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EC number: 604-139-3 | CAS number: 139481-69-9
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Date of start of the experimental period: 27 May 2004 - Date of end of the experimental period: 10 June 2004.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Experimental study is been performed according to guideline (OECD 402).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- methyl 2-ethoxy-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate
- EC Number:
- 604-139-3
- Cas Number:
- 139481-69-9
- Molecular formula:
- C25H22N6O3
- IUPAC Name:
- methyl 2-ethoxy-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate
- Test material form:
- solid: particulate/powder
- Details on test material:
- batch No. February 2004
Constituent 1
- Specific details on test material used for the study:
- On 20 April 2004, one sample of CAN 5, batch No. February 2004, was received. Immediately upon receipt, CAN 5 was registered, then stored at ambient temperature and protected from light in accordance with the Sponsor's instructions. The complete description of the chemical and physical properties of the CAN 5 including stability, is the responsibility of the Sponsor.
Appearance: White powder.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Origin: Charles River Laboratoires France, Domaine cles Oncins, 69592 L'Arbresle Cedex, France.
- Identification: Animals were identified individually by marking the tail with a felt-tip marker.
- Age: 8-12 weeks at the time of administration.
- Number: Limit test: 5 males, 5 females.
- Acclimatization: Minimum of five days before the treatment in the laboratory animal house where
the experiment took place.
- Housing: Daily observations were performed at the time of delivery of the animals and during the
period of acclimatization. Animals were housed in cages of standard dimensions with sawdust bedding
(or equivalent). Cages were cleaned at least once per week.The animals were placed in an air-conditioned (19-23 "C) animal house kept at relative humidity between 45% and 65% in which non-recycled fìltered air was changed approximately 10 times per hour. The artificial day/night cycle involved 12 hours light and 12 hours darkness with light on at 7.30 a.m.
Feeding: RM1 (E)-SQC SDS/DIETEX (quality controlled/radiation sterilised) was available ad libitum. The criteria for acceptable levels of contaminants in the feed supply were within the limits of the analytical specifìcations established by the diet manufacturer.
- Drinking water: Drinking water was available ad libitum in polycarbonate feeder bottles with a stainless steel nipple. A specimen of water is obtained every 6 months and sent to the Laboratoire Départemental d'Analyse du Cher- 216, Rue Louis Mallet- 18014 Bourges Cedex, France, for analysis. The criteria for acceptable levels of contaminants in the water supply were within the limits of the analytical specifìcations.
Administration / exposure
- Type of coverage:
- other: CAN 5 was applied to each animal on a piece of absorbant gauze measuring 30 cm2 (6 cm x 5 cm).
- Vehicle:
- other: CAN 5 was moistened with sterile water in order to ensure good contact with the skin.
- Details on dermal exposure:
- Timing, frequency and duration of administration
CAN 5 was applied to the back of the animal on a previously shaved area. The absorbent gauze was
held in piace for 24 hours using an elastic band. At the end of the exposure period, no remaining CAN
5 was noted.
Application of the test substance
CAN 5 was applied to the skin in the dorsal region of each animal without prior fasting. For this purpose, on the day prior to application, the dorsal region of each rat was carefully clipped on an area of approximately 50 cm2 using an electric clipper, avoiding damage to the skin. Any animal found to have damage skin at the time of application was removed from the study. On the day of study, test substance was applied to the prepared area to expose at least 10% of the total body surface. CAN 5 was applied to each animal on a piece of absorbant gauze measuring 30 cm2 (6 cm x 5 cm). - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Single group often animals (5 males and 5 females) was dosed at the dose of2000 mg/kg body weight.
- Control animals:
- not required
- Details on study design:
- General clinical examination
Animals were examined clinically twice on the day of treatment (between 30 and 90 minutes after administration and then again between 3 and 4 hours post-dose). Thereafter they were examined clinically at least once daily far 14 days.
Full clinical examination
On D1 between 30 and 90 minutes after administration and on 07 the animals were submitted to a full clinical examination outside the housing cage, including functional and neurobehavioural tests.
Examination performed
-Skin lesion evaluation
-Necropsy
-Mortality
-Body weight
Results and discussion
- Preliminary study:
- Dermal application of the test substance CAN 5 (batch No. February 2004) at a dose of 2000 mg/kg caused no mortality and no dermal reactions during a 14-day period, in the male and female Sprague-Dawley rats.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No clinical signs were observed during the course of the study.
- Body weight:
- Mean weight gain in treated animals was normal when compared with values usually found in our Centre.
- Gross pathology:
- No organ or tissue gross findings were seen at necropsy.
- Other findings:
- No dermal reactions were observed during the course of the study.
Any other information on results incl. tables
Body weight and clinical signs are reported in the illustration attached below.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions adopted, dermal application of the test substance CAN 5 (batch No. February 2004) at a dose of 2000 mg/kg caused no mortality and no dermal reactions during a 14-day period, in the male and female Sprague-Dawley rats.
Under the experimental conditions adopted, the LD50 of the test substance CAN 5 (batch No. February 2004) administered by the dermal route was higher than 2000 mg/kg body weight
in the male and female Sprague-Dawley rats. - Executive summary:
Under the experimental conditions adopted, dermal application of the test substance CAN 5 (batch No. February 2004) at a dose of 2000 mg/kg caused no mortality and no dermal reactions during a 14-day period, in the male and female Sprague-Dawley rats.
Under the experimental conditions adopted, the LD50 of the test substance CAN 5 (batch No. February 2004) administered by the dermal route was higher than 2000 mg/kg body weight in the male and female Sprague-Dawley rats.
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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