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EC number: 202-166-1 | CAS number: 92-55-7
- 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
Carcinogenicity
Administrative data
Description of key information
Supporting study: Carcinogenity (Morris 1969):
The carcinogenic activity of 5 -nitrofurfurylidene diacetate was evaluted. Female albino rats (5 and 13 rats, of 60 days and 22 days ages, in experiments 1 and 2) were exposed to 0.2% in diet for up to 44.5 weeks (33 and 44.5 weeks in experiments 1 and 2). An unexpectedly large number of animals died early in the experiments. The pathologic findings and the clinical experience that penicillin therapy almost completely controlled these deaths support the opinion that they were usually the result of overwhelming infections superimposed on chronic respiratory disease often seen in rat colonies. 4 mammary tumors were detected in Experiment 2. All mammary tumors were histologically benign. Three rats in the control group for Experiment 2 had mammary lesions too, 2 of which were clearly benign. One lesion was considered to be an atypical fibroadenoma. The atypical lesions always contained small areas suggestive of carcinoma, but the majority of the tumor was too well differentiated to be labeled as malignant. Based on these results, the test item did not show carcinogenic activity when administered to female rats at 0.2% in diet for up to 44.5 weeks.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- (only females, only one dose tested, 5 or 13 animals (experiment 1 or 2), 60 or 22 days (experiment 1 or 2), duration 36 and 44.5 weeks (experiment 1 or 2); few parameters reported, administration of penicillin)
- GLP compliance:
- no
- Specific details on test material used for the study:
- Chemical name: 5-nitro-2-furanmethanediol diacetate
Source: Eastman Organic Chemicals, Rochester, New York (USA) - Species:
- rat
- Strain:
- other: Holtzman albino rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Holtzman Rat Company, Madison, Wisconsin (USA)
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: Experiment 1: 60 days age / Experiment 2: 22 days of age
- Weight at study initiation: Experiment 1: 170-175 g / Experiment 2: 55-58 g
- Housing: 3 to 6 animals per cage (screen-bottomed)
- Diet (e.g. ad libitum): Ad libitum (Ground Wayne Lab-Blox (Allied Mills, Inc., Chicago, Illinois))
- Water (e.g. ad libitum): Ad libitum - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): Not specified.
- Mixing appropriate amounts with (Type of food): Test supplements were prepared by grinding the chemical and glucose together in a glass mortar in proportions such that the test diets could be prepared by the addition of 10 g of the triturate/kg of ration. The supplement and stock diet were then mixed thoroughly in an institutional food-mixing machine.
- Storage temperature of food: Diets were prepared in 5-kg quantities and stored at 8-12 C until needed.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Experiment 1: 36 weeks
Experiment 2: 44.5 weeks - Frequency of treatment:
- Daily
- Dose / conc.:
- 0.2 other: % in diet
- Remarks:
- Average (mg/day): Experiment 1 = 29 / Experiment 2 = 31
Total (g): Experiment 1 = 7.20 / Experiment 2 = 8.94 - No. of animals per sex per dose:
- Experiment 1: 5
Experiment 2: 12 - Control animals:
- yes, concurrent no treatment
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
The animals were inspected at least once and usually twice a day
DETAILED CLINICAL OBSERVATIONS: Yes
The rats were palpated approximately biweekly at the time of weighings to detect superficial tumors.
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
The partially emptied food containers were weighed for 3 days at least once every 3 weeks to permit calculation of the amount of chemical consumed.
FOOD EFFICIENCY: No data.
OPHTHALMOSCOPIC EXAMINATION: No data.
HAEMATOLOGY: No data.
CLINICAL CHEMISTRY: No data.
URINALYSIS: No data.
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
All animals were subjected to thorough postmortem examinations. The brain and the thoracic and abdominal viscera, including the lumen of the gastrointestinal tract and the lumen of the urinary bladder, were grossly examined.
HISTOPATHOLOGY: Yes
All tissues except the bladders were fixed in 10% formalin, 10% buffered formalin, or formalin acetic acid (2000 ml of distilled water, 1000 ml of 95% ethanol, 300 ml of formalin solution, and 50 ml of glacial acetic acid). All bladders were fixed in Bouin's solution. Specimens of all gross tumors, all bladders, and samples of the livers, kidneys, and spleens were embedded in paraffin, sectioned, and stained with hematoxylin and eosin. With the finding of evidence of respiratory infection, samples of lung tissue were examined microscopically. Other tissues with even slight gross evidence of abnormality were also examined microscopically. - Clinical signs:
- no effects observed
- Description (incidence and severity):
- The animals appeared to tolerate the drugs at the levels fed and had no toxic manifestations.
Survival was poor in all groups, including untreated control rats, until penicillin therapy was begun. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- An unexpectedly large number of animals died early in the experiments. The pathologic findings and the clinical experience that penicillin therapy almost completely controlled these deaths support the opinion that they were usually the result of overwhelming infections superimposed on chronic respiratory disease often seen in rat colonies.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- 4 mammary tumors were detected in Experiment 2. All mammary tumors were histologically benign. Probability that the observed result might have occurred by chance, as calculated by the exact method for 2 X 2 tables: 0.18.
Three rats in the control group for Experiment 2 had mammary lesions, 2 of which were clearly benign. One lesion was considered to be an atypical fibroadenoma. The atypical lesions always contained small areas suggestive of carcinoma, but the majority of the tumor was too well differentiated to be labeled as malignant. - Other effects:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 0.2 other: % in diet
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No adverse effects observed at highest dose tested
- Key result
- Critical effects observed:
- no
- Conclusions:
- The test item did not show carcinogenic activity when administered to female rats at 0.2% in diet for up to 44.5 weeks.
- Executive summary:
The carcinogenic activity of 5 -nitrofurfurylidene diacetate was evaluted. Female albino rats (5 and 13 rats, of 60 days and 22 days ages, in experiments 1 and 2) were exposed to 0.2% in diet for up to 44.5 weeks (33 and 44.5 weeks in experiments 1 and 2). The partially emptied food containers were weighed for 3 days at least once every 3 weeks to permit calculation of the amount of chemical consumed. The animals were inspected at least once and usually twice a day. The rats were palpated approximately biweekly at the time of weighings to detect superficial tumors. All animals were subjected to thorough postmortem examinations. The brain and the thoracic and abdominal viscera, including the lumen of the gastrointestinal tract and the lumen of the urinary bladder, were grossly examined. Specimens of all gross tumors, all bladders, and samples of the livers, kidneys, and spleens were embedded in paraffin, sectioned, and stained with hematoxylin and eosin. With the finding of evidence of respiratory infection, samples of lung tissue were examined microscopically. Other tissues with even slight gross evidence of abnormality were also examined microscopically. An unexpectedly large number of animals died early in the experiments. The pathologic findings and the clinical experience that penicillin therapy almost completely controlled these deaths support the opinion that they were usually the result of overwhelming infections superimposed on chronic respiratory disease often seen in rat colonies. 4 mammary tumors were detected in Experiment 2. All mammary tumors were histologically benign. Three rats in the control group for Experiment 2 had mammary lesions too, 2 of which were clearly benign. One lesion was considered to be an atypical fibroadenoma. The atypical lesions always contained small areas suggestive of carcinoma, but the majority of the tumor was too well differentiated to be labeled as malignant. Based on these results, the test item did not show carcinogenic activity when administered to female rats at 0.2% in diet for up to 44.5 weeks.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Study of Klimisch 3 (significant methodological deficiencies).
Justification for classification or non-classification
Based on available data, the subtance is not classified for carcinogenicity according to the Regulation 1272/2008.
Additional information
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