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EC number: 406-080-7 | CAS number: 83016-70-0 JEFFCAT ZF-10; TEXACAT ZF-10
- 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
The test substance was demonstrated to be not sensitising to the skin in a key, reliable Delayed contact hypersensitivity study in guinea pigs.
An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study (initiated before October 2016) is available.
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:
- 1990-04-09 to 1990-05-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study is GLP compliant and equivalent or similar to EU and OECD Guidelines. The highest non-irritating dose was used as opposed to a dose that causes mild to moderate irritation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Annex V (Buehler)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The skin sensitisation potential of the test substance was investigated in an in vivo study in guinea pigs. The study was performed, prior to the date where Local Lymph Node Assay (LLNA) was considered a the default assay.
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 6398-16-20
- Physical state: clear, pale yellow liquid
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration
- Other: The purity, identity, strength and stability of the test article were the responsibility of the sponsor. - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BuckberG Lab Animals, Tomkins Cove, New York
- Weight at study initiation: 300 - 500 g
- Housing: Individually in 1/2" wire mesh cages
- Diet: Purina Guinea Pig DietR, ad libitum
- Water: Fresh tap water, at libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- other:
- Vehicle:
- other: 80% ethanol
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
1% in 80% aqueous ethanol for each of three inductions
Concentration of test material and vehicle used for each challenge:
1% in 80% aqueous ethanol - Route:
- other: dermal
- Vehicle:
- other: 80% ethanol
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
1% in 80% aqueous ethanol for each of three inductions
Concentration of test material and vehicle used for each challenge:
1% in 80% aqueous ethanol - No. of animals per dose:
- Number of animals in dose-range-finding test: 4
Number of animals in test group: 20
Number of animals in negative control group: 10
Number of animals in positive control group: 5 - Details on study design:
- RANGE FINDING TESTS:
Four animals (2 male, 2 female) were each exposed to four different concentrations of the test article to determine the highest non-irritating dose. In this test, both sides of the animal were shaved and exposed to 4 concentrations of the material. The highest non-irritating concentration was that concentration in vehicle that induced responses not exceeding two + and two 0 grades in the group of four animals. Based upon the results of this study and in discussion with the sponsor, the dose chosen for induction and challenge was 1.0%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: Male and female, 1% in 80% ethanol
- Control group: Positive control and vehicle control
- Site: Left shoulder
- Frequency of applications: Once a week
- Duration: 3 weeks
- Concentrations: 1% in 80% enthanol
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction exposure
- Exposure period: 6 hours
- Test groups: Male and female, 1% in 80% ethanol
- Control group: Positive control, vehicle control, and challenge control
- Site: Shoulder on opposite side of induction exposure
- Concentrations: 1% in 80% ethanol
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- The test material was used in the vehicle control animals during the challenge exposure.
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene (DNCB)
- Positive control results:
- A positive response was elicited in the animals receiving the positive control substance.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Severity = 0.1
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 80 % Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Severity = 0.0
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1% 6398-16-20
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Severity = 0.2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3 % DNCB
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Severity = 3.0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Severity = 0.1
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 80 % Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Severity = 0.0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1% 6398-16-20
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Severity = 0.0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3 % DNCB
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Severity =3.0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observations made in this study, the test material induced and challenged at 1% concentration did not cause delayed contact hypersensitivity in guinea pigs.
- 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
Referenceopen allclose all
Maximum concentration not causing irritating effects in preliminary test: 1 %
Signs of irritation during induction: Slight-moderate patchy erythema was seen after each induction dose in 4 -7 animals.
Evidence of sensitisation of each challenge concentration: No evidence of sensitization was observed in test and control animals.
Other observations: All skin reactions noted after challenge were slight patchy erythema.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation in vivo:
A Delayed Contact Hypersensitivity study was performed according to OECD guideline 406. The test material induced and challenged at 1% concentration did not cause delayed contact hypersensitivity in guinea pigs.
Skin sensitisation in vitro:
An in vitro or in chemico skin sensitisation does not need to be conducted because adequate data from an in vivo skin sensitisation study (initiated before October 2016) is available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data and the criteria laid down in the CLP Regulation (EC) 1272/2008, the substance is not to be classified as skin sensitizer.
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