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Diss Factsheets
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EC number: 935-783-6 | 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study similar to OECD guideline 474 with some deviations: Only one dose level tested, vehicle produced signs of toxicity, only 1000 erythrocytes/animal scored for micronuclei.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- Only one dose level tested, vehicle produced signs of toxicity, only 1000 erythrocytes/animal scored for micronuclei.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Chlorocresol
- EC Number:
- 200-431-6
- EC Name:
- Chlorocresol
- Cas Number:
- 59-50-7
- Molecular formula:
- C7H7ClO
- IUPAC Name:
- 4-chloro-3-methylphenol
- Details on test material:
- - Name of test material (as cited in study report): Preventol CMK
- Physical state: White to colourless crystalline powder
- Analytical purity: 99.96%
- Lot/batch No.: 280
- Storage condition of test material: Approved for use during the study period.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Bor:NMRI (SPF Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 29-44 g bw
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle used: Polyethyleneglycol 400 (PEG 400)
- Concentration of test material in vehicle: Test substance: 25 mg/mL , Pos. control: 2 mg/mL (in deionised water) - Details on exposure:
- The test substance was dissolved in PEG 400 and applied intraperitoneal (i.p.) via injection. The total volume applied was 5 mL/kg bw for the control and treated groups and 10 mL/kg bw for the positive control. Animals were sacrificed depending on their allocation to the different grups 24, 48 and 72 hours after application. The control groups were sacrificed 24 hours after application of PEG 400.
- Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- Not applicable as only one single application was performed.
- Post exposure period:
- treatment group: 24, 48 and 72 hours
control group: 24 hours
positive control: 24 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
125 mg/kg bw
Basis:
other: actual applied intraperitoneal (i.p.)
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- cyclophosphamide (20 mg/kg bw),
Examinations
- Tissues and cell types examined:
- Femoral bone marrow smears were prepared 24, 48 and 72 h after i.p. administration of the test substance according to Schmid´s method (Schmid, W. Mut. Res. 31, 9-15, 1975 and DFG, Kommission für Mutagenitätsfragen, Mitteilungen III, 53-61, 1975). The ratio of polychromatic to normochromatic erythrocytes was determined. In addition all animals were examined for clinical signs of toxicity after administration of the test substance.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Animals of the control and treatment group showed clinical signs of toxicity. Four mice died during the study period.
- Vehicle controls validity:
- other: Animals of the negative control group showed apathy and spasm, lasting for up to 24 hours. Thereafter, their external appearance and physical activity remained unaffected.
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Clinical signs of toxicity:
Animals treated with 125
mg/kg bw test substance showed symptoms of toxicity which comprised
apathy, roughened fur, staggering gait, prone position, spasm, twitching
and diarrhoea. The symptoms lasted until sacrifice.
Animals of the negative control group showed apathy and spasm, lasting
for up to 24 hours. Thereafter, their external appearance and physical
activity remained unaffected. Their feeding behavior was normal.
In the positive control group no symptoms of toxicity were noted.
Mortality:
4 of 40 treated animals died during the test period. The time points of death are listed in the following:
24 hours group: 1 male found dead after 24 hours
48 hours group: 1 female found dead after 48 hours
72 hours group: 1 male found dead after 48 hours
Replacement group: 1 male found dead after 72 hours
Details on Genotoxicity:
The ratio of polychromatic to normochromatic erythrocytes was not altered in the groups which received the test substance (see Table 1). No indications of clastogenic effects of the test substance were found after treatment.
The positive control cyclophosphamide caused a clear clastogenic effect which is shown by the significant increase of polychromatic erythrocytes with micronuclei. The ratio of polychromatic to normochromatic erythrocytes was not altered (see Table 1).
Table 1: Results of the Micronucleus test in mice
Experimental group |
Time of sacrifice |
Number of evaluated polychromatic erythrocytes per animal |
No. of normochromatic erythrocytes per 1000 polychromatic erythrocytes |
Micronucleated cells per 1000 |
|
normochromatic erythrocytes |
polychromatic erythrocytes |
||||
Negative controla |
24 |
1000 |
1179 ± 495 |
1.3 ± 1.1 |
1.2 ± 0.9 |
Test substanceb |
24 |
1000 |
1319 ± 439 |
0.7 ± 0.9 |
1.3 ± 1.4 |
Test substanceb |
48 |
1000 |
1595 ± 633 |
1.2 ± 0.9 |
0.7 ± 0.8 |
Test substanceb |
72 |
1000 |
1524 ± 1185 |
0.7 ± 0.7 |
1.1 ± 0.7 |
Positive controlc |
24 |
1000 |
881 ± 160 |
1.3 ± 1.2 |
16.1* ± 6.4 |
aPolyethyleneglycol 400 (as intraperitoneal injection) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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