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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6.6.1994 - 27.6.1994
- 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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
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:
- rabbit
- Strain:
- other: Chbb:HM (SPF)
- Details on test animals or test system and environmental conditions:
- Rabbits Chbb:HM (SPF) from Dr. K. Thomae GmbH, Biberach (FRG) 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 study using computer-generated random numbers.
Animal identification was by an individual number written with a waterproof marker on the ear.
The animals were acclimatized to laboratory conditions for 7 days. The initial age (at dosing) was 148 to 169 days. The initial weight range (at dosing) was 2309 to
2346 g.
Husbandry
The animals were housed individually in stainless steel cages in an air-conditioned room. The temperature was 20 ± 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. 814 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 (batches are given in the raw data).
Tap water was freely available. The water is analyzed periodically by Industrielle Werke Basel (Basel City water supply plant) for compliance with Swiss drinking
water specifications.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other:
- Controls:
- other: not required, the untreated skin sites of each animal served as control
- Amount / concentration applied:
- Application volume: 0.5 g / animal
Amount of test article applied: 0.5 g / patch - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
reading time points: 1, 24, 48 and 72 h and 7 d - Number of animals:
- 3
- Details on study design:
- The study was conducted according to the OECD guideline 404 (adopted l 7-Jul-92).
The rabbit is one of the recommended species for irritation testing.
The animals were observed for 7 days after dosing to see if there were any latent toxic effects.
Selection of dose levels was based on OECD guideline.
PBS 859 DS, batch P.Op. 1 / 94, was administered topically under occlusion for 4 hours to groups of 3 rabbits (russian) Chbb:HM (SPF)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Spotts of slight erythema reactions were observed in two of 3 animals 24 and 48 hrs. after removing the bandages. In one animal the slight erythema reaction covered the whole application area when assessed 72 hrs. after removing the bandage. At the end of the observation period, scaling was observed in the two animals showing erythema reactions at the beginning of the observation period. No edema formation was observed during the whole observation period.
Any other information on results incl. tables
Mortality: No mortality was observed.
Clinical Signs: No systemic clinical signs were observed
Body Weight: No compound related effect was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
The reactions observed are clearly lower than the criteria defined for the risk phrase of skin irritation of the EEC
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