Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 412-550-2 | CAS number: 85776-14-3 GRAPHTOL ORANGE 3RT; PERMANENT ORANGE 2 RLD; PERMANENT ORANGE 3 RTN
- 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
Additional information
Discussion
Pigment Orange 74 did not induce gene mutations by frameshifts or base-pair substitutions in the genome of the strains used when tested in a bacterial reverse mutation assay (Ames test Prival modification, test strains: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2) with and without metabolic activation (rat liver S9 mix, and hamster liver S9 mix) at concentrations up to 5000 µg/plate.
Pigment Orange 74 didn't cause structural chromosomal aberrations when tested in the in vitro mammalian chromosome aberration test using Chinese hamster lung fibroblasts, neither with nor without metabolic activation at concentrations up to 50.2 µg/ml.
Pigments with similar chemical structure (PR 112, PR 146, PR 147, PR 170) were not genotoxic in the mammalian cell gene (HPRT) mutation test in V79 Chinese Hamster cells when tested with and without rat liver S9 metabolic activation.
In conclusion the test items did not induce gene mutations in bacteria or mammalian cells and didn't cause structural chromosomal aberrations in mammalian cells.
Read across justification
The purpose of this assessment is to provide justification for read across in order to predict the potential genetic and reproductive toxicity of the target substance Pigment Orange 74 based on available date coming from a set of source substances (Pigment Red 22, 112, 146, 147, 179).
The pigments used for read across are structurally similar and differ only by different substituents in the common core molecule. Target and source substances are solids which decompose or melt at high temperatures (>= 237°C). Solubility in water or n-octanol is very low or low (< 12 μg/L and < 3.4 mg/L, respectively). For the target substance solubility in water was determined to be below the limit of detection (<0.1 mg/L) and in n-octanol 0.16 mg/L. These values suggest poor absorption and low bioavailability for all pigments involved in this evaluation. The log n-octanol-water partition coefficients are in the range of 1.28 to 2.5 for all of the source pigments which fit together with log n-octanol-water partition coefficient of Pigment Orange 74 (>0.2). These values are far below the limit of concern considered to be critical for bio-accumulative properties. All pigments showed very limited biodegradability, which is assumed to be due to their unavailability for microorganisms. Lacking bioavailability is probably also the reason for the absence of any relevant mammalian toxicity: None of the source pigments showed any toxic effects after single oral or dermal or after repeated oral exposure including effects on reproductive performance (examined for Pigment Red 22 and 170). This pertains also for the target substance with the exception of one death in association with lung coloration observed after single oral application (2000 mg/kg bw) which might be attributed to incorrect dosing or inhaling of foamed vomit. A spontaneous not treatment related death cannot be ruled out as well. This seems not unlikely in view of the fact that no such effects were observed in an oral repeated dose study. Target and source pigments have no skin sensitising effects. All pigments are not mutagenic in the Bacterial Reverse Mutation Assay or the Mammalian Chromosomal Aberration Test. Negative results were also obtained for the source substances in the In vitro Mammalian Cell Gene Mutation Test (HPRT).
Due to the very low solubility of the pigments it can reasonably be assumed that the members of this read across approach are (nearly) not present in a dissolved form on the skin or mucous membranes after dermal, oral or inhalative exposure, i.e. they could not be absorbed via skin and mucous membranes. This conclusion is supported by the observation that the pigments evaluated do not exert any relevant toxicity.
This assessment is based on experimental data on the source pigments as compared to available data of the target pigment covering the following endpoints: Acute oral or dermal toxicity, skin and eye irritation, skin sensitisation, genotoxicity in vitro, subacute oral toxicity, toxicity to reproduction, and inherent biodegradability (for details see data matrix below).
In conclusion, the similar structure and the uniformity of physicochemical, environmental fate and toxicological properties justifies the application of read across to predict the outcome of a Developmental/Reproduction Screening Test and an In Vitro Mammalian Cell Gene Mutation Test (HPRT) of the target pigment based on available date coming from several source pigments. The minor differences in the structure do not significantly alter the basic physicochemical properties or the basic biological effects.
Data Matrix
CHEMICAL NAME |
Pigment Orange 74 |
Pigment Red 22 |
Pigment Red 112 |
Pigment Red 146 |
Pigment Red 147 |
Pigment Red 170 |
Role |
Target Substance |
Source Substance |
Source Substance |
Source Substance |
Source Substance |
Source Substance |
CAS No. |
85776-14-3 |
6448-95-9 |
6535-46-2 |
5280-68-2 |
68227-78-1 |
2786-76-7 |
PHYSICAL AND CHEMICAL PROPERTIES |
||||||
State of the substance at 20° C and 101,3 kPa |
orange solid |
red solid |
red solid |
red solid |
red solid |
red solid |
Melting/freezing point |
>= 278.2°C, |
decomp. starting at 237°C, 534 J/g |
decomp. starting at 270°C, 300 J/g |
decomp. starting at 283°C, 418 J/g |
decomp. starting at 278°C, 92 J/g |
decomp. starting at 313°C, 80 J/g |
Water solubility |
< 0.1 mg/L (below the detection limit) |
11.8 μg/L |
9.80 μg/L |
8.7 μg/L |
10 μg/L |
11.9 μg/L |
n-Octanol solubility |
0.16 mg/L
0.192 |
1.80 mg/L |
3.31 mg/L |
0.100 mg/L |
0.74 mg/l |
0.225 mg/L |
log Partition coefficientn-octanol/water |
> 0.2 (exact value could not be determined because water solubility was below the detection limit) |
2.18 |
2.5 |
1.87 |
1.87 |
1.28 |
Stability in organic solvents and identity of relevant degradation products |
>72 h in DMSO and 1,2-propylene glycol |
>72h in DMSO and 1,2-propylene glycol |
>72h in DMSO and sesame oil |
>72h in DMSO and 1,2-propylene glycol |
>72h in DMSO and 1,2-propylene glycol |
>72h in DMSO and 1,2-propylene glycol |
TOXICOLOGICAL INFORMATION |
||||||
Skin irritation |
not irritating |
not irritating |
not irritating |
not irritating |
not irritating |
not irritating |
Eye irritation |
not irritating |
not irritating (read across) b |
not irritating |
not irritating |
not irritating |
not irritating |
Skin sensitization |
not skin sensitising |
not skin sensitising (read across) |
not skin sensitising |
not skin sensitising |
not skin sensitising |
not skin sensitising |
In vitrogene mutation study in bacteria |
not mutagenic |
not mutagenic |
not mutagenic |
not mutagenic |
not mutagenic |
not mutagenic |
In vitrocytogenicity study in mammalian cells |
not mutagenic (CA in V79 cells) |
not mutagenic (CA in V79 cells) |
not mutagenic (MN in V79 cells) |
not mutagenic (CA in V79 cells) |
not mutagenic (CA in V79 cells) |
not mutagenic (CA in V79 cells) |
In vitrogene mutation study in mammalian cells |
RA-conclusion: not mutagenic (HPRT in V79 cells) |
not mutagenic (read across) |
Applied Source Substance: not mutagenic (HPRT in V79 cells) |
Applied Source Substance: not mutagenic (HPRT in V79 cells) |
Applied Source Substance: not mutagenic (HPRT in V79 cells) |
Applied Source Substance: not mutagenic (HPRT in V79 cells) |
Otherin vivomutagenicity tests |
No data requirement |
not mutagenic (read across) |
not mutagenic (read across) |
not mutagenic (read across) |
not mutagenic (UDS in vivo) |
not mutagenic (read across) |
Acute toxicity, oral route, (LD50 mg/kg b.w., rats) |
> 2000 |
> 2000 |
> 5000 |
> 10000 |
> 2000 |
> 15000 |
Acute tocity, inhalation (LC50 mg/L, rats ) |
Waiving (according to REACH Annex VIII, no.8.5, column 2; data for 2 application routes of acute toxicity available) |
Waiving (according to REACH Annex VIII, no.8.5, column 2; data for 2 application routes of acute toxicity available) |
Waiving (according to REACH Annex VIII, no.8.5, column 2; data for 2 application routes of acute toxicity available) |
Waiving (according to REACH Annex VIII, no.8.5, column 2; data for 2 application routes of acute toxicity available) |
Waiving (according to REACH Annex VIII, no.8.5, column 2; data for 2 application routes of acute toxicity available) |
Waiving (according to REACH Annex VIII, no.8.5, column 2; data for 2 application routes of acute toxicity available) (>1580 mg/m3/4h; RL3) |
Acute toxicity dermal route (LD50 mg/kg b.w., rat) |
> 2000 |
> 2000 |
> 5000 |
> 2000 |
> 2000 |
> 2000 |
Short-term repeated dose toxicity study in rats (oral) |
NOAEL 1000 mg/kg bw (highest dose tested; OECD 407) |
NOAEL 1000 mg/kg bw (highest dose tested; OECD 422) |
NOAEL 1000 mg/kg bw (highest dose tested; OECD 407) |
NOAEL 1000 mg/kg bw (highest dose tested; OECD 407) |
NOAEL 1000 mg/kg/day (read across) |
NOAEL ca. 1200 mg/kg bw (highest dose tested; OECD 407) |
Sub-chronic toxicity study in rats (oral) |
waiving (Annex XI: scientifically unjustified, because substances are not bioavailable and show no toxic effects in acute and short-term repeated dose studiesàpredicted not to be toxic after long-term repeated exposure) |
waiving (Annex XI: scientifically unjustified, because substances are not bioavailable and show no toxic effects in acute and short-term repeated dose studiesàpredicted not to be toxic after long-term repeated exposure) |
waiving (Annex XI: scientifically unjustified, because substances are not bioavailable and show no toxic effects in acute and short-term repeated dose studiesàpredicted not to be toxic after long-term repeated exposure) |
waiving (Annex XI: scientifically unjustified, because substances are not bioavailable and show no toxic effects in acute and short-term repeated dose studiesàpredicted not to be toxic after long-term repeated exposure) |
Waiving (Annex XI: scientifically unjustified, because substances are not bioavailable and show no toxic effects in acute and short -term repeated dose studiesàpredicted not to be toxic after long-term repeated exposure) |
Waiving (Annex XI: scientifically unjustified, because substances are not bioavailable and show no toxic effects in acute and short-term repeated dose studiesàpredicted not to be toxic after long-term repeated exposure) |
Carcinogenicity |
No data requirement |
No data requirement |
No data requirement |
No data requirement |
No data requirement |
No data requirement |
Screening for reproduction/developmental toxicity, rats |
RA-conclusion: NOAEL 1000 mg/kg bw |
Applied Source Substance: NOAEL 1000 mg/kg bw (highest dose tested; OECD 422) |
NOAEL 1000 mg/kg/day |
NOAEL 1000mg/kg/day |
NOAEL 1000 mg/kg/day |
Applied Source Substance: NOAEL 1000 mg/kg bw (highest dose tested; OECD 421) |
Toxicokinetic behaviour |
Available data point to inert behavior and non-bioavailability |
Available data point to inert behavior and non-bioavailability |
Available data point to inert behavior and non-bioavailability |
Available data point to inert behavior and non-bioavailability |
Available data point to inert behavior and non-bioavailability |
Available data point to inert behavior and non-bioavailability |
ENVIRONMENTAL FATE |
||||||
Inherent biodegradability |
Not readily biodegradable |
Not inherently biodegradable (read across) |
Not inherently biodegradable (read across) |
Not inherently biodegradable (read across) |
Not inherently biodegradable (read across) |
Not inherently biodegradable (read across) |
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:
KEY_471_Prival_2014_Harlan_1608600, Bacterial Reverse Mutation Test Prival Modification
KEY_473_1993_HAZLETON_15576_0_437C0, In vitro Mammalian Chromosome Aberration Test
RA_PR112_KEY_476_HPRT_2008_RCC_1154200, Read Across, In vitro Mammalian Cell Gene Mutation Test, HPRT
RA_PR146_KEY_476_HPRT_2008_RCC_1136801, Read Across, In vitro Mammalian Cell Gene Mutation Test, HPRT
RA_PR147_KEY_476_HPRT_2007_RCC_1075800, Read Across, In vitro Mammalian Cell Gene Mutation Test, HPRT
RA_PR170_KEY_476_HPRT_2008_RCC_1136601, Read Across, In vitro Mammalian Cell Gene Mutation Test, HPRT
Short description of key information:
Mutagenic properties of Pigment Orange 74 were investigated in a bacterial reverse mutation assay (Prival modification; tester strains used: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2), an in vitro mammalian chromosome aberration test (Chinese hamster lung fibroblasts (V79)), and additionally in 4 in vitro Mammalian Cell Gene Mutation Tests, HPRT, which were performed with pigments of similar chemical structure (RA, Chinese hamster lung fibroblasts (V79)).
Negative results were obtained in all studies of the entire test battery.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Pigment Orange 74 did not reveal mutagenic effects in the bacterial reverse mutation assay and did not cause chromosomal aberrations in the in vitro mammalian chromosome aberration test. 4 Pigments with similar chemical structure were not genotoxic in mammalian cell gene (HPRT) mutation tests.
Therefore Pigment Orange 74 is considered not to be mutagenic and does not have to be classified for mutagenicity according to the criteria laid down in Directive 67/548/EEC and in 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
