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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 945-713-6 | 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
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Test method according to US EPA (1975): "Methods for acute toxicity tests with fish, macroinvertebrates and amphibiens".
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA (1975): "Methods for acute toxicity tests with fish, macroinvertebrates and amphibiens"
- Deviations:
- not specified
- GLP compliance:
- no
- Analytical monitoring:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- Cyprinodon variegatus
- Details on test organisms:
- TEST ORGANISM
- Common name: Sheepshead Minnows
- Source: Animals were hatched and reared at BMRL or obtained from the EPA's Environmental Research Laboratory, Gulf Breeze, FL.
- Age at study initiation (mean and range, SD): 14-28 days old posthatch
- Length at study initiation (length definition, mean, range and SD): 8 - 15 mm standard length
- Weight at study initiation (mean and range, SD):
- Method of breeding:
- Maintenance of the brood fish:
ACCLIMATION
- Acclimation conditions (same as test or not): Flowing, filtered (10-µm) seawater
- Type and amount of food/Feeding frequency: Fish were fed 24-h Artemia salina nauplii (San Francisco Bay Brand) daily until they were used as test animals.
- Health during acclimation (any mortality observed): Fish mortality during the 48-h period immediately before each test was less than 3% and all fish tested appeared to be in good condition.
FEEDING DURING TEST: No - Test type:
- static
- Water media type:
- saltwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Test temperature:
- 25-31 ºC
- Salinity:
- 1.0-3.1 %
- Nominal and measured concentrations:
- No data on test concentrations
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Tests were conducted in either 4-L glass jars that contained 3 L of test solution or 19-L glass jars that contained 15 L
- Aeration: No
- No. of organisms per vessel: 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: All dilution water was filtered (5-µm), natural seawater of ambient salinity.
- Intervals of water quality measurement: The dissolved oxygen concentration was measured in each test container at initiation of testing and daily thereafter; pH was measured in the control and the low and high test concentrations at the initiation and after 96 h of testing.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality was recorded at 24, 48, 72, and 96 h. - Reference substance (positive control):
- not specified
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: (95% confidence limits: 1.6-2.2 ppm)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: (95% confidence limits: 1.6-2.4 ppm)
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: (95% confidence limits: 1.6-2.4 ppm)
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: (95% confidence limits: 1.0-3.2 ppm)
- Reported statistics and error estimates:
- Based on the results of the tests, 24-, 48-, 72-, and 96-h LC50's and their 95% confidence limits were calculated when possible. Calculations were performed with a Hewlett Packard Model 9815A calculator programmed (STEPHAN 1977 and 1978 personal communication) to scan the data base and to select the most appropriate of three statistical methods in the following order: moving average angle analysis, probit analysis, or binomial probability. The method selected was determined by the characteristics of the data, that is, the presence or absence of 0% and 100% mortality and the number of concentrations in which >0%<100% mortality occurred. The computer scanned the data, identified the most suited method, and performed the analyses. No correction was made for control mortality.
- Sublethal observations / clinical signs:
The LC50 (96 h) was 1.9 ppm (basis for effect: mortality). The NOEC was 1.0 ppm.
- Validity criteria fulfilled:
- not specified
- Remarks:
- (No data on control results. There is no evidence that test substance concentration had been maintained throughout the test period).
- Conclusions:
- The LC50 (96 h) was 1.9 ppm (basis for effect: mortality).
- Executive summary:
A marine toxicity static test were conducted at EG&G Bionomics Marine Research Laboratory (BMRL) with sheepshead minnows (Cyprinodon variegatus). Test method was according to US EPA (1975): "Methods for acute toxicity tests with fish, macroinvertebrates and amphibiens". Camphene was tested for 96 hours at 25 -31 ºC. Mortality was recorded at 24, 48, 72, and 96 h. The 96 h-LC50 was 1.9 ppm (basis for effect: mortality). The NOEC was 1.0 ppm.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA (1975): "Methods for acute toxicity tests with fish, macroinvertebrates and amphibiens"
- Deviations:
- not specified
- GLP compliance:
- no
- Analytical monitoring:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- Cyprinodon variegatus
- Test type:
- static
- Water media type:
- saltwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Nominal and measured concentrations:
- No data on test concentrations
- Reference substance (positive control):
- not specified
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: (95% confidence limits: 1.6-2.2 ppm)
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The LC50 (96 h) was 1.9 ppm (basis for effect: mortality).
- Executive summary:
A marine toxicity static test was conducted with sheepshead minnows (Cyprinodon variegatus). The 96 h-LC50 was 1.9 ppm (basis for effect: mortality) with 1.6 -2.2 ppm 95% confidence limits.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance camphene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.9 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Read-across from an analogue
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: read-across from an analogue for which LC50 (96 h) = 1.9 mg/L (95% confidence limits: 1.6-2.2 ppm)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Read-across from an analogue
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: read-across from an analogue for which NOEC (96 h) = 1.0 mg/L
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Read-across from an analogue
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: read-across from an analogue for which LC50 (72 h) = 2.0 mg/L (95% confidence limits: 1.6-2.4 ppm)
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Read-across from an analogue
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: read-across from an analogue for which LC50 (48 h) = 2.0 mg/L (95% confidence limits: 1.6-2.4 ppm)
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.8 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Read-acros from an analogue
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: read-across from an analogue for which LC50 (24 h) = 1.8 mg/L (95% confidence limits: 1.0-3.2 ppm)
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Based on the read-across approach from the analogue camphene, the LC50 (96 h) of reaction mass was determined to be 1.9 ppm (basis for effect: mortality).
- Executive summary:
A marine toxicity static test were conducted at EG&G Bionomics Marine Research Laboratory (BMRL) with sheepshead minnows (Cyprinodon variegatus). Test method was according to US EPA (1975): "Methods for acute toxicity tests with fish, macroinvertebrates and amphibiens". Camphene was tested for 96 hours at 25 -31 ºC. Mortality was recorded at 24, 48, 72, and 96 h. The 96 h-LC50 was 1.9 ppm (basis for effect: mortality). The NOEC was 1.0 ppm. Based on these results, the read-across approach was applied and the 96 h-LC50 of the reaction mass was determined to be 1.9 ppm (basis for effect: mortality) and the NOEC 1.0 ppm.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance camphene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.9 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- other: Read-across from an analogue
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: read-across from an analogue for which LC50 (96 h) = 1.9 mg/L (95% confidence limits: 1.6-2.2 ppm)
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Based on the read-across approach from the analogue camphene, the LC50 (96 h) of reaction mass was determined to be 1.9 ppm (basis for effect: mortality).
- Executive summary:
A marine toxicity static test was conducted with sheepshead minnows (Cyprinodon variegatus). The 96 h-LC50 was 1.9 ppm (basis for effect: mortality) with 1.6 -2.2 ppm 95% confidence limits. Based on these results, the read-across approach was applied and the 96 h-LC50 of the reaction mass was determined to be 1.9 ppm (basis for effect: mortality).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 March 2018 - 19 March 2018
- 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 (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0 (control), 0 (vehicle control) and 50 mg/L
- Sampling method: A known volume of sample (10 mL) was taken in a separating funnel and to this 30 mL of dichloromethane was added.
- Sample storage conditions before analysis: not applicable - Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: An amount of 2500 mg test item was made up to 5 mL of acetone to obtain nominal concentration of 500.0 mg/mL (Stock A). Volume of 400 µL from the stock A was diluted to 4 L with RO water in fish tank to obtain the nominal test concentration of 50.0 mg test item/L.
- Controls: RO water and RO water + acetone
- Chemical name of vehicle: acetone
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): 0.1mL/L - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: Fish-O-Fish-Aquarium
- Length at study initiation: 1.4 ± 0.2 cm
ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: "Gemma Micro 500 ZF”, Manufactured by Trouw France SA, 52 ter, Rue Jacob, 02140 Vervins, France.
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): No signs of physical or behavioural abnormalities or mortalities of fish were observed.
FEEDING DURING TEST
None during test period - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
- Hardness:
- 85.4 ± 5.4 mg CaCO3/L
- Test temperature:
- initial= 21.7 ± 0.3ºC; final= 21.7 ± 0.2ºC
- pH:
- initial= 7.34 ± 0.12; final = 7.54 ± 0.22
- Dissolved oxygen:
- initial=90.4 ± 0.9 %; final=87.8 ± 1.2 %
- Nominal and measured concentrations:
- Nominal concentrations: 0 (control), 0 (vehicle control) and 50 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass tank
- Material, size, headspace, fill volume: glass, 8 L capacity, 4 L fill volumen
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): 24 h (semi-static)
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): one
- No. of vessels per control (replicates): one
- No. of vessels per vehicle control (replicates): one
- Biomass loading rate: maximun 0.6 g/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: RO water
- Intervals of water quality measurement: Temperature, pH and dissolved oxygen content of the test media were measured daily before and after each renewal of the media with freshly prepared test solution. Total hardness was analysed daily for each renewal of the diluent water during the study period.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light and 8 h dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :Fish were observed at 3, 6, 24, 48, 72 and 96 h of exposure. Recorded parameters included behavioural responses, clinical signs and mortality.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: limit test
- Justification for using less concentrations than requested by guideline: no mortality found in a preliminary range finding study.
- Range finding study
- Test concentrations: 0.0 (control), 0.0 (vehicle Control), 0.1, 1.0, 10.0 and 50.0 mg test item/L
- Results used to determine the conditions for the definitive study: The cumulative percent mortalities at 96 h observed were 0, 0, 0, 0, 0 and 0 at the test concentrations of 0.0 (control), 0.0 (vehicle Control), 0.1, 1.0, 10.0 and 50.0 mg test item/L, respectively. Based on the results of this preliminary range finding study, the main study was restricted to limit study. The limit study was conducted with single test concentration of 50.0 mg/L along with control and vehicle control. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: Fish exposed to 0.0 (control), 0.0 (vehicle control) and 50.0 mg/L did not exhibit any treatment related behavioral response
- Mortality of control: No mortality was observed over a period of 96 h in the control and vehicle control groups - Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- As no mortality was observed at the test concentration of 50.0 mg/L, probit analysis was not carried out.
- Sublethal observations / clinical signs:
Table 1: Mortalities
Group
Test Concentration
(mg/L)
Percentage Mortality of Fish at
Cumulative Mortality
(%) at 96 h
3 h
6 h
24 h
48 h
72 h
96 h
G1
0.0 (Control)
0
0
0
0
0
0
0
G2
0.0
(Vehicle control)
0
0
0
0
0
0
0
G3
50.0
0
0
0
0
0
0
0
Table 2: Behavioural response
Group
Test Concentration
(mg/L)
Noof
Fish Used
Behavioral Response observed at
3 h
6 h
24 h
48 h
72 h
96 h
G1
0.0 (Control)
10
1(10)
1(10)
1(10)
1(10)
1(10)
1(10)
G2
0.0
(Vehicle control)
10
1(10)
1(10)
1(10)
1(10)
1(10)
1(10)
G3
50.0
10
1(10)
1(10)
1(10)
1(10)
1(10)
1(10)
Behavioral Response: 1 = Normal
Note: Figures presented outside parentheses refer the clinical symptom and inside parentheses refer the total number of fish
Table 3: Mean of Physico-Chemical Parameters of Test Media
Group
Test Concentration
(mg/L)
pH
Temperature (°C)
Dissolved Oxygen (%)
Initial
Final
Initial
Final
Initial
Final
Mean
SD
Mean
SD
Mean
SD
Mean
SD
Mean
SD
Mean
SD
G1
0.0 (Control)
7.26
0.07
7.48
0.15
21.6
0.3
21.5
0.2
91.6
1.2
87.5
2.5
G2
0.0
(Vehicle control)
7.33
0.09
7.55
0.19
21.7
0.2
21.7
0.1
91.5
0.9
88.1
1.4
G3
50.0
7.34
0.12
7.54
0.22
21.7
0.3
21.7
0.2
90.4
0.9
87.8
1.2
Key: Initial = 0 h, Final = 24 h, SD = Standard deviation
Table 4: Total Hardness (mg/L as CaCO3)
Total Hardness (mg/L)
Mean
SD
85.4
5.4
- Validity criteria fulfilled:
- yes
- Remarks:
- (mortality in control < 10%; semi-static test conditions; dissolved O2 concentration > 60% of air saturation value; concentration of the substance >80% of the nominal concentration)
- Conclusions:
- In a short-term toxicity test to zebrafish, Danio rerio, the 96h-LC50 of the test substance was found to be greater than 50.0 mg/L.
- Executive summary:
An acute aquatic toxicity study with zebrafish, Danio rerio, was conducted on test item according to OECD guideline 203, following GLP. A preliminary range finding study was conducted with test concentrations of 0.0 (control), 0.0 (vehicle Control), 0.1, 1.0, 10.0 and 50.0 mg/L for a period of 96 h with ten fish in each group. Based on no mortalities found in this preliminary study, the main test was restricted to limit study conducted with single test concentration of 50.0 mg/L. Reverse osmosis (RO) water was used as test medium. In the previous solubility study the test item was found to be insoluble in RO water and acetone was selected as the vehicle. Thus, the main test was conducted with test concentrations of 0.0 (control), 0.0 (vehicle Control) and 50.0 mg/L for a period of 96 h in semi-static conditions with ten fish in each group. The test solutions were changed every 24 h with freshly prepared solutions. The test solutions were not aerated during the exposure. A validated analytical method based on gas chromatography was used to monitor the concentration and stability of the main active ingredients in the test solution at 0 and 24 h of first renewal during main study. The active ingredient concentration in the test solution was within acceptable limit (> 80% of nominal concentration). All validity criteria were fulfilled. No mortality and no treatment related behavioural response were observed over a period of 96 h at the test concentration of 50.0 mg/L as well as in the control and vehicle control groups. Thus, LC50 (96 h), NOEC and LOEC to fish of the test substance were found to be greater than 50.0 mg/L.
Referenceopen allclose all
Description of key information
Key study. Test method according to OECD 203, GLP study. The 96h-LC50 of the test substance to zebrafish, Danio rerio, was found to be greater than 50.0 mg/L.
Supporting studies: Read-across approach. camphene. Test method according to US EPA (1975): "Methods for acute toxicity tests with fish, macroinvertebrates and amphibiens". Based on the read-across approach from the analogue camphene, the LC50 (96 h) of reaction mass to sheepshead minnows (Cyprinodon variegatus) was determined to be 1.9 ppm.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 50 mg/L
Additional information
Key study. An acute aquatic toxicity study with zebrafish, Danio rerio, was conducted on test item according to OECD guideline 203,following GLP. A preliminary range finding study was conducted with test concentrations of 0.0 (control), 0.0 (vehicle Control), 0.1, 1.0, 10.0 and 50.0 mg/L for a period of 96 h with ten fish in each group. Based on no mortalities found in this preliminary study, the main test was restricted to limit study conducted with single test concentration of 50.0 mg/L. Reverse osmosis (RO) water was used as test medium. In the previous solubility study the test item was found to be insoluble in RO water and acetone was selected as the vehicle. Thus, the main test was conducted with test concentrations of 0.0 (control), 0.0 (vehicle Control) and 50.0 mg/L for a period of 96 h in semi-static conditions with ten fish in each group. The test solutions were changed every 24 h with freshly prepared solutions. The test solutions were not aerated during the exposure. A validated analytical method based on gas chromatography was used to monitor the concentration and stability of the main active ingredients in the test solution at 0 and 24 h of first renewal during main study. The active ingredient concentration in the test solution was within acceptable limit (> 80% of nominal concentration). All validity criteria were fulfilled. No mortality and no treatment related behavioural response were observed over a period of 96 h at the test concentration of 50.0 mg/L as well as in the control and vehicle control groups. Thus, LC50 (96 h), NOEC and LOEC to fish of the test substance were found to be greater than 50.0 mg/L.
Supporting studies: Read-across approach. camphene. A marine toxicity static test were conducted at EG&G Bionomics Marine Research Laboratory (BMRL) with sheepshead minnows (Cyprinodon variegatus). Test method was according to US EPA (1975): "Methods for acute toxicity tests with fish, macroinvertebrates and amphibiens". Camphene was tested for 96 hours at 25 -31 ºC. Mortality was recorded at 24, 48, 72, and 96 h. The 96 h-LC50 was 1.9 ppm (basis for effect: mortality). The NOEC was 1.0 ppm. Based on these results, the read-across approach was applied and the 96 h-LC50 of the reaction mass was determined to be 1.9 ppm (basis for effect: mortality) and the NOEC 1.0 ppm.
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.