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Diss Factsheets
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EC number: 203-402-6 | CAS number: 106-48-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Principles of method if other than guideline:
- Remark: All schedules and examinations were performed in compliance with the Test Guideline ‘‘28 day repeated-dose toxicity study using mammals’’ of the Japanese Chemical Control Act (Official Name: Law Concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances). This guideline is equivalent to OECD Test Guideline 407.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-chlorophenol
- EC Number:
- 203-402-6
- EC Name:
- 4-chlorophenol
- Cas Number:
- 106-48-9
- Molecular formula:
- C6H5ClO
- IUPAC Name:
- 4-chlorophenol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SPF [Crj:CD(SD)IGS]
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan Inc. (Kanagawa, Japan)
- Age at study initiation: 5–6 week
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2°
- Humidity (%): 55 ± 15
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test solutions were prepared at least once a week and were kept cool and in the dark until dosing. The stability was confirmed to be at least seven days under these conditions.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
20 mg/kg bw/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
100 mg/kg bw/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
500 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 animals
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Dose-finding study
- Rationale for selecting satellite groups: To measure pro-longing effects
- Post-exposure recovery period in satellite groups: Two weeks (sacrificed at 11 or 12 weeks of age)
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- General behavior
DETAILED CLINICAL OBSERVATIONS: Yes
- Tremors
- Hypoactivity
- Abnormal gait
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes (Blood biochemistry)
URINALYSIS: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- necropsy findings
- organ weights
HISTOPATHOLOGY: Yes
- Kidney
- Liver - Statistics:
- - Quantitative data: Bartlett’s test (Bartlett 1937); homogeneity of distribution
- Recognized homogeneity: Dunnett’s test (Dunnett 1964); comparison between control and individual treatment groups.
- Not homogenous data: Steel’s multiple comparison test (Steel 1959) or the mean rank test of the Dunnett type (Hollander & Wolfe 1973).
- Qualitative data, e.g. histopathological findings: Mann–Whitney’s U-test (Mann & Whitney 1947) or Fisher’s exact test (Fisher 1973)
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS:
- Tremors, tachypnea and salivation were observed from five to 30 minutes after dosing in most animals in both sexes at 500 mg/kg bw/d.
- There were no other dose-dependent changes at any dose.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Tremors, tachypnea and salivation.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Toxicity findings for the test substance in young rat main study |
|||
Males |
Dose [mg/kg bw/d] |
||
|
0 |
100 |
500 |
General behaviour |
|
||
Tremors |
0/12 |
0/6 |
12/12 |
Tachypnea |
0/12 |
0/6 |
11/12 |
Salivation |
0/12 |
0/6 |
9/12 |
Histopathology |
|
||
Kidney |
0/6 |
0/6 |
0/6 |
Liver |
0/6 |
0/6 |
0/6 |
Data are numbers of animals with the change of the total examined. |
Toxicity findings for the test substance in young rat main study |
|||
Females |
Dose [mg/kg bw/d] |
||
|
0 |
100 |
500 |
General behaviour |
|
||
Tremors |
0/12 |
0/6 |
11/12 |
Tachypnea |
0/12 |
0/6 |
9/12 |
Salivation |
0/12 |
0/6 |
8/12 |
Histopathology |
|
||
Kidney |
0/6 |
0/6 |
0/6 |
Liver |
0/6 |
0/6 |
0/6 |
Data are numbers of animals with the change of the total examined. |
Applicant's summary and conclusion
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.