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EC number: 942-002-2 | 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
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:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 404-100-9
- EC Name:
- -
- IUPAC Name:
- 404-100-9
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 151 - 175 g; females: 152 - 179 g
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding ('Lignocel', Schill AG, 4132 Muttenz, Switzerland).
- Diet (e.g. ad libitum): Pelleted standard Kliba no. 343, Batches 35/88 and 36/88, rat maintenance diet
('Kliba', Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum.
- Water (e.g. ad libitum):Community tap water from Itingen was available ad libitum.
- Acclimation period: Seven days under laboratory conditions, after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, music/light period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test article was weighed into a glass beaker on a tared Mettler PE 360 balance and the vehicle, distilled water, was added. The mixture was prepared daily prior to administration using a homogenizer and kept stable during application with a magnetic stirrer. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not available
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Once daily, 7 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 200, 1000 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- 30 males
30 females - Control animals:
- not specified
- Details on study design:
- Rationale:
Based upon data received from acute studies and the conclusions drawn from a 5-day oral toxicity (range-finding) study (RCC Project 223694). In this study, individuals of both test groups (200 and 1000 mg test article/kg bw) showed bluish to greenish discoloration of various organs, but no other treatment-related abnormalities occurred. - Positive control:
- Not available
Examinations
- Observations and examinations performed and frequency:
- MORTALITY:
Observations for mortality were recorded once daily.
DETAILED CLINICAL OBSERVATIONS: Yes
Signs of toxicity were assessed once daily. Descriptions of all abnormalities were recorded and the subsequent progress was monitored
BODY WEIGHT: Yes
The body weight of each animal was recorded on the same days as the food consumption using the same recording system.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
The food consumption was recorded once during the acclimatization period and weekly thereafter using an on-line electronic recording system consisting of a
Mettler PK 4800 balance connected to the RCC computer.
OPHTHALMOSCOPIC EXAMINATION:
Ophthalmoscopic examinations were performed on all animals. A description of any abnormality was recorded. Examinations were performed at termination of
treatment and a second time on the recovery individuals of groups 1 and 4 at termination of the recovery period. Ten minutes after the application of a mydriatic solution (Dispersa AG, Winterthur / Switzerland) the cornea, lens, anterior chamber, vitreous body and ocular fundus of both eyes were examined under dimmed light using a Heine Miroflex 2 Ophthalmoscope (Eisenhut Vet. AG, Allschwil / Switzerland).
HAEMATOLOGY: Yes
The following anticoagulants were used during blood collection:
EDTA-K2 (hematology)
Sodium Citrate, 3.8% (coagulation, 1:10)
The following commercial reference controls were used to monitor the
performance of the method:
Hematology:
Eightcheck (normal range)
Eightcheck-L (lower abnormal range)
(TOA International Corporation, Kobe/Japan)
IL 282 CO-Oximeter Control
(Instrumentation Laboratory Inc., Lexington, Ma./USA)
Coagulation:
Ci-Trol-1 (normal range)
Ci-Trol-2 (high range)
(Merz & Dade AG, Duedingen/Switzerland)
19 - Sacrifice and pathology:
- ORGAN WEIGHTS
The following organ weights were taken from all animals necropsied at termination of treatment or recovery:
Liver; Kidneys; Adrenals; Testes.
NECROPSY AND HISTOPATHOLOGY
NECROPSY
Prior to necropsy, the animals were fasted for approx. 18 hours, but water was provided.
All animals were necropsied and descriptions of all macroscopic abnormalities were recorded. Necropsies were performed by experienced prosectors. All animals surviving to the end of the observation period were anesthetized by intraperitoneal injection of sodium pentobarbitone and killed by exsanguination.
after 4 weeks - February 7, 1989
after 6 weeks - February 21, 1989
Samples of the following tissues and organs were collected from all animals at necropsy and fixed in phosphate buffered neutral 4 % formaldehyde solution:
Adrenals; Aorta; Brain; Cecum; Colon; Duodenum; Epididymides; Esophagus; Eyes with optic nerve and Harderian gland; Female mammary gland area; Femur
including joint; Heart; Ileum; Jejunum; Kidneys; Larynx; Lacrimal gland, extraorbital; Liver; Lung infused with formalin; Lymph nodes, mandibular, mesenteric;
Nasopharynx; Ovaries; Pancreas; Pituitary gland; Prostate gland; Rectum; Salivary gland, mandibular, sublingual; Seminal vesicles; Sciatic nerve; Skeletal muscle; Skin; Spinal cord, cervical; Spleen; Sternum with marrow; Stomach; Testes; Thymus; Thyroid gland; Tongue; Trachea; Urinary bladder infused with formalin; Uterus with uterine cervix; Gross lesions.
HISTOTECHNIQUE / HISTOPATHOLOGY
The following tissues were trimmed, processed and embedded in paraffin wax and sectioned at a thickness of 2-4 micrometer: Adrenals, heart, kidneys, liver, spleen, lymph nodes, gastro-intestinal tract and gross lesions from all control and high dose animals, main test and recovery group.
Kidneys, liver, spleen lymph nodes, gastro-intestinal tract and gross lesions from the other treated groups. Sections were stained with haematoxylin and eosin and examined light microscopically. - Other examinations:
- Not available
- Statistics:
- he following statistical methods were used to analyze the body weights, food consumption, organ weights and clinical laboratory data : Univariate one-way analysis of variance was used to assess the significance of intergroup differences. If the variables could be assumed to follow a normal distribution, the Dunnetttest (many to one t-test) based on a pooled variance estimate was applied for the comparison between the treated groups and the control groups. The Steel-test (many-one rank test) was applied when the data could not be assumed to follow a normal distribution. For the ophthalmoscopic data, the Fisher's exact test for 2 x 2 tables was applied. Group means were calculated for continuous data and medians were calculated for discrete data (scores) in the summary tables.
Individual values, means, standard deviations and statistics were round-off before printing. For example, test statistics were calculated on the basis of exact values for means and pooled variances and then rounded-off to two decimal places. Therefore, two groups may display the same printed means for a given parameter, yet display different test statistics values.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Administration of the test article did not cause any death throughout this study.
From day 9 of treatment onwards, the faeces of animals of all test articletreated groups were dark blue discolored. Test animals of group 4 recovered from this abnormality within 7 days of abstinence from the test article.
BODY WEIGHT AND WEIGHT GAIN
Changes of the body weight or body weight gain which could be related to the treatment with test article did not occur.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
The rates of food consumption were not affected significantly by the test article administered.
FOOD EFFICIENCY
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
OPHTHALMOSCOPIC EXAMINATION
No treatment-related changes were seen on ophthalmoscopy.
HAEMATOLOGY
The assessment of hematological, biochemical and urinalysis data indicated no changes of toxicological significance at termination of the treatment nor at the end of the treatment-free recovery period.
ORGAN WEIGHTS
Administration of test article did not affect significantly the organ weights and organ/body weight ratios during the treatment period. No treatment-related effects of toxicological relevance occurred
HISTOPATHOLOGY
Many treated animals were found to have green discoloration of the gastrointestinal tract and in lymphoid tissue. In the great majority of cases the discoloration was not apparent microscopically. The staining of tissues is thought to represent an inherent property of the compound and should not be regarded as an expression of toxicity. There were no other treatment related findings identified.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: no adverse effects were seen
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The "no-observed-adverse-effect-level" of FAT 40'336/B is 1000 mg/kg bw for male and female rats when administered orally by gavage for a period of 28 days.
- Executive summary:
In this subacute 28-day toxicity study, FAT 40'336/B was administered daily by gavage to SPF-bred Wistar rats. The study was comprised of four groups.
The dose levels used in this study are based on data from acute studies and the conclusions drawn from a 5-day oral toxicity (range-finding) study (RCC Project 223694). In this study, individuals of both test groups (200 and 1000 mg test article per kg body weight) showed bluish to greenish discoloration of various organs, but no other treatment-related abnormalities occurred.
Based upon the results obtained in this study, the "no-adverse-effect-level" of FAT 40'336/B is 1000 mg/kg body weight for male and female rats when administered orally by gavage for a period of 28 days. Oral administration of FAT 40'336/B to rats for 28 days at the dose level of 1000 mg/kg body weight/day produced no toxicological, hematological, biochemical or pathological evidence of toxicity.
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