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EC number: 700-424-2 | CAS number: 6872-10-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well-documented GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: directive 84/449/EEC
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- methyl 1,3,3-trimethyl-2-methylidene-2,3-dihydro-1H-indole-5-carboxylate
- EC Number:
- 700-424-2
- Cas Number:
- 6872-10-2
- Molecular formula:
- C14 H17 N O2
- IUPAC Name:
- methyl 1,3,3-trimethyl-2-methylidene-2,3-dihydro-1H-indole-5-carboxylate
- Details on test material:
- - Name of test material (as cited in study report): Carboxytrimethylbase, roh, feucht
- Lot/batch No.: Pt. 1 H
- Appearance: black powder (solid)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Borchen, Germany
- Strain: Bor: WISW (SPF Cpb)
- Age at study initiation: males approx. 8 and females approx. 10 weeks
- Weight at study initiation: mean weight for males 177 g, mean weight for females 171 g
- Fasting period before study: approx. 16 hours
- Housing: in groups (5 animals per Makrolon type III cage)
- Diet and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 50 +/- 10%
- Air changes (per hr): 10 times
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE: polyethylene glycol 400
- Application volume:10 ml/kg bw
- test substance formulation was prepared immediately before administration - Doses:
- for males: 1000, 2000, 3100, 5000 mg/kg bw
for females: 1000, 2000 mg/kg bw - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: On day of administration several times, thereafter 2 times per day (exception: on week-end once per day)
- Frequncy of weighing: Before administration and after 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50 was determined computer-assisted according to the method of Rosiello (J. Tox. Environ. Health, 3, 1977, 797), modified by Pauluhn (report no. 11835, Bayer AG, 1983). This procedure is based on the Maximum-Likelihood-Method according to Bliss (J. Pharm. Pharmacol., 11, 1938, 192).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 168 mg/kg bw
- 95% CL:
- 2 549 - 3 940
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Number of deaths at each dose/number of animals in dose group (time of deaths)
Male rats: 1000 mg/kg 0/5; 2000 mg/kg 1/5 (day 1); 3100 mg/kg 1/5 (day 1); 4000 mg/kg 4/5 (day 1); 5000 mg/kg 5/5 (day 1).
Female rats: 1000 mg/kg 0/5; 2000 mg/kg (0/5) - Clinical signs:
- other: Clinical signs occurred approx. 1 hour after administration and were low to medium pronounced. All symptoms were resolved at least on Day 3 after administration. Male rats: - dose groups 2000 to 5000 mg/kg: poor general condition and sedation; dose group
- Gross pathology:
- Gross pathology of the male rats found dead: flattening of gastric mucosa, gastro-intestinal tract partially bloated and reddened or discoloured (violet-orange or violet), lungs strongly reddened, caecum hardened. For one animal of dose group 3100 mg/kg parts of the liver showed pale regions.
All animals sacrificed after the end of the study were found unobtrusive at necropsy.
Applicant's summary and conclusion
- Executive summary:
A rat study according to directive 84/449/EEC (fulfilling OECD TG 401) was conducted under GLP with 5 animals per dose and with dose groups 1000, 2000, 3100 and 5000 mg/kg for males and 1000 and 2000 mg/kg for females.
Clinical signs (poor general condition, sedation, piloerection; for male rats also: increased diuresis, tremor, abdominal position, bloody snouts and eye surroundings; for one male clonical cramps) occurred approx. 1 hour after administration and were low to medium pronounced. All symptoms were resolved at least on Day 3 after administration. No clinical signs were observed for males or females of dose group 1000 mg/kg. Body weight gain was marginally reduced in the 1st and 2nd week post administration for females of dose group 2000 mg/kg. At necropsy the most prominent effects for rats found dead (only males) were observed in the gastro-intestinal tract (flattening of gastric mucosa, gastro-intestinal tract partially bloated and reddened or discoloured, caecum hardened). Also effects on lungs and for one animal on the liver were observed. Gross pathology was unobtrusive for all animals sacrificed at the end of the postobservation period.
The LC50 was 3168 mg/kg for male rats and > 2000 mg/kg for female rats.
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