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EC number: 629-664-5 | CAS number: 79710-86-4
- 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:
- 1997-10-27 to 1997-10-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- , adopted 1981
- Deviations:
- yes
- Remarks:
- induction step via injection in the footpad
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: Crl:(HA)BR VAF/Plus
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI
- Age at study initiation: for primary irritation portion: 8 - 9 weeks, for induction and challenge: 4 to 5 weeks
- Weight at study initiation: 304 to 353 g
- Housing: singly, stainless-steel, wire mesh cages
- Diet: PMI Certified Guinea Pig Diet (5026) was available ad libitum
- Water: Public drinking water, regulary asessed, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-22 °C
- Humidity: 52-53 %
- Photoperiod: 12 hours of artificial light - Route:
- other: injected in the footpad
- Vehicle:
- other: acetone, dioxane, and guinea pig fat (7 :2: 1)
- Concentration / amount:
- Induction - 1 % v/v in Freunds Complete Adjuvant (FCA)
Challenge - 10 % v/v in vehicle - Route:
- epicutaneous, open
- Vehicle:
- other: acetone, dioxane, and guinea pig fat (7 :2: 1)
- Concentration / amount:
- Induction - 1 % v/v in Freunds Complete Adjuvant (FCA)
Challenge - 10 % v/v in vehicle - No. of animals per dose:
- 3 male animals for the irritation study
10 male animals for the induction and challenge study
10 male animals for the control group - Details on study design:
- Preliminary :
Animals that were previously exposed to FCA were tested for primary skin irritation. Hair was removed from the backs of the animals with an electric clipper and 0.3 mL of a 10% solution of the test compound in the vehicle was applied to the clipped area. Twenty-four hours later, the animals were depilated and scored for edema and erythema. The skin reaction was also scored at 48 hours. The highest average score for either day determined the concentration to be used in the challenge dose of the main study. The challenge dose was based on the highest concentration of the test substance (up to 10%) that produced no irritation for any of the three animals of a dose group in the primary irritation screen.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 footpad injection per animal
- Test groups: 10 male animals
- Control group: 10 male animlas receiving FCA
- Site: Footpad
- Frequency of applications: one
- Duration: 7 day waitng period until start of challenge
- Concentrations: 1 % v/v in Freunds Complete Adjuvant (FCA)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: 7 days after the final induction
- Test groups: 10 male animals
- Control group: 10 male animals
- Site: dorsal region
- Concentrations: 10 v/v in vehicle
- Evaluation: 24 and 48 after challenge - Challenge controls:
- The control animals were induced with 0.05 mL FCA only and challenged in the same way as test groups.
- Positive control substance(s):
- not required
- Positive control results:
- Not applicable
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Reference
Degree and Nature of lrritation in the prelimiary study
In the primary irritation screen no signs of irritation were noted. In the sensitization study, no dermal responses were noted for the ten animals previously induced with FCA (control animals) or for the ten animals previously induced with 1% of the test substance in FCA (test animals). Based on these results, the test animals were graded as having no sensitization response to the test substance after the challenge application.
Sensitization
No sensitization reactions were observed. All respective erytheme and edema were 0.
Toxic effect other than irritation
No toxic effects or systemic clinical signs were noted during the study.
Body Weights
All animals gained weight during the study
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A dermal sensitization study was conducted acording to OECD 406 with this test substance in guinea pigs using the footpad method. In a primary irritation screen, three animals were administered 10% of the test substance in a vehicle of acetone, dioxane, and guinea pig fat (7:2:1) topically. No signs of irritation were noted at 24 or 48 hours after administration of the test substance; therefore, the concentration used in the challenge dose of the sensitization study was set at 10% of the test substance in the vehicle. In the sensitization study, no dermal responses were noted for the ten animals previously induced with Freund's Complete Adjuvant (FCA) (control animals) or for the ten animals previously induced with 1% of the test substance in FCA (test animals). All animals in both groups were graded as having no response to the test substance after the challenge application. Based on these results, the test substance was not considered to be a dermal sensitizer in guinea pigs. The Iack of any respons at challenge indicates that the test substance is not a skin senitiser.
Migrated from Short description of key information:
A dermal sensitization study conducted acording to OECD 406 in guinea pigs indicates that the test substance is not a skin senitiser.
Justification for selection of skin sensitisation endpoint:
GLP and guideline compliant study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data the test item has no sensitisation potential and was thus not classified and labelled according to Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC (DSD).
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