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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-424-3 | CAS number: 95-49-8
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-11-22 to 2001-03-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Remarks:
- High Performance Liquid Chromatography (HPLC)
- Details on sampling:
- For each test vessel in all test groups, 0.75 mL of each test solution before and after water change was taken three times during the exposure period, equal amounts of acetonitrile were added, mixed, and then analyzed by HPLC. The test substance of each test solution was quantified from the ratio with the peak area of the standard solution.
- Vehicle:
- yes
- Remarks:
- 2-methoxyethanol and HCO-60
- Details on test solutions:
- The diluted water at the time of preparing the test solution was set to 24 ± 1 °C in a constant temperature bath before preparation. To 462 μL of the test substance (500 mg in terms of specific gravity), 500 mg of 2-methoxyethanol and 1500 mg of the dispersion aid (HCO-40) were added, mixed and dissolved, and then the volume was adjusted to 500 mL with purified water to prepare the test substance stock solution. The test substance stock solution has a concentration of 1000 mg/L.
As for the control solution of the solvent agent, 500 mg of 2-methoxyethanol and 1500 mg of the dispersion solvent agent (HCO-40) were added to 500 mL of purified water.
The test substance stock solution and the solvent agent stock solution were collected, and the volume was adjusted to 5.0 L with diluted water. amounts are listed in Table 1 (see. additional information) .
The test solution at the time of preparation was colorless and transparent in all test groups. - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- 1) Japanese name: Himedaka
2) Scientific name: Oryzias latipes
3) Obtained from: Sankyo Fisheries Co., Ltd. (1-1, Ichigayatamachi, Shinjuku-ku, Tokyo)
4) Date of aquisition: February 5, 2001
5) Lot number: 01-H-0205
6) Body length: 2.21 cm (1.97 to 2.45 cm), n = 10
7) Weight: 0.148 (0.103 to 0.244 g), n = 10
8) Sensitivity: 96 hours median lethal concentration (LC50) = 0.86 mg/L
(this value is the LC50 value 0.44 - 1.5 mg/L since 1995) with the reference substance (copper sulfate (H)
pentahydrate, reagent technical grade), n = 14)
9) Acclimatisation period: From February 9, 2001 to February 26, 2001, the mortality rate was less than 5% for 7 days before the start
of exposure, and macroscopically healthy and normal individuals were used in the study.
10) Holding conditions:
- Holding water: diluted water (see 3.2)
- Holding condition: Water type (breeding density: 1.0 g/L/day or less)
- Water temperature: 24 ± 1 ° C
- Dissolved oxygen concentration: 80% or more of saturation concentration
- pH: 6.5 to 8. 5
- Lighting: Room light, 16 hours light (1000 lux or less)/8 hours dark
- Food type: Tetrabike Tetramine
- Feeding amount: Approximately 2% of fish body weight/day (no feeding from 24 hour before the start of exposure) - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- No data
- Test temperature:
- 23.3 - 23.4 °C
- pH:
- 6.9 - 7.5
- Dissolved oxygen:
- 5.5 - 8.4 mg/L
- Salinity:
- n.a.
- Conductivity:
- No data
- Nominal and measured concentrations:
- Test concentration (n): 0.25, 4.40, 7.90, 14.0, 25.0 mg/L (common ratio: about 1.8)
- Details on test conditions:
- I. Test conditions
1) Exposure method : Semi-static (the entire amount of test solution was replaced after 24 hours),
cover the water surface with Teflon sheet
2) Exposure period : 96 hours
3) Test water volume : 5.0 L/test aquarium
4) Number of test vessels : 1 aquarium/test design
5) Number of test organisms : 10 fish/test design
6) Test water temperature : 24+1 °C
7) Dissolved oxygen concentration : 60% or more of saturation concentration
8) pH : No adjustment of pH of test solution
9) Illumination : 16 hours bright (1000 lux or less)/8 hours dark
10) Feeding : No feeding
II. Diluted water
Dechlorinated water (Yokohama city tap water treated with activated carbon to remove residual chlorine, etc., and well ventilated) was used.
III. Test concentration design
Based on the results of the preliminary test (1 test vessel each, 5 fish/test concentration) shown in the table below, the test concentration of the main test was determined as follows.
Test concentration: control group, solvent control group: 0.25, 4.40, 7.90, 14.0, 25.0 mg/L (common ratio: about 1.8)
IV Observation (Toxicological symptoms):
- Death : A case in which no reaction is observed when a stimulus is given.
- Abnormal respiration : The movement of the gill lid is different from that of the fish in the control group.
- Abnormal swimming : Swimming that is clearly different from the fish in the control area. Slow movement,
irritability, convulsions, inversion, etc.
- Inability to swim : Those who are moving at the bottom or on the surface of the water but are unable to swim in the water.
Includes rollover and asphyxia.
V. Water temperature, dissolved oxygen concentration and pH of the test solution:
The pH, dissolved oxygen concentration and water temperature were measured once daily during the exposure period. - Reference substance (positive control):
- yes
- Remarks:
- copper sulfate (H) pentahydrate, reagent technical grade
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 7.67 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- (95%-confidence limit: 5.66 mg/L to 10.4 mg/L)
- Results with reference substance (positive control):
- 96 hours median lethal concentration (LC50) = 0.86 mg/L
- Sublethal observations / clinical signs:
Table 2: Measured concentrations of substance in test water
Nominal concentration
Measured concentration [mg/L]
(Percent of nominal)Mean* measured concentration
[mg/L]0 hour (new) 24 hours (old) Control (Blank) < 0.003 < 0.003 --- Solvent Control < 0.003 < 0.003 --- 2.50 2.40
(96)2.14
(86)2.27
(91)4.40 4.11
(93)3.76
(85)3.93
(89)7.90 7.13
(90)6.33
(80)6.72
(85)14.0 13.0
(93)12.0
(86)12.5
(89)25.0 23.2
(93)--
(--)23.2
(93)* geometric mean
new: freshly prepared test solutions
old: test solutions after 24hours exposure
--: No measurement was made because all Medaka were dead at this observation time.Table 3: Mortality of the Medaka (Oryzas latipes) exposed to the test substance
Nominal concentration [mg/L] Mean* measured concentration [mg/L] cumulative mortality (Percent mortality) 24 hours 48 hours 72 hours 96 hours Control ---- 1 (10) 1 (10) 1 (10) 1 (10) Solvent Control ---- 0 (0) 0 (0) 0 (0) 0 (0) 2.50 2.27 0 (0) 1 (10) 1 (10) 1 (10) 4.40 3.93 0 (0) 0 (0) 1 (10) 1 (10) 7.90 6.72 0 (0) 0 (0) 2 (20) 4 (40) 14.0 12.5 8 (80) 8 (80) 8 (80) 9 (90) 25.00 23.2 10 (100) 10 (100) 10 (100) 10 (100) * geometric mean
- Validity criteria fulfilled:
- yes
- Conclusions:
- The mortality to fish was investigated under semi-static static conditions in a GLP study following OECD 203. After 96 hours exposure, the median lethal concentration (LC50) based on nominal concentration was 7.7 mg/L.
- Executive summary:
This test is based on the OECD Guidelines for Testing of Chemicals No. It was conducted in accordance with 203 “Fish Toxicity Test" (1992). For o-chlorotoluene, an acute toxicity test against medaka (Oryzias latipes) was performed to determine the median lethal concentration (LC50) for 96 hours under semi-static exposure conditions. At the start of exposure, the weight and scale length of 10 fish acclimatized in the same tank as the test fish were measured. No feeding was done during the dew. After measuring the pH, dissolved oxygen concentration, and water temperature of the test solution in each test container, 10 fish under test were placed in the test container per concentration group. The pH, dissolved oxygen concentration and water temperature were measured once daily during the exposure period. Deaths were recorded 24, 48, 72 and 96 hours after the start of exposure and any signs or abnormalities of toxicity observed were recorded. Other specific cases (bending of the back, bleeding, change in body color, secretion of mucus, etc.) are described separately when observed. When dead individuals were found, they were promptly removed to prevent deterioration of water quality. Based on the results of the preliminary test the test concentration of the main test were determined (0.25, 4.40, 7.90, 14.0, 25.0 mg/L (common ratio: about 1.8)) Recovery rates for the substance were > 80 % of the nominal concentration in all sampling points.. After 96 hours exposure, the median lethal concentration (LC50) based on nominal concentration was 7.7 mg/L. In addition, as a result of an acute toxicity test using a reference substance (copper sulfate (H) pentahydrate, reagent special grade) of the test fish, the LC50 for 96 hours was 0.86 mg/L. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute fish toxicity study.
Reference
Description of key information
The acute toxicity of 2-chlorotoluene towards fish was tested following the OECD Guideline 203, yielding a LC50 (96h; Oryzias latipes; analytically confirmed) of 7.7 mg/L (MOE Japan, 2001).
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- 7.67 mg/L
Additional information
The valid and reliable key study (MOE Japan, 2001) was performed compliant with GLP according to OECD TG 203 (1992). 2-chlorotoluene toxicity towards Japanese Medaka (Oryzias latipes) was assessed for 96 hours under semi-static exposure conditions. 10 fish were placed in the test container per concentration group. The pH, dissolved oxygen concentration and water temperature were measured once daily during the exposure period and validity criteria of the testing guideline were met. Deaths were recorded 24, 48, 72 and 96 hours after the start of exposure and any signs or abnormalities of toxicity observed were recorded. Analytical monitoring of test item concentrations in fresh and aged (24 h) medium confirmed the nominal concentration (within +/- 20%). Accordingly, evaluation of results was performed based on nominal concentrations.
Results of the study:
LC50 (Oryzias latipes; 96 h; analytically confirmed) = 7.67 mg/L (95% CI: 5.66 - 10.4).
The reliable and relevant result of the key study is confirmed by not assignable (RL 4) data on acute aquatic toxicity towards Pimephales promelas and Oncorhynchus mykiss, which obviously were determined in a flow-through system with analytically confirmed exposure concentrations (Federal Register USA, 1982) with the following results:
LC50 (Pimephales promelas; 96 h) = 7.5 (95% CI: 6.1-9.8);
LC50 (Oncorhynchus mykiss; 96 h) = 2.3 mg/L (95% CI: 1.8-3.0).
These results are very close to and of the same order of magnitude as the result of the key study. While not assignable, these data corroborate the result of the key study.
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.