LD50 of test item is higher than 35 000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 35 000 mg/kg bw
- Quality of whole database:
- This oral acute study is considered to be reliable with a klimisch score of 2.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- 23 October 2012 - 06 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No 8147, April 2011; including the most recent partial revisions.
- Version / remarks:
- 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 12 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Individual housing in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
IN-LIFE DATES: From: 23 October 2012 - 06 November2012 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
The test substance was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminum foil and Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.
*. Manufacturers: Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul, Minnesota, U.S.A. (Coban & Micropore).
Frequency: Single dosage, on Day 1.
Washing: Following application, dressings were removed and the skin cleaned of residual test substance using tap water. - Duration of exposure:
- 24 hours.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Dose volume: 1.79 mL/kg, calculated as dose level (g/kg) / specific gravity.
Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weights: Twice daily.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none. - Statistics:
- None.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical signs were noted.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal study in rats, the dermal LD50 value of 2 moles ethoxylated bisphenol A dimethacrylate was established to exceed 2000 mg/kg body weight. Based on these results, 2 moles ethoxylated bisphenol A dimethacrylate does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and
mixtures (CLP), including all amendments. - Executive summary:
2-moles ethoxylated bisphenol A dimethacrylate was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred and no clinical signs were noted. The mean body weight gain during the observation period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
The dermal LD50 value of 2 moles ethoxylated bisphenol A dimethacrylate in Wistar rats was established to exceed 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- This dermal acute study is considered to be reliable with a klimisch score of 1.
Additional information
Acute toxicity : via oral route (TNO 1975)
2-moles ethoxylated bisphenol A dimethacrylate was administered undiluted in the highest tolerable amount of 30 ml/kg bw (corresponding to 35 000 mg/kg bw) to groups of 10 males and 10 females. Animals were observed during 14 days for signs of intoxication. Autopsies were carried out on the surviving animals at the end of the 14-days period.
No death occurred during the observation period. None of the treated animals showed any reaction upon treatment. At the end of the 14-days period the survivors revealed no gross pathological changes. According to these results, oral LD50 of test item is higher than 35 000 mg/kg bw in rats.
Acute toxicity : via dermal route (WIL 2013)
2-moles ethoxylated bisphenol A dimethacrylate was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred and no clinical signs were noted. The mean body weight gain during the observation period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
The dermal LD50 value of 2 moles ethoxylated bisphenol A dimethacrylate in Wistar rats was established to exceed 2000 mg/kg body weight.
Justification for classification or non-classification
Based on the available data, no classification for acute toxicity is required for 2 modes ethoxylated bisphenol A dimethacrylate according to the Regulation EC N°1272/2008.
Justification : The oral and dermal LD50 are higher than 2000 mg/kg bw.
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