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EC number: 400-600-6 | CAS number: 71868-10-5 ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
- EC Number:
- 400-600-6
- EC Name:
- 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
- Cas Number:
- 71868-10-5
- Molecular formula:
- C15 H21 N O2 S
- IUPAC Name:
- 2-methyl-1-[4-(methylsulfanyl)phenyl]-2-(morpholin-4-yl)propan-1-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF), F3-hybrid of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Production CIBA-GEIGY LTD., Switzerland
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: 187-193 g in males; 169-174 g in females
- Housing: in groups of five animals
- Diet (e.g. ad libitum): Pelleted, certified standard diet Nafag No. 890 Tox, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum.
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55± 10
- Air changes (per hr): 16-20
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: carboxymethyl-cellulose 0.5 % with 0.1 % Tween 80
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The solutions were freshly prepared every day immediately prior to the dosing of the animals and administered within 2 hours.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytically performed stability test of February 4, 1983 by the analytical Services R of CIBA-GEIGY Ltd. revealed that the test substance remains stable during 4 hours in the vehicle (analytical method KS-52/1).
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 30, 100, 300 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 animals
- Control animals:
- yes, concurrent vehicle
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: mortality, symptoms
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly (midweek)
FOOD CONSUMPTION:
- Time schedule for examinations: weekly
- Food consumption ratio: calculated according to the following formula: (weekly food consumption (g) x 1000)/(midweek body weight (g))
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the end of the treatment period. To reduce the biological variability due to circadian rhythms, blood sampling for haematology and blood chemistry was performed between the hours of 07:00 and 11:00 a.m.
- Anaesthetic used for blood collection: Ether
- Animals fasted: Yes, food was withheld for about 20 hours prior to blood removal.
- Parameters checked: Erythrocytes, Leucocytes, Haemoglobin, Haematocrit, Differential Count (Blood smear stained with a modified polychrome methylene blue (Ames, Hema-Tek Stain-Pak)), Metamyelocytes, Band Neutrophils, Segmented Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes, Plasma Cells, Nucleated erythocytes, Nucleated RBC-Erythroblasts, Reticulocytes, Supravital staining with brilliant cresyl blue, Inclusion bodies (Heinz bodies), Supravital staining with brilliant cresyl blue, Prothrombin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of the treatment period. To reduce the biological variability due to circadian rhythms, blood sampling for haematology and blood chemistry was performed between the hours of 07:00 and 11:00 a.m.
- Animals fasted: Yes, food was withheld for about 20 hours prior to blood removal.
- Parameters checked: Urea, Total Protein, Albumin, A/G Ratio, Aspartate Aminotransferase, Alanine Aminotransferase, Total Bilirubin, Creatinine - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, organ weights (adrenals, brain, kidneys, liver, testes)
HISTOPATHOLOGY: Yes, skin, mammary area, spleen, mesenteric lymph node, axillary lymph node, sternum with bone marrow, femur with joint, skeletal muscle, trachea, lung, heart, aorta, submandibular salivary gland, liver, pancreas, oesophagus, stomach, small intestine, large intestine, kidney, urinary bladder, prostate, seminal vesicle, testis, epididymis, uterus, ovary, pituitary gland, adrenal gland, thyroid with parathyroid gland, thymus, peripheral nerve, brain, spinal cord, eye with optic nerve, orbital gland, extraorbital lacrimal gland, organs and tissues showing macroscopical changes.
- ADDITIONAL HISTOPATHOLOGICAL EXAMINATION OF THE NERVOUS SYSTEM AND EYE:
- Time schedule for examinations: at the end of the test period
- Dose groups that were examined: all animals
- Battery of functions tested: Samples of the brain, the spinal cord, the peripheral (sciatic) nerve and the eyes - Statistics:
- An uni-variate statistical analysis was conducted. Each treated group was compared to the control group in respect of dispersion and displacement (Y. Lepage, Biometrika (1971) 58: pp. 213-217). In addition a trend test (H. R. Jonckheere, Biometrika (1954) 41: pp. 133-145) was applied considering all groups.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- In treated male and female animals of group 4 (300 mg/kg bw) marked signs of systemic intoxication were observed: diarrhoea, lameness of hindleg, locomotion altered, eyes, pale/opaque, ruffled fur, hairless, salivation, emaciated.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- One male died due to misapplication. Another male and two females of the high doe group died treatment related.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean body weight of treated male and female groups 3 and 4 (100 and 300 mg/kg bw.) was significantly depressed in a dose dependent manner, up to 33 %. The mean body weight of female group 2 (30 mg/kg bw.) was only slightly and not significantly depressed.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- The mean food consumption of treated male groups 3 and 4 (100 and 300 mg/kg bw) was depressed in a dose dependent manner.
Food consumption ratio was depressed in treated male and female groups 3 and 4 (100 and 300 mg/kg bw.), which was most prominent during week 1 to 2 of treatment in groups 4 (300 mg/kg bw). - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Hematology investigation during week 5 showed a moderate increase in numbers of red blood cells (RBC), a marked increase in haemoglobin concentration and in haematocrit in males receiving 300 mg/kg bw. In females receiving 300 mg/kg bw a moderate increase in numbers of white blood cells (WBC) was observed. In both males and females of the 300 mg/kg bw group, a slight decrease in numbers of lymphocytes and a slight increase in numbers of segmented neutrophils was seen.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Blood chemistry investigations during week 5 revealed slightly higher alanine aminotransferase (GPT) levels in both males and
females of the 100 and 300 mg/kg bw group, up to 2-fold. Aspartate aminotransferase (GOT) levels were also slightly increased in both sexes of the 300 mg/kg bw group. - Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The following findings were observed during autopsy examination in treated male and female animals of group 4 (300 mg/kg bw.): Acute congestion - sometimes with hemorrhages - in various parenchymatous organs in animals which succumbed during the test period.
Minimal focal acanthosis of the epidermis and atrophy of the hair follicles as well as slight focal inflammatory infiltration in the skin was observed in those 3 female animals previously noted for loss of hair during the in-life phase in group 4 (300 mg/kg bw). - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- The following findings were observed during histopathological examination in treated male and female animals of groups 4 (300 mg/kg bw.): Slight hypertrophy of the hepatocytes in 4 of 5 male and 2 of 5 female animals.
- Histopathological findings: neoplastic:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- histopathology: non-neoplastic
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- the 28 day repeat dose NOEL of the test material in rats was determined to be 30 mg/kg bw/day based upon bodyweight gain and food consumption under the conditions of the test.
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