Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 240-474-8 | CAS number: 16423-68-0
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
- Objective of study:
- excretion
- metabolism
- Qualifier:
- according to guideline
- Guideline:
- other: Excretion and Metabolism study of the test chemical
- Principles of method if other than guideline:
- The present investigation deals with the metabolism and excretion of the test chemical
- GLP compliance:
- not specified
- Radiolabelling:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: Young Adult
- Weight at study initiation: 200 g
- Housing: After dosing, the animals were placed in individual metabolism cages and urine collected free from feces in a glass separator (Gage, 1961)
- Diet (e.g. ad libitum): The animals were maintained on Diet 86 (North-Eastern Agricultural Cooperative).
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To: - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: 0.5 g/kg of the test chemical was administered in aqueous suspension to rats
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food: - Duration and frequency of treatment / exposure:
- 3 days
- Remarks:
- 64, 108, 156, 100 mg
- No. of animals per sex per dose / concentration:
- 64, 108, 156 - number of animals - 4
100 - number of animals - 2 - Control animals:
- not specified
- Positive control reference chemical:
- Details not available
- Details on study design:
- no data available
- Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): urine, faeces, blood, plasma, serum or other tissues, cage washes, bile ): urine
- Time and frequency of sampling:
- Other: To minimize oxidation of am!nophenols, the urine collectors were immersed in solid carbon dioxide. Urine was analyzed daily for at least 3 days after dosing
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled (delete / add / specify): urine, faeces, tissues, cage washes, bile ) urine
- Time and frequency of sampling: Urine was analyzed daily for at least 3 days after dosing
- From how many animals: (samples pooled or not) : 4
- Method type(s) for identification (e.g. GC-FID, GC-MS, HPLC-DAD, HPLC-MS-MS, HPLC-UV, Liquid scintillation counting, NMR, TLC) : Glucuronic acid and ethereal sulfate were determined
as described by Mead et al., 1958. Ultraviolet absorption measurements were made on a Unicam SPSOO spectrophotometer in silica cells with a 10-mm optical path. Measurements in the visible range were made on a Unicam SP600 spectrophotometer. Infrared spectra were determined in Nujol mull on a Grub-Parsons G62 spectrophotometer.
- Limits of detection and quantification:
- Other: Isolation and identification of metabolites was estimated fluorimetrically in bile using an Aminco-Bowman spectrophotofluorimeter. Various dilutions of bile were made in 0.1 M Na2HP04 (pH 9.1) and the test chemical was estimated at 550 rnp after activation at 528 mu. The instrument was set at zero absorbance against a solution of the test chemical (1 ug/ml) in 0.1 M Na2HP04.
TREATMENT FOR CLEAVAGE OF CONJUGATES (if applicable): - Statistics:
- Details not available
- Type:
- metabolism
- Results:
- It appeared that the test chemical was metabolized to some extent in the tissues
- Type:
- excretion
- Results:
- The test chemcial was found to be largely excreted in the feces and no color could be identified in the urine. A small amount of the color is excreted in the bile, and, on the basis of the amount of color recovered (50-70%).
- Details on absorption:
- Details not available
- Details on distribution in tissues:
- Details not available
- Details on excretion:
- The test chemcial was found to be largely excreted in the feces and no color could be identified in the urine. A small amount of the color is excreted in the bile, and, on the basis of the amount of color recovered (50-70%).
- Metabolites identified:
- not specified
- Details on metabolites:
- Details not available
- Conclusions:
- The test chemical was found to be largely excreted in the feces and, despite the presence of two groups capable of undergoing conjugation, no color could be identified in the urine. A small amount of the color is excreted in the bile, and, on the basis of the amount of color recovered (50-70% ),it appeared that the test chemical was metabolized to some extent in the tissues.
- Executive summary:
A study has been performed to assess the metabolic behavior of the test chemical. 0.5 g/kg of the test chemical was administered in aqueous suspension to rats. The animals were maintained on Diet 86 (North-Eastern Agricultural Cooperative). After dosing, the animals were placed in individual metabolism cages and urine collected free from feces in a glass separator (Gage, 1961). To minimize oxidation of aminophenols, the urine collectors were immersed in solid carbon dioxide. Urine was analyzed daily for at least 3 days after dosing. All animals used were males. Glucuronic acid and ethereal sulfate were determined as described by Mead et al., 1958. Ultraviolet absorption measurements were made on a Unicam SP500 spectrophotometer in silica cells with a 10-mm optical path. Measurements in the visible range were made on a Unicam SP600 spectrophotometer. Infrared spectra were determined in Nujol mull on a Grub-Parsons G62 spectrophotometer. Isolation and identification of metabolites was estimated fluorimetrically in bile using an Aminco-Bowman spectrophotofluorimeter. Various dilutions of bile were made in 0.1 M Na2HP04(pH 9.1) and the test chemical was estimated at 550 mµ after activation at 528 mµ. The instrument was set at zero absorbance against a solution of the test chemical (1 µg/ml) in 0.1 M Na2HP04.The test chemical was found to be largely excreted in the feces and, despite the presence of two groups capable of undergoing conjugation, no color could be identified in the urine. A small amount of the color is excreted in the bile, and, on the basis of the amount of color recovered (50-70% ),it appeared that the test chemical was metabolized to some extent in the tissues
Reference
THE EXCRETION, IN RATS, OF THE TEST CHEMICAL IN THE BILE AND FECES
Total amount fed (mg) |
Number of animals |
Excreted in feces (%) |
Excreted in bile (%) |
64 |
4 |
60 |
- |
108 |
4 |
72 |
- |
156 |
4 |
55 |
- |
100 |
1 |
- |
0.44 |
100 |
1 |
- |
1.67 |
Description of key information
A study has been performed to assess the metabolic behavior of the test chemical. 0.5 g/kg of the test chemical was administered in aqueous suspension to rats. The animals were maintained on Diet 86 (North-Eastern Agricultural Cooperative). After dosing, the animals were placed in individual metabolism cages and urine collected free from feces in a glass separator (Gage, 1961). To minimize oxidation of aminophenols, the urine collectors were immersed in solid carbon dioxide. Urine was analyzed daily for at least 3 days after dosing. All animals used were males. Glucuronic acid and ethereal sulfate were determined as described by Mead et al., 1958. Ultraviolet absorption measurements were made on a Unicam SP500 spectrophotometer in silica cells with a 10-mm optical path. Measurements in the visible range were made on a Unicam SP600 spectrophotometer. Infrared spectra were determined in Nujol mull on a Grub-Parsons G62 spectrophotometer. Isolation and identification of metabolites was estimated fluorimetrically in bile using an Aminco-Bowman spectrophotofluorimeter. Various dilutions of bile were made in 0.1 M Na2HP04(pH 9.1) and the test chemical was estimated at 550 mµ after activation at 528 mµ. The instrument was set at zero absorbance against a solution of the test chemical (1 µg/ml) in 0.1 M Na2HP04.The test chemical was found to be largely excreted in the feces and, despite the presence of two groups capable of undergoing conjugation, no color could be identified in the urine. A small amount of the color is excreted in the bile, and, on the basis of the amount of color recovered (50-70% ),it appeared that the test chemical was metabolized to some extent in the tissues
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 1
Additional information
Various studies have been reviewed to assess the metabolic behavior of the test chemical. The results are mentioned below:
A study has been performed to assess the metabolic behavior of the test chemical. 0.5 g/kg of the test chemical was administered in aqueous suspension to rats. The animals were maintained on Diet 86 (North-Eastern Agricultural Cooperative). After dosing, the animals were placed in individual metabolism cages and urine collected free from feces in a glass separator (Gage, 1961). To minimize oxidation of aminophenols, the urine collectors were immersed in solid carbon dioxide. Urine was analyzed daily for at least 3 days after dosing. All animals used were males. Glucuronic acid and ethereal sulfate were determined as described by Mead et al., 1958. Ultraviolet absorption measurements were made on a Unicam SP500 spectrophotometer in silica cells with a 10-mm optical path. Measurements in the visible range were made on a Unicam SP600 spectrophotometer. Infrared spectra were determined in Nujol mull on a Grub-Parsons G62 spectrophotometer. Isolation and identification of metabolites was estimated fluorimetrically in bile using an Aminco-Bowman spectrophotofluorimeter. Various dilutions of bile were made in 0.1 M Na2HP04(pH 9.1) and the test chemical was estimated at 550 mµ after activation at 528 mµ. The instrument was set at zero absorbance against a solution of the test chemical (1 µg/ml) in 0.1 M Na2HP04.The test chemical was found to be largely excreted in the feces and, despite the presence of two groups capable of undergoing conjugation, no color could be identified in the urine. A small amount of the color is excreted in the bile, and, on the basis of the amount of color recovered (50-70% ),it appeared that the test chemical was metabolized to some extent in the tissues.
This result is supported by another study performed to assess the metabolism and excretion patterns of the test chemical in rats.Metabolism and excretion of the test chemical was investigated after single oral administration of different amounts of the substance. In dye metabolism studies, urine specimens were collected within a 2-4 hr period after oral (gavage) administration of four different doses of the test chemical; bile specimens were taken 2 hr after administration. In dye excretion studies, bile-duct cannulated rats received 3 mg/kg bw via the femoral vein, urine and bile was collected over a 2 hr period. For dye recovery studies, animals received 500 mg/kg bw by gavage and excreta were collected until dye excretion was no longer detectable. Samples were examined by paper chromatography (with and without enzymatic cleavage). Chromatographic analysis of excreta revealed, that the dyes were metabolically stable and that glucuronidation did not take place. The presence of dye in either bile or urine within 2-4 hours after oral administration pointed to systemic absorption (no quantitative data given). After i.v. administration, the major part (average: 55 %; range: 50.4 – 58.0 %) of the administered dose was recovered in bile, whereas on the average, 1.3 % (range: 0.8 – 1.8 %) of the dose could be determined in the urine within 2 hours after administration. and urine within a period of 2 hrs. The dye recovery part of the study revealed, that 101.9 % of the applied dose could be recovered from excreta within 5 days after oral administration.
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.