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EC number: 404-110-3 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Mutagenic properties of Pigmentadditiv RL (target substance) and/or PV 23 (source substance)were investigated in two bacterial reverse mutation assays (tester strains used: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100, TA 1538, E. coli WP2 uvr A), in an in vitro mammalian cell gene mutation test (HPRT) (Chines hamster lung fibroblasts, V79), and in an in vivo mammalian erythrocyte micronucleus test (NMRI mice, oral).
Negative results were obtained in all studies of the entire test battery for the target and the source substance. ThusPigmentadditiv RLis considered not to have genotoxic properties.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 474) according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- other: NMRI, strain NMRKf (SPF71)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund , SPF breeding colony
- Age at study initiation: 7 weeks
- Weight at study initiation: males: 30.1 g (26 g-34 g), females: 23.8 g (20 g-27 g)
- Housing: fully air-conditioned rooms in Macrolon cages (type 3), on softwood granulate in groups of 5 animals
- Diet: rat/mice diet Altromin 1324, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/-10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: sesame oil
- Concentration of test material in vehicle: 25%
- Amount of vehicle: 10 mL/kg bw (controls); 2 x 10 mL/kg bw (dose groups) - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: 6250 mg of test compound were weight in a breaker, mixed with sesame oil, washed out in a 25 mL flask and topped up to the calibration mark. A suspension was formed.
- Duration of treatment / exposure:
- The animals were killed 24, 48 or 72 h after administration (test compound and negative control) and 24 h after administration (positive control).
- Frequency of treatment:
- The test article was admistered in two equal parts within two hours
- Remarks:
- Doses / Concentrations:
0 mg/kg bw
Basis:
actual ingested - Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis:
actual ingested - No. of animals per sex per dose:
- 5 males and 5 females per time point
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide-Endoxan (Charge 107480) (50 mg/kg bw) was used as standard mutagenic substance. It was put in solution using water as vehicle. A 2% stock solution was prepared. Animals treated with the positive control via gavage were sacrificed 24 h after exposure.
- Tissues and cell types examined:
- bone marrow of femurs
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Oral administration of 5000 mg test substance per kg bw did not lead to a partial lethality in male and female mice (6 animals). It was considered the maximal applicable dose and was selected as dose level for the main study.
DETAILS OF SLIDE PREPARATION:
The proximal ends of the femora were opened and the bone marrow flushed into the centrifuge tube. After centrifugation and resuspension of the cells the smears were prepared: One drop of the mixed sedimet was smeared on a cleaned slide and dried for 24 h. The slides were stained with May-Grünwald-Giemsa.
METHOD OF ANALYSIS:
Microscopic examination of the slides was performed. For each animal 1000 polychromatic erythrocytes were examined. The number od cells with micronuclei was recorded. As a control measure 1000 mature erythrocytes were also counted and examined for micronuclei. At the same time the ratio of polychromatophile erythrocytes to normochromatophile erythrocytes was established. - Evaluation criteria:
- A possible statistically significant increase as compared to the controls and the possible deviation from the normal range of the negative control groups were used as evaluation criteria to discriminate between positive and negative results. Measurement parameters used: incidence of micronuc lea ted pol ychromatic erythrocytes, number of normochromatic erythrocytes with micro nuclei, the ratio of polychromat ic erythrocytes to normocytes
- Statistics:
- Wilcoxon (paired, two sides)
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- Faeces were blue coloured
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- - no significant increase of the number of polychromatic erythrocytes bearing micronuclei in test groups at any time point
- the number of normochromatic erythrocytes with micronuclei did not differ significantly from the values of the simultaneous control animals at any time point
- no marked decrease in the polychromatic erythrocytes / normochromatic erythrocytes ratio, i.e. no toxic effects in test and control group
- positve control was valid - Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of this study, the test item did not lead to a substantial increase of micronucleated polychromatic erythrocytes. - Executive summary:
The possible genotoxicity of the test item was examined in a micronucleus test in vivo according to OECD guideline 474 and GLP. The test compound was dosed orally per gavage at 0 and 5000 mg/kg bw to mice, based upon the results of a dose range finding assay (vehicle: sesame oil). The test compound was given in two equal parts within two hours. In accordance with the test procedure the animals (5 males and 5 females per dose group and examination time) were killed 24, 48 or 72 hours after administration. Cyclophosphamide (Endoxan) was used as positive control substance at a dose of 50 mg/kg bw. No statistically significant increase of micronucleated polychromatic erythrocytes has been observed. The number of normochromatic erythrocytes with micronuclei did not differ from the values of the simultaneous control animals for each of the three killing times investigated. The ratio of polychromatic erythrocytes to normocytes remained essentially unaffected by the test compound and was statistically not different from control values. The positive control induced a marked and statistically significant increase of the number of polychromatic erythrocytes with micronuclei in both males and females, indicating the sensitivity of the test system. Under the conditions of this study, the test item did not induce micronuclei in mouse bone marrow after oral exposure to 5000 mg/kg bw.
Reference
No signs of toxicity have been observed in the pretest and main study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
read across hypothesis and justification attached at corresponding robust study summaries of the target substance
Justification for selection of
genetic toxicity endpoint
Evaluation of genetic toxicity is
based on a battery of different study protocols comprising in the case
of consideration 4 studies with acceptable reliability (Klimisch 1 or 2):
- KEY_471_1989_Hoechst_89.1482, Bacterial Reverse Mutation Assay (Ames
test)
- RA_PV23_NON_KEY_471_AMES_2005_RCC_851202, Read Across, Bacterial
Reverse Mutation Assay (Ames test)
- RA_PV23_KEY_476_HPRT_2008_RCC_1136701, Read Across, In Vitro Mammalian
Cell Gene Mutation Assay (HPRT)
- KEY_474_1989_Hoechst_89.1034, In Vivo Micronucleus Assay
Short description of key
information:
Bacterial Reverse Mutation Assay (Ames
test): negative
Read Across (PV23), Bacterial Reverse Mutation Assay (Ames test):
negative
Read Across (PV23) , In Vitro Mammalian Cell Gene Mutation Assay (HPRT):
negative
In Vivo Mammalian Erythrocyte Micronucleus Assay: negative
Endpoint Conclusion:
No adverse effect observed (negative)
Justification for classification or non-classification
Based on the negative results in two bacterial reverse mutation studies, an in vitro mammalian cell gene mutation test, and an in vivo mammalian erythrocyte micronucleus test the submission substance has not to be classified for genotoxic effects according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC.
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