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EC number: 274-569-0 | CAS number: 70321-85-6
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October - December 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nossan S.r.I., Correzzana (M!), Italy
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 300-350 g
- Housing: housed in groups of up to 5 animals in stainless steel cages
- Diet (e.g. ad libitum): commercially available laboratory diet (Altromin MSK, A. Rieper S.p.A., Bolzano, Italy)
- Water (e.g. ad libitum): tap water
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): fluorescent light to give an artificial cycle of 12 hours light / 12 hours dark - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - intradermal induction: 10% in water
- epidermal induction: 75% in water
- challenge: 20% in water - Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- - intradermal induction: 10% in water
- epidermal induction: 75% in water
- challenge: 20% in water - No. of animals per dose:
- - 10 ainmals in test group
- 5 animals in control group - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
- Positive control results:
- CONTROL SUBSTANCE:
- Mercaptobenzothiazole
RESULTS:
100% positive response in test group and 0% response in control group at challenge - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% in water
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- one animal died during the study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% in water. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one animal died during the study.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20% in water
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- one animal died during the study
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% in water. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one animal died during the study.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20% in water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20% in water. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20% in water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20% in water. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item does not elicit a sensitisation response in the guinea pig.
- Executive summary:
The purpose of the study was to assess the ability of the test substance to cause delayed dermal sensitisation by use of a guinea pig model (Magnusson & Kligman test), following OECD testing method no. 406. 15 animals were used (10 test animals and five control animals). Water was used as vehcile. Applied test item concentrations were 10% for intradermal and 75% for epidermal induction, whereas a 20% solution was used for epidermal exposure in the challenge phase. One animal died during the test. The results obtained in this study indicate that the test substance does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge that could not be clearly attributed to irritation.
Reference
CLINICAL SIGNS:
No clincial signs noted.
MORTALITY:
One animal died during the study.
NECROPSY:
The abdominal cavity ontained a brown fluid material; thoracic cavity contained a red fluid material.
BODY WEIGHTS:
Changes in body weight of surviving animals during the period of the study were generally similar in animals from both test and control groups.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Source: GLP-report
Migrated from Short description of key information:
The potential of the test substance to induce and elicit delayed dermal sensitisation was assessed by a guinea pig model using the maximisation test of Magnusson and Kligman. These results indicate that the test item does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge that could not be clearly attributed to irritation.
Justification for selection of skin sensitisation endpoint:
GLP Klimisch 1 study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available the substance is not classified according to Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).
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