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EC number: 279-013-0 | CAS number: 78948-87-5
- 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
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- No Guideline stated in report. However, the methods used widely correspond to OECD 408 (1998) and OPPTS 870.3100 (EPA, 90-Day oral toxicity, rodents)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The methods used widely correspond to OECD 408 (1998) and OPPTS 870.3100 (EPA, 90-Day oral toxicity, rodents).
Deviations from current legislation were the following:
-Animals were dosed on 5 days per week (which is acceptable, but should have been justified in the study report).
-No assessments of motor activity, grip strength and sensory reactivity were conducted (no Guideline requirement in 1982)
-Not all remaining animals were terminally assessed, but 10 male and 10 females per group is sufficient to meet the Guideline requirements.
In haematology, no blood clotting parameters or platelet/reticulocyte counts were performed.
No adrenal, thymus and uterus weights were taken at necropsy.
Brain and spinal cord were not examined histopathologically at three section levels, but only at one level.
These minor deviations are not considered to have an impact on the validity or the scientific outcome of the study. There is no indication that the missing parameters play a role on the substance target organ toxicity. - GLP compliance:
- no
- Remarks:
- At the time the study was performed, GLP was not compulsory.
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Labs, (Wilmington, MA)
- Age at study initiation: 6 weeks
- Weight at study initiation: males 153-156 grams, females 125 -127 grams
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To: - Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- 28 days (interim sacrifice), 91 days (terminal sacrifice), no postexposure period
- Frequency of treatment:
- 5 days per week (65 doses)
- Dose / conc.:
- 12 mg/kg bw/day (nominal)
- Dose / conc.:
- 124 mg/kg bw/day (nominal)
- Dose / conc.:
- 620 mg/kg bw/day (nominal)
- Remarks:
- 620-1244: The high dose received 620 mg/kg for days 1-19, 1244 mg/kg for days 20-43 and 910 mg/kg for days 44-91
- No. of animals per sex per dose:
- 20 male and 20 female animals per group. 1 control, 3 dose groups
6 male and 6 female animals were randomly selected for interim sacrifice after 4 weeks (Day 29)
10 male and 10m female animals were selected for terminal sacrifice on day 92 to 93 - Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- Clinical signs: Yes (twice each day on 7 days per week)
Mortality: Yes (twice each day on 7 days per week)
Body weight: Yes (once weekly)
Food consumption: Yes (once weekly)
Water consumption: No
Ophthalmoscopic examination: Yes (prior to necropsy in each animal)
Haematology: Yes, number of animals: 6 males and 6 females prior to interim sacrifice, 10 males and 10 females per group at the end of the study
Parameters: haemoglobin, hematocrit, red blood count, white blood cell count, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, mean corpuscular volume and differential white blood cell count.
Clinical Chemistry: Yes, number of animals: 6 males and 6 females prior to interim sacrifice; 10 males and 10 females per group at the end of the study.
Parameters: magnesium, calcium, phosphorus, chloride, sodium, potassium, fasting glucose, SGPT (=ALT), SGOT (=AST), BUN, creatinine, albumin, total bilirubin, total serum protein
Urinalysis: Yes, number of animals: 6 males and 6 females prior to interim sacrifice; 10 males and 10 females per group at the end of the study.
Parameters: appearance, pH, specific gravity, glucose, protein, ketones, bilirubin, blood, deposits (by microscopy)
Faecal analyses: Once per week in 5 males and 5 females per group. Faecal pellets were analysed for occurrence of occult blood - Sacrifice and pathology:
- Organ Weights: Yes, number of animals: 6 males and 6 females per group at interim sacrifice; 10 males and 10 females per group at terminal sacrifice.
Organs: liver, kidney, heart, brain, ovaries or testes
Gross and histopathology: Yes, number of animals: 6 males and 6 females per group at interim sacrifice; 10 males and 10 females per group at terminal sacrifice.
High dose group and controls: lung, heart, aorta, tongue, trachea, oesophagus, thyroid, parathyroid, lymph nodes, stomach, liver, duodenum, jejunum, ileum, caecum, colon, urinary bladder, kidney, reproductive organs, adrenal, muscle, spleen, pancreas, bone with marrow, brain, spinal cord, sciatic nerve, salivary gland, pituitary gland, eyes, thymus, any lesions
Low and mid dose: liver, kidney, heart, lungs, stomach, duodenum, jejunum, ileum, caecum, colon - Other examinations:
- n.a.
- Statistics:
- Yes, at a p ≤ 0.05 level
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Low dose
12 mg/kg bw.: no overt signs of toxicity
Mid dose
124 mg/kg bw: chromodacryorrhea in one male and one female animal on individual days
High dose
620 mg/kg bw.: chromodacryorrhea in one male on day 19
1244 mg/kg bw.:chromodacryorrhea in four males on individual days; excess salivation in all animals; laboured breathing, diarrhea and decreased motor activity in a number of animals, but not in all
910 mg/kg bw.: salivation was most frequent in males and females; some incidences of chromodacryorrhea, diarrhea and rough coat in males - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Low dose
12 mg/kg bw.: 1 male ( day 52) and one female (day 30). Died due to natural death/false intratracheal administration; (both pre-terminal deaths unrelated to test item)
Mid dose
124 mg/kg bw: no pre-terminal deaths
High dose
620 mg/kg bw.: 1 male (day 7)
1244 mg/kg bw.:2 males (days 34, 42) and 1 female (day 28)
910 mg/kg bw.: 2 females (days 45, 52)
(In total, 6 of the high dosed animals died preterminally. It was assumed that 4 of the 6 deaths were attributable to the high dose level. There were no signs of toxicity preceding deaths) - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- No effects in female rats. In high-dosed males, bodyweights were significantly reduced during the second half of the study during most weeks.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption in females was significantly decreased from the third study week onwards, when the dose was increased from 620 to 1244 mg/kg bw.
After week 6, when the dose was decreased to 910 mg/kg bw., food consumption returned to normal.
In males a similar pattern was observed, however, food consumption did not return to normal after dose decrease. - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver weights were significantly increased in mid and high dosed females after 28 days and in the female high dose group at termination.
Relative kidney weights increased significantly in males and females at termination. (The increase in absolute weights only after 4 weeks in mid and high dosed animals was not dose-related and therefore not considered treatment-related). - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 124 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Due to the minor and reversible effects in the females at 124 mg/kg bw, this dose level can be considered as non adverse. Thus the overall NOAEL would be 124 mg/kg bw.
- Critical effects observed:
- no
- Conclusions:
- In a study performed under GLP and widely complies to current Guidelines such as OECD 408 and US EPA (OPPTS 870.3100, 90-day oral toxicity in rodents) Wistar derived rats (20 males and 20 females per group) were administered the test substance over 91 days. The animals were dosed 5 days per week by oral gavage at 3 dose levels. Due to minor and reversible effects in the females at 124 mg/kg bw, this dose level can be considered as non adverse. Thus the overall NOAEL was set with 124 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 124 mg/kg bw/day
- Study duration:
- subchronic
- 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
Justification for classification or non-classification
Based on the available data no classification is warranted.
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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