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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 275-809-7 | CAS number: 71662-46-9
- 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 soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- from 1994-08-25 to 1994-09-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)
- Principles of method if other than guideline:
- Toxizitaetstest fuer Regenwuermer nach 88/302 EWG
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Method of mixing into soil: The test substance was mixed with silica sand and afterwards added to soil substrate in a plastic bag. Water was added to a theoretical water content of approx. 40% and the substrate was thoroughly mixed
- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: earthworm
- Source: Eisenia GmbH&Co. Produktions- und Vertrieb KG, Kapellenstraße 25, Wiesbaden, Germany
- Age at test initiation: at least 2 months
- Weight at test initiation: 307-594 mg
ACCLIMATION
- Acclimation period: not mentioned - Study type:
- laboratory study
- Substrate type:
- other: mixture of peat and horse dung (1:1)
- Limit test:
- yes
- Total exposure duration:
- 14 d
- Post exposure observation period:
- no
- Test temperature:
- 20 ± 2 °C
- pH:
- 5.5
- Moisture:
- 37 - 39 %
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): Makrolon cages with perforated plexiglass covers, size not mentioned
- Amount of soil or substrate: not mentioned
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: not applicable
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): mixture of peat and horse dung (1:1)
- Organic carbon (%): not mentioned
- Maximum water holding capacity (in % dry weight): not mentioned
- CEC: not mentioned
- Pretreatment of soil: not mentioned
- Storage (condition, duration): fresh prepared
- Stability and homogeneity of test material in the medium: not mentioned
OTHER TEST CONDITIONS
- Photoperiod: 24 h
- Light intensity: approx. 400-600 lux
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable, limit test
- Range finding study: not performed - Nominal and measured concentrations:
- nominal concentration, not measured: 1000 mg/kg dry soil
- Reference substance (positive control):
- yes
- Remarks:
- chloracetamide, historical data
- Duration:
- 14 d
- Dose descriptor:
- LC10
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- - Mortality at end of exposure period: 0/40 (0%) after 7 days; 1/40 (2.5%) after 14 days
- Total mass of adults at beginning of test: 406 mg (mean)
- Changes in body weight of live adults (% of initial weight) at end of exposure period: not mentioned
- No. of offspring produced: not mentioned
- No. of unhatched cocoons: not mentioned
- Morphological abnormalities: not mentioned
- Behavioural abnormalities: not mentioned
- Other biological observations: not mentioned - Results with reference substance (positive control):
- RESULTS: TEST WITH REFERENCE SUBSTANCE (historical data, 1994-03-03 until 1994-03-17)
- Concentrations: 0, 10, 30 and 100 mg 2-chloroacetamide/kg dry soil
- Results (mortality): 10 mg/kg: 0/20 (0%) after 14 days; 30 mg/kg: 18/20 (90%) after 7 and 14 days, respectively; 100 mg/kg: 17/20 (85%) after 7 and 14 days, respectively. - Reported statistics and error estimates:
- no statistics performed
- Validity criteria fulfilled:
- yes
- Conclusions:
- The structurally related substance 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters was not toxic under test conditions at a limit concentration of 1000 mg/kg dry soil.
- Executive summary:
The acute toxicity of the structurally related substance 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters (WITAMOL 110) to the earthworm eisenia foetida was determined during a 14 day exposure period according to EEC Methods for Determination of Ecotoxicity, Directive 88/302/EEC. For the limit test with a concentration of 1000 mg/kg dry soil, the test substance was mixed with silica sand and afterwards added to soil substrate. After 7 and 14 days the effects of the test substance on the earthworms' survival were examined.
No mortality occurred at the tested concentration after 7 and 14 days. The 14 day LC50 of WITAMOL 110 to Eisenia foetida was observed to be > 1000 mg/kg dry soil.
- Endpoint:
- toxicity to soil macroorganisms except arthropods: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
- Deviations:
- yes
- Remarks:
- Food was provided on day 0 (test start) instead of day 1 due to the good experience with this procedure.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Tightly closed, at a dry and good ventilated place
- Solubility and stability of the test substance in the solvent/vehicle: Not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None. - Analytical monitoring:
- yes
- Details on sampling:
- The test item was analysed in the treated soil subsequently to its preparation on day 0 and on day 55.
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Method of mixing into soil : The respective test item amount for each concentration was weighed out, dissolved in demineralised water and added to the artificial soil. Additional demineralised water was added to adjust the humidity of the artificial soil to a moisture of 40 – 60 % of the WHCmax. Subsequently, the test medium was mixed thoroughly to ensure a homogenous distribution and a soil amount corresponding to about 600 g soil DW will be filled into the test vessels.
- Controls: Untreated artificial soil - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Earthworms
- Source: In-house culture
- Age at test initiation: 2-12 months (difference of age did not deviate by more than 1 month)
- Weight at test initiation (range): 0.40 to 0.54 g - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 56 d
- Test temperature:
- 18 - 23°C (The room temperature increased to 23°C for about 7 hours. This deviation is considered to have no impact on quality and integrity of the study.)
- pH:
- 5.7 - 6.1
- Moisture:
- 24.3 - 29.7% (The soil moisture deviated by more than 10 % from the initial value. This deviation is considered to have no impact on quality and integrity of the study.)
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): Round plastic boxes with an inner diameter of 15.0 cm, corresponding to a bottom surface area of 177 cm2 and a height of 14 cm.
- Amount of soil or substrate: 610 g per test container
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8
- No. of replicates per vehicle control: Not applicable
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- The artificial soil consisted of the following components: 10 % peat, air-dried and finely ground, 20 % kaolin, kaolinite content > 30 %, 69 % air-dried quartz sand (sand with > 50 % particle size of 0.05 - 0.2 mm), 0.38 % calcium carbonate (CaCO3) to achieve a pH of 6.0.
- Pretreatment of the soil: Two days before experimental starting, the artificial soil (22 kg) was pre-moistened by adding 2442 g demineralised water to achieve a moisture content corresponding to 27 % of the maximum water capacity of the artificial soil. The moistened soil was kept covered to prevent evaporative water losses prior to the start of exposure.
OTHER TEST CONDITIONS
- Photoperiod: 16h
- Light intensity: 571 +/-93 lx
EFFECT PARAMETERS MEASURED:
A) no obvious pathological symptoms
B) no reaction to touch
C) no negative phototactical reaction
D) spontaneous segmentation and separation
E) spasmodic winding
F) yellow excretion from the oral aperture
G) ulcer and skin bleedings
H) dead earthworms
VEHICLE CONTROL PERFORMED: No
TEST CONCENTRATIONS
- Nominal test concentrations: 20 – 62.5 – 125 – 250 – 500 – 1000 mg/kg SDW
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study
- Test concentrations: 1 – 10 – 100 – 1000 mg/kg SDW
- Results used to determine the conditions for the definitive study: 10% mortality at 1000 mg test item/kg soil dry weight, no other effects observed. - Nominal and measured concentrations:
- 20, 62.5, 125, 250, 500, 1000 mg/kg SDW (nominal)
20.2-23.7, 64.1 - 91.5, - Reference substance (positive control):
- yes
- Key result
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 56 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 500 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 56 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 56 d
- Dose descriptor:
- EC10
- Effect conc.:
- 504 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 56 d
- Dose descriptor:
- other: EC20
- Effect conc.:
- 819 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- - Changes in body weight of live adults (% of initial weight) at end of exposure period: No significant differences in bodyweight compared to control.
- No. of offspring produced: The mean number of juveniles in the control was 118. The average number of juveniles in the treated groups ranged from 88 to 126
- No. of unhatched cocoons: None
- Morphological abnormalities: None
- Behavioural abnormalities: None
- Other biological observations: None
- Mortality at end of exposure period: None - Results with reference substance (positive control):
- - Results with reference substance valid?
- Relevant effect levels: Significant effects of Carbendazim were observed between 1 and 5 mg a.s./kg soil DW, the validity criteria was fulfilled. - Validity criteria fulfilled:
- yes
- Conclusions:
- No mortalities, significant pathological symptoms or changes in the behaviour of adult earthworms were observed in the control or any test item treatments. The reproduction was significantly effected at 1000 mg/kg SDW and therefore the lowest NOEC of the test item based on reproduction was determined to be 500 mg/kg SDW. The corresponding EC10- and EC20-values for reproduction rate were determined to be 504 and 819 mg/kg SDW, respectively.
All validity criteria recommended by the test guidelines were fulfilled. - Executive summary:
Effects of 1,2-Benzenedicarboxylic acid,di-C8-10-alkyl esters on mortality, biomass and the reproductive potential of the earthworm species Eisenia fetida (Annelida, Lumbricidae) were determined according to OECD 222 (2004).
The study was conducted under static conditions over 8 weeks with the test item concentrations 20 – 62.5 – 125 – 250 – 500 – 1000 mg/kg SDW. Each application rate was mixed into artificial soil containing 10 % peat. A control using untreated artificial soil was tested under the same conditions as the test item treatments. 80 test organisms were inserted into 8 control replicates and 40 test organisms were divided into 4 replicates for each treatment (10 earthworms per replicate). They had an individual body weight between 0.40 and 0.54 g at the experimental start.
Each concentration level and the control were analysed via LC-MS analysis after preparation at the start of the exposure (day 0) and at the end of the exposure (day 56).
The measured concentrations of all active ingredients of the test item were within the range of 78 to 146% of the nominal values at the start of the exposure and within the range of 16 to 36 % at the end. For the test item 3 components were analytical verified. One of them, the C10C10 part, results in varying recovery’s. For the other components the results were homogeneous. Therefore the nominal test item concentrations were used for EC calculations.
After 28 days of exposure in soil, neither earthworm mortalities nor significant pathological symptoms or changes in the behaviour of adult earthworms were observed in the control or test item treatments.
There were no statistically significant differences in earthworm body weights in all treatment rates compared to the control. After a further four weeks, the reproduction rate (average number of juveniles produced) was 118 in the control and ranged from 88 to 126 in the test item treatment rates. Compared to the control, no statistically significant reduction of reproduction rate was observed in the test item concentrations 20 to 500 mg/kg SDW. However, at the test item concentration 1000 mg/kg SDW the earthworm reproduction was statistically significantly reduced. Overall, the NOEC of the test item concerning mortality, biomass and reproduction was determined to be 500 mg/kg SDW. The EC10/20-values for reproduction rate were determined to be 504 and 819 mg/kg SDW, respectively.
All validity criteria recommended in the test guideline were fulfilled.
Referenceopen allclose all
RESULTS: EXPOSED
- Nominal concentrations: 1000 mg/kg dry soil
- Effect data (Mortality): 0/40 (0%) after 7 days; 1/40 (2.5%) after 14 days
RESULTS: CONTROL
- Effect data (Mortality): 0/40 (0%) after 7 and 14 days
Measured Concentrations and Percent of the Nominal Concentrations of the Test Item LINPLAST 810 P during the Definitive Test at the Start of the Exposure (day 0)
Sampling date/Start of analysis | 2016-12-14 | 2016-12-14 | 2016-12-14 | |||
Nominal concentration | C8C8 component | C8C10 component | C10C10 component | |||
[mg/kg SDW] | Meas. conc. [mg/kg SDW] |
% | Meas. conc. [mg/kg SDW] |
% | Meas. conc. [mg/kg SDW] |
% |
1000 |
1152 |
115 |
1317 |
132 |
1283 |
128 |
500 |
577 |
115 |
500 |
100 |
467 |
93 |
250 |
262 |
105 |
259 |
104 |
207 |
83 |
125 |
135 |
108 |
134 |
107 |
97 |
78 |
62.5 |
64 |
103 |
71 |
114 |
92 |
146 |
20.0 |
20 |
101 |
20 |
102 |
24 |
118 |
Control | < LOQ |
< LOQ |
< LOQ |
Reproduction Rate (Number of Juveniles after 56 days)
Application rate [mg/kg SDW] | Mean ± SD | CV [%] | [%] of control | Sig. |
Control | 118 ± 23.9 | 20.3 | - | - |
20.0 | 107 ± 15.3 | 14.3 | 90.7 | No |
62.5 |
126 ± 10.3 |
8.17 |
107 |
No |
125 |
107 ± 7.68 |
7.18 |
90.7 |
No |
250 |
122 ± 17.8 |
14.6 |
103 |
No |
500 |
99 ± 16.0 |
16.1 |
83.9 |
No |
1000 |
88 ± 15.3 |
17.3 |
74.6 |
Yes |
Description of key information
(Short-term) LC50 > 1000 mg/kg dry soil
(Long-term) NOEC = 500 mg/kg dw, EC10 = 504 mg/kg dw
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 500 mg/kg soil dw
Additional information
In the Eisenia fetida study with 1,2 -Benzenedicarboxylic acid, di-C8 -10 -alkyl esters after 7 and 14 d no mortality up to the highest concentration of 1000 mg/kg was observed. This study is supported by the result with the structurally related substance 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters with a LC10 in excess of 1000 mg/kg dry soil.
In the chronic earthworm study with 1,2 -Benzenedicarboxylic acid, di-C8 -10 -alkyl esters, no mortalities, significant pathological symptoms or changes in the behaviour of adult earthworms were observed in the control or any test item treatments. The reproduction was significantly affected at 1000 mg/kg SDW and therefore the lowest NOEC of the test item based on reproduction was determined to be 500 mg/kg SDW.
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.