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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-251-9 | CAS number: 118-45-6
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-chlorophthalic anhydride
- EC Number:
- 204-251-9
- EC Name:
- 4-chlorophthalic anhydride
- Cas Number:
- 118-45-6
- Molecular formula:
- C8-H3-Cl-O3
- IUPAC Name:
- 5-chloro-1,3-dihydro-2-benzofuran-1,3-dione
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Start (from stock solutions prior to distribution to test chambers) and end of the test (from pooled test replicates)
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Water used for acclimation of test organisms and for all toxicity testing was sterile freshwater AAP medium adjusted to pH of 7.5 +/- 0.1. Dilution water collected at the start of the definitive toxicity test had a measured total organic carbon concentration of 4.6 ppm. A stock solution with a nominal concentration of 1,000 mg/L was prepared by bringing 1.0661 g of test substance to a total volume of 1,000 mL with dilution water in a glass volumetric flask. The solution was mixed for approximately 27 hours. The pH of the stock solution was adjusted to 7.5 using 1 N sodium hydroxide. The test concentrations were formulated by the addition of appropriate amounts of the stock solution directly to dilution water. Nominal concentrations of 4 CLPA were 0 mg/L (control), 65, 130, 250, 500, and 1,000 mg/L. A stability blank sample set up at 1,000 mg/L was placed among the test vessels.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Algae used for the test (Selenastrum capricornutum, UTEX 1648) were from a culture originally procured from the Culture Collection of Algae at the University of Texas at Austin and delivered to T.R. Wilbury Laboratories on July 17, 2001. The culture was transferred to sterile enriched media identical to media used for this test and maintained at test conditions for at least 14 days before the definitive test. During the 14 day acclimation period prior to the start of the test, the temperature ranged from 23.8 to 24.0°C and the light intensity ranged from 50 to 51 microEin/m^2sec (24 hours light/0 hours dark photoperiod). During the acclimation period, the culture was actively growing in at least two subcultures prior to the start of the toxicity test. The subsample of algae used to inoculate media at the start of the definitive test came from a four day old culture. Identification of the culture organisms, which are also referred to as Raphidocelis subcapitata, was verified using an appropriate taxonomic key.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- None
Test conditions
- Test temperature:
- 24.0 - 24.5°C
- pH:
- 7.4 - 7.5 initial; 7.8 - 9.5 final
- Nominal and measured concentrations:
- Nominal: 0 mg/L (control) 65, 130, 250, 500, and 1,000 mg 4-CLPA/L
Mean measured: ND (not detected at or above the LOQ; control), 59.7, 124, 239, 478 and 933 mg 4 CLPA/L - Details on test conditions:
- A range-finding test was conducted with a control, solvent control (0.1 ml/L dimethylformamide), and four concentrations of 4 CLPA: 0.10, 1.0, 10, and 20 mg/L. At the conclusion of the test, the number of cells/mL in the test vessels qualled the following percent of the number of cells/mL in the control vessels: solvent control = 100%, 0.10 mg/L = 98%, 1.0 mg/L = 106%, 10 mg/L = 82%, and 20 mg/L = 103%. Fine white particles were observed on the media surface in test vessels with a nominal concentration of 20 mg/L at the start of the test. No other insoluble material was observed during the range-finding test.
A second range-finding test was conducted with a control and two concentrations of 4 CLPA: 100 and 1,000 mg/L. A stock solution with a nominal concentration of 1,000 mg/L was prepared without the use of a solvent and allowed to mix for approximately 24 hours. The pH of the stock solution was adjusted to 7.5 using 0.1N sodium hydroxide. At the conclusion of the test, the number of cells/mL in the test vessels equaled the following percent of the number of cells/mL in the control vessels: 100 mg/L = 106% and 1,000 mg/L = 104%. No insoluble material was observed during the range-finding test.
The definitive toxicity test was conducted at 24 +/- 2°C with five concentrations of test substance and a control. Nominal concentrations of 4-CLPA were 0 mg/L (control), 65, 130, 250, 500, and 1,000 mg/L. A stability blank sample set up at 1,000 mg/L was placed among the test vessels. No algae was inoculated into the stability blank. Water quality measurements were made and each solution was subdivided into three clear glass 250 mL Erlenmeyer flasks. Flasks were inoculated with approximately 10,000 algal cells/mL and capped with inverted glass beakers. Test vessels were randomly arranged on a rotary shaker adjusted to approximately 100 rpm in an incubator during the test (a random numbers table was used to select the location for each vessel) and vessels were repositioned daily. A 24 hour light and 0 hour dark photoperiod was automatically maintained with cool white fluorescent lights that provided a light intensity of approximately 400 footcandles (also measured as approximately 52 to 55 microEin/m^2sec). The number of algal cells/mL in each test vessel and the occurrence of relative size differences, unusual cell shapes, colors, flocculations, adherence of cells to test containers, or aggregation of cells was determined visually by means of direct microscopic examination with a hemocytometer at 24, 48, and 72 hours. Temperature of the incubator was measured and recorded daily and the temperature in a representative vessel of water incubated with the test vessels was continuously recorded. The pH of test solutions was measured and recorded in each test solution prior to distribution to the test vessels at the start of the test and in each test vessel at the end of the test. - Reference substance (positive control):
- not required
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 933 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Number of cells/mL
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 478 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Number of cells/mL
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 933 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Number of cells/mL
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 933 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Number of cells/mL
- Details on results:
- Insoluble material was not observed at any time during the definitive toxicity test. Nominal concentrations of 4-CLPA were: 0 mg/L (control), 65, 130, 250, 500, and 1,000 mg/L. Mean measured concentrations were ND (none detected; control), 59.7, 124, 239, 478, and 933 mg/L. These mean measured concentrations were 92 to 96% of nominal concentrations. The mean measured concentration in the stability blank (a 1,000 mg/L 4 CLPAsolution without algae that was incubated under test conditions for 72 hours) was 95% of the nominal concentration.
The algal population grew well, resulting in an average of 1,230,000 cells/mL in the control after 72 hours. No effects (relative size differences, unusual cell shapes, colors, flocculations, adherence of cells to test containers, or aggregation of cells) were noted during the test. Water quality throughout the test was within acceptable limits. The incubator temperature ranged from 24.0 to 24.5°C - Reported statistics and error estimates:
- The average specific growth rate was calculated as the natural log of the number of cells/mL at time t1 minus the natural log of the number of cells/mL at time t0 divided by the exposure period. The 24, 48, and 72 hour EC50 values could not be calculated using standard statistical procedures because cell growth and growth rates at all tested concentrations were greater than 50% of the control. The no observed effect concentration (NOEC) was determined using a one-way analysis of variance (ANOVA) and William’s test. The NOECs were determined using the mean measured concentrations of 4-CLPA and the number of cells/mL and average specific growth rate. Treatment data were compared to control data for the determination of the NOEC values.
Any other information on results incl. tables
Measured concentrations of 4-CLPA during the toxicity test with the freshwater alga, Selenastrum capricornutum
Nominal Concentration of 4-CLPA (mg/L) |
Measured Concentration of 4-CLPA (mg/L) |
|||
0 Hour |
72 Hour |
Mean |
% Recovery |
|
Test Media Samples |
||||
Control |
ND |
--- |
ND |
--- |
65 |
59.3 |
60 |
59.7 |
92 |
130 |
123 |
124 |
124 |
95 |
250 |
234 |
244 |
239 |
96 |
500 |
461 |
495 |
478 |
96 |
1,000 |
907 |
959 |
933 |
93 |
Stability Blank |
||||
1,000 |
925 |
982 |
954 |
95 |
Laboratory Control Sample |
||||
250 |
196 |
228 |
212 |
85 |
Blank |
||||
0 |
ND |
--- |
ND |
--- |
ND = none detected at or above the limit of quantitation of 0.0251 mg/L. |
Cell growth data from the toxicity test with 4-CLPA and the freshwater alga, Selenastrum capricornutum
Measured Concentration of 4-CLPA (mg/L) |
Replicate |
Number of Cells per Milliliter |
|||
Hour of Exposure |
|||||
0 |
24 |
48 |
72 |
||
Control |
1 |
10,000 |
58,000 |
132,000 |
1,180,000 |
2 |
10,000 |
52,000 |
180,000 |
1,270,000 |
|
3 |
10,000 |
50,000 |
186,000 |
1,240,000 |
|
mean |
10,000 |
53,000 |
166,000 |
1,230,000 |
|
59.7 |
1 |
10,000 |
64,000 |
238,000 |
1,260,000 |
2 |
10,000 |
54,000 |
258,000 |
1,270,000 |
|
3 |
10,000 |
56,000 |
222,000 |
1,230,000 |
|
mean |
10,000 |
58,000 |
239,000 |
1,253,000 |
|
% control |
100 |
109 |
144 |
102 |
|
124 |
1 |
10,000 |
48,000 |
248,000 |
1,300,000 |
2 |
10,000 |
46,000 |
200,000 |
1,150,000 |
|
3 |
10,000 |
54,000 |
214,000 |
1,100,000 |
|
mean |
10,000 |
49,000 |
221,000 |
1,183,000 |
|
% control |
100 |
92 |
133 |
96 |
|
239 |
1 |
10,000 |
50,000 |
226,000 |
970,000 |
2 |
10,000 |
58,000 |
258,000 |
1,160,000 |
|
3 |
10,000 |
54,000 |
228,000 |
1,570,000 |
|
mean |
10,000 |
54,000 |
237,000 |
1,233,000 |
|
% control |
100 |
102 |
143 |
100 |
|
478 |
1 |
10,000 |
48,000 |
224,000 |
1,160,000 |
2 |
10,000 |
58,000 |
298,000 |
1,140,000 |
|
3 |
10,000 |
48,000 |
248,000 |
1,170,000 |
|
mean |
10,000 |
51,000 |
257,000 |
1,157,000 |
|
% control |
100 |
96 |
155 |
94 |
|
933 |
1 |
10,000 |
42,000 |
182,000 |
860,000 |
2 |
10,000 |
52,000 |
216,000 |
1,030,000 |
|
3 |
10,000 |
56,000 |
224,000 |
840,000 |
|
mean |
10,000 |
50,000 |
207,000 |
910,000 |
|
% control |
100 |
94 |
125 |
74 |
Average specific growth rate from the toxicity test with 4-chlorophthalic anhydride and the freshwater alga, Selenastrum capricornutum
Measured Concentration of 4-CLPA(mg/L) |
Average Specific Growth Rate |
|||
Hour of Exposure |
||||
24 |
48 |
72 |
||
Control |
mean |
0.069 |
0.059 |
0.067 |
59.7 |
mean |
0.073 |
0.066 |
0.067 |
% control |
106 |
112 |
100 |
|
124 |
mean |
0.066 |
0.064 |
0.066 |
% control |
96 |
108 |
99 |
|
239 |
mean |
0.070 |
0.066 |
0.067 |
% control |
101 |
112 |
100 |
|
478 |
mean |
0.068 |
0.068 |
0.066 |
% control |
99 |
115 |
99 |
|
933 |
mean |
0.067 |
0.063 |
0.063 |
% control |
97 |
107 |
94 |
Applicant's summary and conclusion
- Conclusions:
- The 72-h EC50 value was determined to be >1000 mg/L and the 72-h NOEC value was 500 mg/L.
- Executive summary:
The toxicity towards freshwater algae was determined in a study according to OECD TG 201 and in compliance with GLP criteria. In this study, exponentially growing freshwater alga (Pseudokirchneriella subcapitata) were exposed to nominal test substance concentrations of 0, 65, 130, 250, 500, and 1,000 mg/L for 72 hours under static conditions. Test concentrations were analytically verified at the start and the end of exposure and measured concentrations remained within ±20% of nominal. The cell concentration in each flask was determined at the start of the test and after 24, 48, and 72 hours exposure. The 72-h ErC50 value for growth rate (ErC50) and biomass (cells/mL) was determined at >1000 mg/L. The 72 hour NOEC is 500 mg/L 4-chlorophthalic anhydride when determined using the number of cells/mL or the average specific growth rate when treatment data are compared to control data.
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.