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EC number: 263-272-1 | CAS number: 61847-48-1
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 433 (Acute Inhalation Toxicity: Fixed Concentration Procedure)
- Principles of method if other than guideline:
- The test item dust aerosol was generated and injected at a specific rate into the inhalation chamber. Groups of animals of a single male sex were exposed for 4-hours period of time to the test chemical in a stepwise procedure using the appropriate fixed concentrations for dusts/mists (aerosols) as set out in Annex 1. As the rats were observed ‘evident toxicity’ rather than death/moribundity was used as an endpoint. Concentrations that were expected to be lethal were avoided.
The initial concentration level was selected on the basis of a sighting study at the concentrations of a 1mg/l and 5mg/L and there were no clinical signs were observed in the rats at this sighting study exposure concentration.
The rats were observed for effects in terms of toxic signs and pre-terminal deaths. The surviving rats at the end of the study were necropsied - GLP compliance:
- yes
- Test type:
- fixed concentration procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate
- EC Number:
- 263-272-1
- EC Name:
- Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate
- Cas Number:
- 61847-48-1
- Molecular formula:
- C33H24Cl2N4O6
- IUPAC Name:
- methyl 4-[(2,5-dichlorophenyl)carbamoyl]-2-({2-hydroxy-3-[(2-methoxyphenyl)carbamoyl]-1-naphthyl}diazenyl)benzoate
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- Name of test material (as cited in study report): Certificate of Analysis AZ653pc_specd1: Novoperm-Rot HF3S
Analytical purity: 95.3 % (w/w) (comp. 1)
Constituent 1
- Specific details on test material used for the study:
- Test Item Information (As furnished by the Sponsor)
Batch Manufactured By
(Name and Address) : Clariant Produkte (Deutschland) GmbH
Brueningstrasse 50
65929 Frankfurt am Main,
Germany
Batch Supplied By
(Name and Address) : Clariant Produkte (Deutschland) GmbH
Brueningstrasse 50
65929 Frankfurt am Main,
Germany
Test Item : Novoperm-Rot HF3S
Color Index (as per Certificate of Analysis) : Pigment Red 188
CAS NO. : 61847-48-1
Chemical Name (IUPAC) : Methyl4-[[(2,5-dichlorophenyl)-amino]-carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)-amino]-carbonyl]-1-naphthyl]-azo]-benzoate
Physical Appearance : Red powder
Purity as Certificate of Analysis : 95.3 % (w/w)
Batch No. : DEB2136860
Manufactured date : 08.11.2010
Expiry date : 08.11.2022
Recommended Storage Condition : Ambient (+15 to + 25°C)
Physico-chemical properties : pH : 5 to 8
Density: 1.47 g/mL
Water solubility: <0.02 mg/L
Note: 1. Date of receipt of test item at test facility: 19 October 2021
2. Test item code by test facility: C067-06
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Rats were housed individually per cage per sex for sighting study and for limit test in group of two / three per cage / sex in standard polysulfone cages (Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelletted food and drinking water. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and was changed along with the cage once a week.
Bedding: Steam sterilized corn cob was used and changed along with the cage once a week.
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Mass median aerodynamic diameter (MMAD):
- 2.35 µm
- Geometric standard deviation (GSD):
- 1.71
- Remark on MMAD/GSD:
- The value for Mass Median Aerodynamic Diameter (MMAD) 1-4 µm and geometric standard deviation (GSD) 1.5 to 3.0 for the test item were within the range for G1 group as recommended by OECD guidance document no. 39 on acute inhalation testing
- Details on inhalation exposure:
- The inhalation toxicity study of “Novoperm-Rot HF3S” was determined in 5 male Wistar rats by exposure to test item as a dust aerosol generated by dust generator with an air flow rate of 10 LPM and a piston speed of 92 mm/h with 200 kilopascals of atomizer pressure. The rats were housed in special rat restrainers and continuously exposed to the test item aerosol (nose only) for 4 hours in an inhalation exposure chamber (dynamic state) for the G1 group. The post treatment observation period was 14 days
- Duration of exposure:
- 4 h
- Concentrations:
- The average actual concentration of “Novoperm-Rot HF3S” was 5.05 mg/L of chamber air. The test item concentration at the animals’ breathing zone was determined using gravimetric filter analysis method
- No. of animals per sex per dose:
- 5
- Details on study design:
- Five male rats per group was assigned to main group for limit test, by body weight stratification during acclimatization. Animals with extreme body weights were not used for the study and excluded from the treatment.
Group allocation, piston speed and number of rats
Group Piston speed
(mm/h) Sex No. of
rats Rat Numbers
From To
G1
92
M
5
Rad3371
Rad3375
M: Male
Results and discussion
- Preliminary study:
- 8.2.5.1 Technical pre-test
The test item was made into fine powder using marshall mars mill and sieve.
A technical pre-test was conducted without animals to check the feasibility of generating adequate test atmosphere (Test item concentration, particle size distribution, O2, CO2, temperature and relative humidity) after chamber equilibrium. The chamber air actual concentration was estimated gravimetrically.
The exposure conditions and results of technical pre-test is given below at highest achieved actual test item concentration at breathing zone.
Technical pre-test exposure conditions:
Aerosol generation system Dust generator
Feeding air supply pressure 200 Kilopascals
Piston speed (mm/h) /Airflow rate (LPM) 92 / 10
Sampling duration 1 min
Sampling rate 4 LPM
Technical pre-test results:
Test item actual concentration
(mg/L of air) 5.02
MMAD (µm) & GSD 2.39 & 1.71
O2 content in % v/v 20.8
CO2 content in % v/v 0.03
Chamber temperature in °C 21.7
Relative humidity (%) 62.3
8.2.5.2 Sighting study
Sighting study I:
As no evidence from existing data on the same chemical and structurally related chemicals, hence as per Annex 1 the starting concentration 1 mg/L was selected for dust aerosol.
As per Annex 1 of fixed concentration procedure, the sighting study was conducted at 18 mm/h piston speed and at 10 LPM airflow rate with using dust generator as per OECD 433 traditional protocol using 1 male and female rat to achieve the 1 mg/L chamber air concentration.
Sighting study I exposure conditions:
Aerosol generation system Dust generator
Feeding air supply pressure 200 Kilopascals
Piston speed (mm/h) /Airflow rate (LPM) 18 / 10
Sampling duration 1 minute
Sampling rate (LPM) 4
The animals were exposed in inhalation chamber with dynamic airflow.
The results of sighting study I are given below.
Group No. of animals and sex 1) Test item concentration # in Chamber air, mg/L
2) MMAD (µm) & GSD
3)Nominal Concentration (mg/L) Clinical
signs*
G1 1 M
1 F 1)
Effect levels
- Sex:
- male
- Dose descriptor:
- LC50
- Remarks:
- Based on the results of the present study, the test item “Novoperm-Rot HF3S” is classified as follows: • The test item is classified as category 5 / unclassified as per Annex 1 of the OECD 433 test guideline furnished as Annexure 1 in the report. • The te
- Effect level:
- >= 5.05 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Clinical signs:
- other: All animals were normal after the exposure period
- Body weight:
- All rats gained bodyweight throughout the experiment period
- Gross pathology:
- No abnormality was detected at necropsy in any of the exposed rats
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Based on the results of the present study, the test item is classified as follows: • The test item is classified as category 5 / unclassified as per Annex 1 of the OECD 433 test guideline. • The test item is classified as category 5 as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Ninth Revised Edition, United Nations (2021). ST/SG/AC.10/30/Rev.9, as there was no mortality at 5.05 mg/L of chamber air in male Wistar rats (Appendix 3).
- Conclusions:
- The acute inhalation (4 hours) Median Lethal Concentration (LC50) value of is more than 5.05 mg/L in Wistar rats.
- Executive summary:
An acute inhalation toxicity study with Pigment Red 188 was conducted in Wistar rats with one treatment group (G1).
The inhalation toxicity was determined in 5 male Wistar rats by exposure to test item as a dust aerosol generated by dust generator with an air flow rate of 10 LPM and a piston speed of 92 mm/h with 200 kilopascals of atomizer pressure. The rats were housed in special rat restrainers and continuously exposed to the test item aerosol (nose only) for 4 hours in an inhalation exposure chamber (dynamic state) for the G1 group. The post treatment observation period was 14 days.
The dust aerosol was sampled from the inhalation chamber to determine particle size distribution, Mass Median Aerodynamic Diameter (MMAD) and Geometric standard deviation (GSD). Particle size of the aerosol generated in the chamber air was determined two times i.e., during the first and fourth hour of the exposure period using any one port. The MMAD and GSD was calculated using validated excel spread sheet.
The overall mean MMAD of 2.35 micrometers and GSD of 1.71 was observed for G1 group.
The average actual concentration was 5.05 mg/L of chamber air. The test item concentration at the animals’ breathing zone was determined using gravimetric filter analysis method.
All animals were normal after the exposure period.
All rats gained bodyweight throughout the experiment period. There were no mortalities observed during the experimental period. No abnormality detected at necropsy.
The acute inhalation (4 hours) Median Lethal Concentration (LC50) value of is more than 5.05 mg/L of chamber air in Wistar rats.
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