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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
Endpoint summary
Administrative data
Description of key information
CLP: not classified
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Justification for type of information:
- The in vivo test is performed according to Novartis internal Tiered Testing Strategy as a regular set of tests for all substances during the development of the project. (TRD Development Manual Chapter C.26 requirements.)
The Novartis Pharma Data Set (NPDS) has been put in place many years before the REACh regulatio n was released and we have, since then, systematically acquired data for all substances (RM, IM, DS, reagents, etc.) on behalf of TRD and PCS, for internal and external classification purposes. - Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20.6.-14.7.1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The maximisation test has been selected, because it is one of the recommended tests in the OECD guideline 406, adopted May 12, 1981, adapted July 17, 1992, as well as in Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992), and because the ~ensitivity of the method is
well known. The test has been performed in essence according to the original protocol of Magnusson and Kligman (J. invest. Dermatol. 52, 268-276, 1969; Contact Dermatitis 6, 46-50, 1980) . - Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif:DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The test was performed on a total of 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively, initially weighing between 323 to 399 g.
The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperature of 22+3°c, at a relative humidity of 30 to 70% and a 12 hours
light cycle day.
The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG and fresh water. All batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer. Analytical results are available at the animal supply office.
The drinking water quality fulfilled the critical pa.rameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). The results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepa.rtement des Kantons
Aargau, Abteilung Gewaesserschutz) are available to CIBA-GEIGY Limited, as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceutical Division, CIBA-GEIGY Limited. - Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal induction: Oleum arachidis; epidermal induction and challenge: vaseline
- Concentration / amount:
- Intradermal induction: 5% in Oleum arachidis (w/v)
Epidermal induction and challenge: 50 and 30% in vaseline, respectively - Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal induction: Oleum arachidis; epidermal induction and challenge: vaseline
- Concentration / amount:
- Intradermal induction: 5% in Oleum arachidis (w/v)
Epidermal induction and challenge: 50 and 30% in vaseline, respectively - No. of animals per dose:
- 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group
- Details on study design:
- Intradermal Induction
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. The following concentration of test article has been used for intradermal injection:
5% in Oleum arachidis (w/v).
Since 5% CGP 48933 stufe 9 in Oleum arachidis could be injected and was well tolerated, this concentration was used for the intradermal induction.
Epidermal Applications (induction and challenge)
The concentrations for the epidennal applications were selected on acc·ount of the primary irritation potential of the test article. The following concentrations of CGP 48933 stufe 9 have been examined on separate animals for the determination of the maximum subirritant concentration:
30 and 50% in vaseline.
50% was the highest possible concentration of the test article in vaseline.
Reactions were observed with 50% CGP 48933 stufe 9 in vaseline. - Challenge controls:
- The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate
- Positive control results:
- The positive control substance 2-Mercaptobenzothiazole induced positive reactions in 20/20 animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal: 5% in Oleum arachidis / epidermal: 50% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal: 5% in Oleum arachidis / epidermal: 50% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
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