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Diss Factsheets
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EC number: 701-373-9 | 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
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 900 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study on the read-across substance was conducted in CD rats in accordance with GLP and OECD guideline 422. Three groups each comprising five male and five female rats for the toxicity subgroup and five male and ten female rats for the reproductive subgroup received 4,4’-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid at doses of 100, 300 or 900 mg/kg bw/day. Toxicity subgroup males and females and reproductive subgroup males were treated daily for five consecutive weeks. Reproductive subgroup females were treated daily for two weeks before pairing, throughout pairing, gestation, and lactation until the day prior to termination on Day 7 of lactation. A similarly constituted control group received the vehicle, propylene glycol, at the same volume-dose.
During the study, data was recorded on clinical condition, performance under detailed physical and arena examination, sensory reactivity, grip strength, motor activity, bodyweight, food consumption, water consumption (visual), haematology, blood chemistry, oestrous cycles, mating performance, and fertility and gestation length. Organ weight, macroscopic, and microscopic pathology investigations were undertaken in the adults. The clinical condition of offspring, litter size and survival, sex ratio, and offspring bodyweight were assessed and macroscopic pathology investigations were undertaken.
There was only one mortality during the course of the study, therefore considered unrelated to treatment. There were no signs observed among treated males and females at the routine physical examination or during the arena observations that were considered to be related to treatment. There was no effect of treatment on the food consumption, sensory reactivity findings, grip strength values, and motor activity in males and females throughout the study.
At 900 mg/kg bw/day, the mean bodyweight gain of males was slightly lower than control during the first week of treatment. During the second week, weight gain for these males remained slightly (but not significantly) lower than control, but thereafter, mean weight gain was essentially similar to control in all treated groups, and the bodyweight gain of females during gestation and lactation was unaffected by treatment at all dose levels investigated.
Haematological assessment revealed slightly prolonged prothrombin time among males and females receiving 900 or 300 mg/kg bw/day. Biochemical changes in the blood plasma comprised high total bilirubin and total bile acid concentrations in males receiving 900 or 300 mg/kg bw/day and females receiving 900 mg/kg bw/day, and high cholesterol concentrations in males and females in all treated groups. A dose-related trend was evident for all of these haematological and biochemical parameters.
There was no clear evidence of an adverse effect of treatment on mean organ weights among all animals at scheduled termination. There were no macroscopic abnormalities and no test substance-related lesions at microscopic examination.
Oestrous cycle length, pre-coital interval, mating performance, and fertility and gestation length of the reproductive subgroup females were unaffected by treatment. There were no clinical signs observed for F1 offspring that were considered to be related to parental treatment and offspring survival and growth from birth to Day 7 of age were unaffected by treatment. There were no macroscopic abnormalities detected among the offspring that died during the early post-natal period, or at scheduled termination on Day 7 of age that were attributable to parental treatment.
Based on the results of this study, it was concluded that the NOAEL for systemic toxicity in the CD rat was 900 mg/kg bw/day (Stannard, 2010).
Justification for classification or non-classification
Based on the combined repeated dose and reproduction / developmental screening study conducted with the read-across substance, no classification is warranted according to the CLP Regulation (EC) no. 1272/2008.
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.
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