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EC number: 604-047-3 | CAS number: 137863-20-8
- 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:
- June - Aug 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Tetrazolyl-valinesteramid (3-methyl-2-{pentanoyl-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid benzyl ester)
- EC Number:
- 604-047-3
- Cas Number:
- 137863-20-8
- Molecular formula:
- C31 H35 N5 O3
- IUPAC Name:
- Tetrazolyl-valinesteramid (3-methyl-2-{pentanoyl-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid benzyl ester)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAlf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Albino rats, Tif:RAlf (SPF). from CIBA-GEIGY Limited, Animal Production, 4332 Stein, Switzerland were used. Animals were utilized only if they were judged
healthy on the basis of general observations and body weight (performed predose). Animals were assigned to the different groups using computer-generated random numbers. Animal identification was by an individual number written, with a waterproof marker, on the tail.
The animals were acclimatized to laboratory conditions for at least 5 days. The initial age (at dosing) was 6 to 9 weeks. The initial weight range (at dosing) was
226.4 to 273.6 g.
The animals were housed individually, on sterilized softwood particle bedding (manufactured by Scierie des Eplatures, 2300 La Chaux-de-Fonds, Switzerland), in
Macrolon® cages (type III), which were kept in an air-conditioned room. The temperature was 22 ± 3 °c, and the relative humidity 30 to 70 %. Artificial light
was provided from 6 a.m. to 6 p.m.
Pelleted standard diet NAFAG No. 890 was freely available (NAFAG, 9202 Gossau, Switzerland). The diet is analyzed for composition and contaminants by
the manufacturer and analytical results are archived by the Animal Supply Office CIBA-GEIGY.
Tap water was freely available. The water is analyzed periodically by lndustrielle Werke Basel (Basel City water supply plant) for compliance with Swiss drinking
water specifications
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Wetting agent: Sesame oil
- Remarks:
- the test article was only wet with sesame oil and no solution was made
- Details on dermal exposure:
- The test article was administered once, by topical administration under occlusion, for 24 hrs.
The administration was performed between 8:00 a.m. and 10:30 p.m.,- following overnight fasting.
Start dose selected: 2000 mg/kg - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- The aim was to test the accepted limit dose of 2000 mg/kg. This dose was given first to a single female rat and additional animals were treated to complete a group of five male and five female rats.
- Control animals:
- no
- Details on study design:
- The study was conducted according to the OECD guideline No.: 402 (Adopted 24-Feb-87) modified such that clinical signs were used as an endpoint and that animals with severe signs were sacrified.
The rat was selected as a standard rodent species.
The aim was to test the accepted limit dose of 2000 mg/kg. This dose was given first to a single female rat and additional animals were treated to complete a group of five male and five female rats.
The animals were observed for 14 days after dosing to see if there were any latent toxic effects. Necropsy included investigation of major viscera.
Selection of dose levels was based on guidelines.
PBS 859 DS, batch P.Op.1/94, was administered once by topical application under occlusion for 24 hrs.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality was observed.
- Clinical signs:
- No systemic and no local clinical signs were observed.
- Body weight:
- The body weight gain was generally not influenced by the PBS 859 DS treatment. In most of the females, the weight was slightly reduced on day 4 after the occlusive application; the body weight increased again by day 9.
- Gross pathology:
- No macroscopic changes were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of treatment with a limit dose of 2000 mg/kg, no systemic or local effects were observed. PBS 859 DS is, therefore, non-toxic dermally at the limit dose of 2000 mg/kg.
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