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Diss Factsheets
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EC number: 480-310-4 | 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:
- key study
- Study period:
- 29 August 2006 to 15 September 2006 (In Life)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level of relative humidity occured. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviations.
- Qualifier:
- according to guideline
- Guideline:
- other: EC, Council Directive 67/548/EEC, Annex V, B.1 tris (2004) "Acute Oral Toxicity"
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level of relative humidity occured. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviations.
- Qualifier:
- according to guideline
- Guideline:
- other: EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity-Acute Toxic Class Method"
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level of relative humidity occured. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviations.
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000) including the most recent partial revisions
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level of relative humidity occured. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviations.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 6675
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Analytical purity: Formulation tested is 30.0% active ingredient in water
- Purity test date: 12/20/2005
- Lot/batch no.: 140499-8/25
- Expiration date of the lot/batch:02 July 2008
- Storage condition of test material: Refrigerated (2-8 degrees C) in the dark
Test animals
- Species:
- rat
- Strain:
- other: Wistar CRl:WI (outbred, SPF-Quality)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approximately 8 weeks old
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean
- Fasting period before study: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance
- Housing: Group housing of 3 animals per cage in labelled Macrolon cages. Sawdust as bedding and paper as cage-enrichment.
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiaten GmbH, Soest Germany) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days before the start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20.5-23.0 degrees C
- Humidity (%): 30-70%
IN-LIFE DATES: From: 29 August 2006 To: 15 September 2006
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Formulation of MTDID 6675 is 30% of the active ingredient (test material) in water
- Doses:
- -6667 mg/kg (5.747 mL/kg) body weight (2000 mg/kg for the active ingredient)
-1000 mg/kg (0.862 mL/kg) body weight (300 mg/kg for the active ingredient) - No. of animals per sex per dose:
- 3 females at 6667 mg/kg bw (2000 mg/kg bw active ingredient) dose level and 2 groups of 3 females at 1000 mg/kg bw (300 mg/kg active ingredient)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At 0, 2, and 4 hours after dosing on day 1, and once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - 2 000 mg/kg bw
- Mortality:
- 3/3 females in the 2000 mg/kg (active ingredient) group were found dead between days 1 and 2 post-dose. No mortality was observed in either of the 300 mg/kg (active ingredient) groups.
- Clinical signs:
- Hunched posture was noted at both dose levels (300 and 2000 mg/kg active ingredient). Animals in the 2000 mg/kg (active ingredient) group also exhibited uncoordinated movements and piloerection.
- Body weight:
- Animals surviving to necropsy (300 mg/kg active ingredient treatment group) had normal body weiht gains over the 14 day study period.
- Gross pathology:
- In each of the females in the 2000 mg/kg (active ingredient) group isolated dark red foci in the gladular mucosa were found in the stomach.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test, the acute oral LD50 of the test article was between 300 and 2000 mg/kg. According to the Global Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations, the test article should be classified as: harmful if swallowed (Category 4) for acute toxicity by the oral route.
- Executive summary:
he objective of this study was to evaluate the acute oral toxicity of the test article (Batch No. 140499-8/25) in rats according to the OECD 423 (2001) test guideline. Initially, the test article was administered by oral gavage to 3 female Wistar rats at 2000 mg/kg (active ingredient). In a stepwise procedure, additional groups of females were dosed at 300 mg/kg. Clinical signs were recorded daily for 2 weeks. Body weights were measured on days 1 (pre-dose), 8 and 15 post-dose. Necropsies were performed on day 15 post-dose. Three females in the 2000 mg/kg dose group were found dead between days 1 and 2 post-dose. Hunched posture was noted at both dose levels (300 and 2000 mg/kg). Animals in the 2000 mg/kg treatment group exhibited hunched posture, uncoordinated movements, and piloerection. Animals surviving to necropsy (300 mg/kg treatment group) had a normal body weight gains over the 14-day study period. Macroscopic post mortum examination revealed abnormalities in the stomach among the animals that died during the study. No treatment-related abnormalities were found in the surviving animals at termination. Under the conditions of the test, the acute oral LD50 of the test article was between 300 and 2000 mg/kg. According to the Global Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations, the test article should be classified as: harmful if swallowed (Category 4) for acute toxicity by the oral route.
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.
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