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EC number: 265-409-0 | CAS number: 65104-06-5
- 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
In vivo sensitisation study (Tyzor LA): not sensitizer
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- In vitro study not performed since in vivo study available.
- Type of information:
- experimental study
- Remarks:
- In vitro study not performed since in vivo study available.
- Adequacy of study:
- key study
- Study period:
- 1978-10-15-1978-12-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Justification for type of information:
- In vitro study not performed since in vivo study available.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The primary irritation test was conducted on ten unexposed guinea pigs by applying and lightly rubbing in 0.05 mlof a 25% solution of the test material in water on shaved intact shoulder skin.
The induction phase for sensitisation was a series of four sacral intradermal injections of 0.1 ml of a 1.0% solution in physiological saline, one each week, beginning two days after the test for primary irritation.
After a 13-day rest period, the test animals were challenged for sensitization by applying and lightly rubbing in 0.05 ml of a 25% solution of test material in water on shaved, intact shoulder skin. At the same time ten unexposed guinea pigs (controls) received indentical topical applications. - GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- In vitro study not performed since in vivo study available.
- Specific details on test material used for the study:
- 25% test material in water
- Species:
- guinea pig
- Strain:
- not specified
- Remarks:
- albino
- Sex:
- male
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 ml of 1% solution
- Day(s)/duration:
- A week
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, open
- Vehicle:
- water
- Concentration / amount:
- 0.05 ml of and 2.5% and 25% test material
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Ten
- Details on study design:
- The starting point was the information that the test item is moderately skin irritating at 25% solution. The primary irritation was performed at 25% solution of test item on shaved intact shoulder skin. The induction phase for sensitization was a series of four sacral intradermal injections of 0.1ml of a 1.0% solution in physiological saline, one each week, beginning two days after the test for primary irritation. After a 13-day rest period, the test animals were challenged for sensitization by applying and lightly rubbing in 0.05 ml of 25% test material in water on shaved, intact shoulder skin. At the same time ten unexposed guinea pigs (controls) received topical applications.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 0.05 ml 25% test item
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Primary irritation
- Remarks:
- after 24 h
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 0.05 ml of 25% tet item
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Primary irritation test
- Remarks:
- after 48 h
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05 ml of 25% test material
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Mild erythema observed in 2 animals
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05 ml of 25% test item
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Mild erythema observed in one animal
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05 ml of 25% test item
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Mild erythema observed in three animals
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05 ml of 25% test item
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Mild erythema observed in two animals
- Key result
- Reading:
- other:
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No sensitization observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The starting point was the information that the test item is moderately skin irritating at 25% solution. The primary irritation was performed at 25% solution of test item on shaved intact shoulder skin. The induction phase for sensitization was a series of four sacral intradermal injections of 0.1ml of a 1.0% solution in physiological saline, one each week, beginning two days after the test por primary irritation. After a 13-day rest period, the test animals were challenged for sensitization by applying and lightly rubbing in 0.05 ml of 25% test material in water on shaved, intact shoulder skin. At the same time ten unexposed guinea pigs (controls) received topical applications.
No significant score increase at challenge over the response on the concurrent controls was observed.
Justification for classification or non-classification
Based on the results of in vivo study the substance has no potential to cause sensitisation. No classification is required according to the criteria of CLP regulation 1272/2008.
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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