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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 vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- 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: see 'Remark'
- Remarks:
- GLP compliant study which followed OECD Guideline 482 without deviations, tested with the source substance CAS 59-50-7. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 482 (Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro
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 crystals
- Analytical purity: 99.9%
- Lot/batch No.: 792/1987
- Stability under test conditions: Not reported
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- hepatocytes: Rat primary hepatocytes from an adult male F344 rat (150-300 g bw). A single animal was used for each trial.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with
- Metabolic activation system:
- intrinsic
- Test concentrations with justification for top dose:
- Trial 02: 0.25, 0.5, 2.5, 7.5, 10, 20 µg/mL
Trial 03: 2.53, 5.06, 7.58, 10.1, 15.2, 20.2, 30.3 µg/mL
Trial 01 was discarded due to excessive cytotoxicity. - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle: The test substance was not soluble in medium and was dissolved in DMSO at a concentration of 502 mg/mL forming a clear, colourless solution. With DMSO as vehicle, the test substance was soluble in the medium at concentrations up to 2010 µg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- Migrated to IUCLID6: 0.1µg/mL (vehicle DMSO)
- Details on test system and experimental conditions:
- Freshly prepared rat hepatocytes were exposed to 6 (trial 02) and 7 (trial 03) concentrations of test substance ranging from 0.25 µg/mL to 30.3 µg/mL in the presence of 5 µCi/mL ³H-thymidine for 18-19 hours in medium with reduced serum content (1% FCS).
The cells were fixed, washed and air-dried prior to coating in the dark with photographic emulsion. The coated slides were stored at 4°C for 4-10 days and then developed. The slides were then rinsed and stained with haematoxylin/eosin.
Grain counting was done manually using a microscope with 1500x magnification and oil immersion. Each slide was examined for 3H-incorporation (silver grain formation) by counting 50 cells per slide, normally with 3 slides per dose group. The cytotoxicity was assessed using (trypan blue exclusion). Trial 01 was discarded due to excessive cytotoxicity. - Evaluation criteria:
- The assay was deemed acceptable if the following criteria were met:
1. The viability of the hepatocytes must exceed 50%.
2. The viability of the monolayer cell cultures used for the UDS assay must be 70% or greater.
3. The number of viable cells in the vehicle control cultures should remain reasonably stable throughout the experiment; the number of viable cells in the vehicle control cultures must be ≥ 50% at the beginning of the treatment period.
4. For each of the 50 cells on each slide, the number of nuclear grains is scored, as well as numbers of three cytoplasmic grain counts from nuclear-sized areas adjacent to each nucleus.
5. The average net nuclear grain counts (NG) in the negative control cultures should range between -5 to +1. No more than 10% of the cells should contain ≥ 6 grains, or 1% of the cells ≥ 20 grains.
6. For the positive control 2-AAF (0.1 µg/mL), one might expect mean values of 13 NG with 83% and 21% of the nuclei having more than 6 and 20 grains, respectively.
7. For the conditions described, if a chemical yields ≥ 6 NG in the population average or ≥ 6 NG in ≥ 10% of the cells or ≥ 20 NG in ≥ 2% of the cells, the response is considered positive.
8. Grain count data obtained for a given treatment are acceptable as part of the evaluation if obtained from at least two replicate cultures and at least fifty cells per culture.
9. A minimum of 6 dose levels will be analysed for NG. Repeat trials need only augment the number of analysed dose levels in the first trial to achieve a total of 6 different dose levels.
10. The highest analysed dose must give rise to cytotoxicity or result in insolubility of the test material or reach a maximum concentration of 5 mg/mL.
Results and discussion
Test results
- Species / strain:
- hepatocytes: Rat primary hepatocytes from an adult male F344 rat (150-300 g bw). A single animal was used for each trial.
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The survival rate of hepatocytes was 43% at 20 µg/mL in trial 02.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results of trial 2 of the UDS assay in primary rat hepatocytes*
Concentration [µg/mL] |
Net grainsa per nucleus |
Avg % nuclei with ≥ 6 grains |
Avg % nuclei with ≥ 20 grains |
Survivaldat 21.5 h |
|
Vehicle control |
-2.63 |
0.7 |
0.0 |
100.0 |
|
0.250 |
-2.69 |
3.3 |
0.0 |
n.d. |
|
0.500 |
-2.05 |
2.7 |
0.0 |
100.3 |
|
2.50 |
-1.40 |
2.0 |
0.0 |
95.2 |
|
7.50 |
-1.32 |
1.4b |
0.0b |
77.9
|
|
10.0 |
-1.83 |
0.7 |
0.0 |
67.0
|
|
20.0 |
-1.62b |
0.7b |
0.0b |
42.8
|
|
Pos. control |
21.77b |
98.6b |
57.3b |
99.8 |
|
*1stassay was discarded due to excessive cytotoxicity
|
Table 2: Results of trial 3 of the UDS assay in primary rat hepatocytes
Concentration [µg/mL] |
Net grainsa per nucleus |
Avg % nuclei with ≥ 6 grains |
Avg % nuclei with ≥ 20 grains |
Survivaldat 20 h |
|
Vehicle control |
-0.03 |
6.0 |
0.0 |
100.0 |
|
2.53 |
-0.43 |
3.3 |
0.0 |
100.6 |
|
5.06 |
-0.31 |
0.7 |
0.0 |
98.8 |
|
7.58 |
-0.62 |
0.7 |
0.0 |
98.2 |
|
10.1 |
-0.21 |
2.0 |
0.0 |
99.1
|
|
15.2 |
-0.62b |
0.0b |
0.0b |
98.7
|
|
20.2 |
0.14 |
0.7 |
0.0 |
87.7
|
|
30.3 |
n.d. |
n.d. |
n.d. |
53.0
|
|
Pos. control |
21.69 |
99.3 |
52.0 |
99.4 |
|
aAverage of net nuclear grain counts on triplicate coverslips (150 total cells)
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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