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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-583-1 | CAS number: 108-44-1
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Concept NEN report 6502 from the Dutch Standard Organization (1980)
- Deviations:
- yes
- Remarks:
- : Exposure time and number of organisms per group
- Principles of method if other than guideline:
- additionally: Canton et al. (1975)
- GLP compliance:
- not specified
- Analytical monitoring:
- yes
- Details on sampling:
- -Only the lowest and highest tested concentrations were measured by GC
- Vehicle:
- not specified
- Details on test solutions:
- - were prepared in "Dutch Standard water", (DSW, Canton and Sloff, 1982)
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- -Age at study initiation: <1d
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 16 d
- Remarks on exposure duration:
- 3-4 broods
- Hardness:
- ca. 1 mmol/L
- Test temperature:
- 18-20°C
- Nominal and measured concentrations:
- ration of concentrations: 3.2
- Details on test conditions:
- -test volume per vessel: 1 L
-number of replicates per concentration: 2
-renewing rate: 3 times a week
-15 daphnids per vessel
-feeding with chlorella spec. - Reference substance (positive control):
- not specified
- Duration:
- 16 d
- Dose descriptor:
- EC50
- Effect conc.:
- 0.043 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: corrected for measured recoveries
- Duration:
- 16 d
- Dose descriptor:
- EC50
- Effect conc.:
- 0.038 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Validity criteria fulfilled:
- not specified
- Remarks:
- Since the test is poorly reported the validity criteria cannot be assessed sufficiently. Nevertheless the test is considered as valid based on the data given.
Reference
NOEC ist not reported.
Description of key information
The long-term toxicity of m-toluidine towards invertebrates was
investigated in a 21 d assay. A NOEC of 0.01 mg/L for reproduction was observed.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.01 mg/L
Additional information
Three long-term toxicity studies of m-toluidine to aquatic invertebrates are available.
First, the long-term toxicity of m-toluidine towards invertebrates was investigated in a 16 d assay. A NOEC of 0.012 mg/L was observed having the growth of the test animals as endpoint. The method used was NEN 6502 standard protocoll from the Dutch Standard Organization (1980) which follows the general principles of the OECD TG 202 (1984): Daphnia sp., Acute Immobilisation Test and Reproduction Test.
Daphnids were reared at a laboratory, and were less than 24 hours old at the start of the experiment. Stock solutions were prepared in ethanol. Test solutions were prepared in "Dutch Standard Water" (DSW). Daphnids in blanks were exposed to 100 µl/L ethanol. Concentrations of the test substance increased with a factor of 1.8. At the start of the experiment 20 -25 daphnids were placed into 1 L of the test solution under semi-static conditions. After 16 d of exposure to the test solutions, the length of each daphnid was determined. NOEC was determined using Student's test, and was defined as the highest concentration tested that did not give a singnificant (P < 0.05) decrease of length in duplicate experiments. EC10 was determined by minimum logit-X2 analysis. Due to a high deviation in length for concentrations lower or around NOEC, the value of NOEC and EC10 are similar. The values are assumed to base on nominal concentrations as no analytical monitoring is described.
The study cannot be fully validated due to limited reporting. No information is given if the first young was born after a maximum of nine days in the controls and the average cumulative number of young per female in the controls after three broods, was >/= 20. Nevertheless, the test duration was 16 days and it is assumed that the test duration was long enough for the development of at least three broods and the number of young per female was > 20 animals. In conclusion the study is scored to be reliable and a weight of evidence approach is applied.
Second, a study was performed to assess the effects of the substance on the reproductive output of parthenogenetic Daphnia magna under semi static conditions. The study was conducted according to the OECD Guideline 202 ( Acute immobilisation Test and reproduction Test, 1984) by EA, Japan: "Investigation of the Ecotoxicological Effects of OECD High Production Volume Chemicals", Office of Health Studies, Environmental Health Department, Environment Agency, Japan.
Young female Daphnia, aged less than 24 hours at the start of the test, were exposed to five concentrations, nominally 0.010, 0.032, 0.1, 0.32 and 0.1 mg/L of the test substance dissolved in water. Stock solution was prepared with DMSO, resulting in a final concentration of 200 mg/L. Controls with and without this vehicle was taken for test. After a 21d-exposure period, the total number of living offspring produced per parent animal alive at the end of the test was assessed. The reproductive output of the Daphnia exposed to the test item was compared to that of the control in order to determine the Lowest Observed Effect Loading (LOEL) and the No Observed Effect Loading (NOEL). The values are based on nominal concentration as no analytical monitoring was performed. Additionally, the survival of the parent Daphnia and the time to production of first brood was determined. The present study shows deficiencies concerning test organisms. A validity criterion of the OECD TG 202 (1984) was that the average cumulative number of young per female in the controls after three broods, should be >/= 20. As the number of offspring solely accounts for 32 in the present study, the validity criterion set out by the guideline is just fulfilled, but based on experience the number of offspring per adult normally accounts for approx. 80 to 100 animals after 21 days of exposure. This validity criterion is adjusted in the OECD guideline 211, were the number of offspring per adult should account for 60.
In conclusion the study is scored to be reliable and a weight of evidence approach is applied.
Further, the effect of m-toluidine on inhibition of reproduction of Daphnia magna was investigated according the NEN 6502 from the Dutch Standard Organisation (1980). The concentration at 50% inhibition of reproduction (EC50) was calculated based on the added quantities as well as on experimental measured concentrations after 16 days of exposure.
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.