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Diss Factsheets
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EC number: 949-740-4 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 26 Feb - 05 April 2007
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Non-GLP study conducted to a method similar to OECD 423 but with methodological deficiencies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- yes
- Remarks:
- only 7 days observations
- GLP compliance:
- no
- Remarks:
- The experiment was performed in 2007, therefore pre-dating 1st June 2008 cut off after which GLP compliance is necessary for toxicological tests. The report is dated 2019, because this is when the report itself was finalised.
- Test type:
- other: Method similar to acute toxicity classic
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 126482-45-2
- Test material form:
- liquid
- Details on test material:
- Storage of test material: in a tightly sealed container, under refrigeration
Informal name: MEL-2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Slc:Wistar [SPF]
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC , Inc.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 103 - 107 g
- Fasting period before study: yes (17 hour)
- Housing: Animals were individually housed in wire mesh cage, 19.7W×26.3D×18.0H (cm), One animal/cage (during the study).
- Diet (e.g. ad libitum): CRF-1 (Oriental Yeast, Lot No. 061108) sterilized by irradiated ad libitum (except when fasted).
- Water (e.g. ad libitum): tap water from automated water supply system ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0−26.0°C
- Humidity (%): 35.0−75.0%
- Air changes (per hr): 12 or more times air changes per hour
- Photoperiod (hrs dark / hrs light): 12 : 12
IN-LIFE DATES: 26/2/ 2007 – 15/3/2007
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test item was administered to animals fasted for 17 hrs by a single gavage using a stomach tube. The dose volume was 0.5 mL per 100g body weight and the individual volume was calculated from each body weight value obtained before the administration.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- A dose of 2,000 mg/kg was administered to three females, this is followed by observation within 30 minutes, once each at 1, 2, 3, 4, 5 & 6 hours after dosing. From the next day after dosing (from day 1 – 7), the animals were observed once daily.
- Statistics:
- No statistical analysis was conducted
Results and discussion
- Preliminary study:
- No preliminary study conducted.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No adverse effects observed
- Mortality:
- No deaths reported
- Clinical signs:
- other: No effects observed
- Gross pathology:
- No grossly visible abnormalities were observed in any animal at 2,000 mg/kg.
- Other findings:
- None
Any other information on results incl. tables
Table 2. Results and observations after dosing
Dose level (mg/kg) 2000 |
Animal I.D No. |
Body weight (g) days after dosing |
Anatomical Finding (days after dosing) |
Mortality (days after dosing) |
Clinical Observation (days after dosing) |
|
0* |
7 |
7 |
7 |
7 |
||
1 |
103 |
137 |
No abnormality observed |
None observed |
None observed |
|
2 |
105 |
136 |
No abnormality observed |
None observed |
None observed |
|
3 |
107 |
128 |
No abnormality observed |
None observed |
None observed |
*Just before administration
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System Unclassified).
- Executive summary:
Methodology similar to OECD 423 (2001) - In an acute oral toxicity study, three group of female Wistar rats (5 -6 week old) were given a single oral dose of the test item using a gavage at dose rate of 2000 mg/kg bw followed by 7 days observation.
No mortality was noted during the observation period, no effects on body weight and no overt toxicological changes were noted. The oral LD50 was estimated to be greater than 2000 mg/kg bw.
In conclusion, the test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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