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EC number: 404-910-2 | CAS number: 164578-14-7 PIGMENT ADDITIV C
- 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
A 28 day oral toxicity in male and female rats up to 1000 mg/kg bw/d lead to no substance related effects. The NOEL was considered to be 1000 mg/kg bw/.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hoe:WISKf
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 weeks
- Weight at study initiation:
males: 127 g (mean)
females: 124 g (mean)
- Housing:
in fully air-conditioned rooms in Macrolon cages type 3, on softwood granulate in groups of 5 animals
- Diet (e.g. ad libitum): rat/mice diet Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum (except period in which animals were housed in metabolism cages)
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum (except period in which animals were housed in metabolism cages)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 50+/-20%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 2. Nov To: 30.Nov. 1989 - Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- - PREPARATION OF DOSING SOLUTIONS:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): homogenity of suspension
- Concentration in vehicle:
62.5 mg/kg bw/d: 1.25% (w/v)
250 mg/kg bw/d: 5% (w/v)
1000 mg/kg bw/d: 20% (w/v)
- Amount of vehicle (if gavage): 5 mL/kg bw - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
- Dose / conc.:
- 62.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
- Rationale for animal assignment (if not random): n.a., randomised
- Post-exposure recovery period in satellite groups: none, not required since no effects occurred - Positive control:
- none
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: twice weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, food consumption/100 g bw/d
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: weekly
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at study termination
- Anaesthetic used for blood collection: Yes, nembutal
- Animals fasted: No
- How many animals: all
- Parameters checked:
erythrocyte count, haemoglobin, haematocrit, leucocyte count, thromobcyte count, differential blood cell count, reticulocyte count, Heinz corpuscular count, coagulation time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at study termination
- Animals fasted: No
- How many animals: all
- Parameters checked:
sodium, otassium, inorganic phosphorus, uric acid, creatinine, glucose, urea, calcium, chloride, alanine aminotransferase (ALAT), aspartate-aminotransferase (ASAT), alkaline phosphatase, gamma-glutamyl peptidase, protein, albumin, globuline
URINALYSIS: Yes
- Time schedule for collection of urine: from day 26 to 27 overnight
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked:
appearance, color, pH, haemoglobin, protein, glucose, keton bodies, bilirubine, urobilirubine, density, dediment
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ weight: heart, lung, liver, kidneys, spleen, testis, epididymis
HISTOPATHOLOGY: Yes
heart, lung, liver, kidneys, spleen, stomach, jejunum, colon, thymus, testis, epidiymis, bone marrow (femur) - Statistics:
- body weight, body weight gain, haematology, clinical chemistry, absolute and relative organ weight, pH and specific gravity of urine
- 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):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- males:
decreased bilirubine at 1000 mg/kg bw/d. However, since the value is above the bilirubine measured in control and low dose females this decreased is considered to be non-treatment-related - Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Absolute weight of testes was decreased in high dose males. However, since the weights were still within the physiological normal range this decrease is considered to be not of biological relevance.
Lung weights were decreased in mid and high dose females. This effect did not follow a dose-response relationship, thus it is not considered as treatment-related. - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no treatment-related effects observed
- Key result
- Critical effects observed:
- no
- Conclusions:
- Based on the results of the 28 day oral toxicity study and the absence of effects the NOEL is derived at 1000 mg/kg bw/d.
- Executive summary:
The aim of this study was to assess the possible health hazards which could arise from repeated exposure of the substance via oral administration to rats over a period of 28 days.
The test item was administered daily in graduated doses to 3 groups of test animals, one dose level per group for a treatment period of 28 days. Animals of an additional control group were handled identically as the dose groups but received sesame oil, the vehicle used in this study. The 4 groups comprised of 5 male and 5 female Wistar rats.
During the period of administration, the animals were observed precisely each day for signs of toxicity. At the conclusion of the test, surviving animals were sacrificed and observed macroscopically and microscopically.
Body weight and food consumption were measured twice weekly, the water consumption onece weekly. At study termination urainlysis, heamtology and clinical chemistry was performed in all animals.
At the conclusion of the treatment period all animals were sacrificed and subjected to necropsy. The wet weight of a subset of tissues was taken and a set of organs/tissues was preserved.
A histopathological evaluation of the tissues was performed on all animals.
The following doses were evaluated:
Control: 0 mg/kg body weight
Low Dose: 62.5 mg/kg body weight
Medium Dose: 250 mg/kg body weight
High Dose: 1000 mg/kg body weight
The test item formulation was prepared freshly on each day of administration. Dose volumes were adjusted individually based on weekly body weight measurements.
No test item related effects were observed in all animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- reliable without restrictions
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
Mode of Action Analysis / Human Relevance Framework
In the absence of any evidence for species specific effects or modes of action the effects observed in animals are regarded as relevant for humans.
Additional information
An OECD 407 with the test substance was performed in rats.
The test item was administered daily in graduated doses to 3 groups of test animals, one dose level per group for a treatment period of 28 days. Animals of an additional control group were handled identically as the dose groups but received sesame oil, the vehicle used in this study. The 4 groups comprised of 5 male and 5 female Wistar rats.
During the period of administration, the animals were observed precisely each day for signs of toxicity. At the conclusion of the test, surviving animals were sacrificed and observed macroscopically and microscopically.
Body weight and food consumption were measured twice weekly, the water consumption onece weekly. At study termination urainlysis, heamtology and clinical chemistry was performed in all animals.
At the conclusion of the treatment period all animals were sacrificed and subjected to necropsy. The wet weight of a subset of tissues was taken and a set of organs/tissues was preserved.
A histopathological evaluation of the tissues was performed on all animals.
The following doses were evaluated:
Control: 0 mg/kg body weight
Low Dose: 62.5 mg/kg body weight
Medium Dose: 250 mg/kg body weight
High Dose: 1000 mg/kg body weight
The test item formulation was prepared freshly on each day of administration. Dose volumes were adjusted individually based on weekly body weight measurements.
No test item related effects were observed in all animals.
Justification for classification or non-classification
Due to the NOEL of 1000 mg/kg bw/day in an OECD 407 repeated dose toxicity study in rats the substance has not to be labelled according to the criteria laid down in the 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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