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EC number: 619-946-6 | CAS number: 890707-29-6
- 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:
- supporting study
- Study period:
- 16.04.2009 - 29.04.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2-Amino-5-cyano-N,3-dimethylbenzamide
- Cas Number:
- 890707-29-6
- Molecular formula:
- C10H11N3O
- IUPAC Name:
- 2-Amino-5-cyano-N,3-dimethylbenzamide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, North Carolina
- Age at study initiation: Approximately 10-11 weeks old
- Weight at study initiation: 196.2–243.1 g
- Fasting period before study: 16-18 hours prior to dosing
- Housing: Animals were housed singly in stainless steel, wire-mesh caging that contained enrichment (e.g., nestlet or nylabone).
- Diet: PMI Nutrition International, LLC Certified Rodent LabDiet (#5002), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 30-70
- Air changes (per hr): Not recorded
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 0.1% Tween-80 in 0.5% aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 20 mL/kg - Doses:
- 175 or 550 mg/kg bw
- No. of animals per sex per dose:
- 3 female rats per dose
- Control animals:
- no
- Details on study design:
- A single oral dose of the test substance, suspended in 0.1% Tween-80 in 0.5% MC, was administered by intragastric intubation to fasted female rats at a dose of 175 or 550 mg/kg bw. The animals were dosed one at a time at a minimum of 48-hour intervals. The animals were observed for clinical signs just before dosing, once during the first 30 minutes after dosing and 2 more times within 4 hours after dosing, and once each day thereafter. The animals were weighed on test Days -1, 0, 7, and 14. All animals were euthanised and necropsied to detect grossly observable evidence of organ or tissue damage.
- Statistics:
- A software package (A0T425StatPgm) was used to determine the dose progression and to calculate the LD50.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 310 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Death occurred in all 3 rats dosed at 550 mg/kg.
- Clinical signs:
- other:
- Body weight:
- lower than 10% body weight loss
- Remarks:
- There were no body weight effects noted.
- Gross pathology:
- No test substance-related gross lesions were found in the study. Gross lesions observed were nonspecific and occurred in low (mostly single) incidences and/or are common findings in rats of this strain and age.
Any other information on results incl. tables
Table 1: Acute oral toxicity of IN-L8E22: Dose progression and mortality
Test sequence | Animal ID | Dose (mg/kg bw) | Short-term result | Long-term result |
1 | 1644 | 175 | O | O |
2 | 1650 | 550 | X | X |
3 | 1654 | 175 | O | O |
4 | 1700 | 550 | X | X |
5 | 1720 | 175 | O | O |
6 | 1722 | 550 | X | X |
(X = Died, O = Survived)
Dose Recommendation: The main test is complete.
Stopping criteria met: 5 reversals in 6 tests. Likelihood Ratio criterion.
Table 2: Acute oral toxicity of IN-L8E22: Summary of long term results
Dose | O | X | Total |
175 | 3 | 0 | 3 |
550 | 0 | 3 | 3 |
All doses | 3 | 3 | 6 |
(X = Died, O = Survived)
Statistical Estimate based on long term outcomes: The LD50 was 310 mg/kg (based on an assumed sigma of 0.5). Approximate 95% confidence interval is 175 to 550 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the estimated oral LD50 for the test substance was 310 mg/kg for female rats.
According to the Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, the test substance is classified in Category 4. - Executive summary:
The acute oral toxicity of the test substance was investigated acoording to the OECD Guideline 425 (Up-and-down procedure).
A single dose of the test substance was administered by oral gavage to 6 fasted female rats at a dose of 175 or 550 mg/kg. The rats were dosed one at a time at a minimum of 48 hour intervals. The rats were observed for mortality, body weight effects, and clinical signs for up to 14 days after dosing. All rats were necropsied to detect grossly observable evidence of organ or tissue damage.
The 3 rats dosed at 550 mg/kg were found dead 1 or 2 days after dosing. Clinical signs observed in 2 of the 3 rats dosed at 550 mg/kg included cold to touch; clear ocular discharge; eyelid ptosis; absent, decreased, or black feces; lethargy; prostrate, low, or high posture; erratic breathing; salivation; stained skin/fur; or bright yellow urine. No clinical signs were observed in the remaining rat dosed at 550 mg/kg. Two of the 3 rats dosed at 175 mg/kg exhibited clinical signs including eyelid ptosis, lethargy, stained skin/fur, chromodacryorrhea, or high posture. No clinical signs were observed after test day 2. The remaining rat dosed at 175 mg/kg exhibited no clinical signs during the study. The surviving rats exhibited no body weight losses. No test substance-related gross lesions were found in the study.Under the conditions of this study, the estimated oral LD50 for the test substance was 310 mg/kg for female rats.
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