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EC number: 500-105-6 | CAS number: 39423-51-3 1 - 6.5 moles propoxylated
- 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
Based on the delayed contact hypersensitivity study in guinea pigs according to OECD guideline 406, performed by Pharmakon Research International, Inc. in 1987, it is concluded that the substance is not sensitising to the skin.
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:
- 1987-05 to 1987-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- 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:
- Experiment performed according to the OECD 406 guideline adopted in 1981, which is intended primarily for use with guinea pig.
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: no apparent change in the physical appearance of the test article during administration
OTHER SPECIFICS:
- Name of test material (as cited in study report): 5601-88-1 - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products, Inc., Denver, Pennsylvania
- Weight at study initiation: 300-600g
- Housing: two per cage, wire mesh cages.
- Diet (e.g. ad libitum): Wayne Guinea Pig Diet, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: May 28, 1987 To: June 27, 1987 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% ethanol
- Concentration / amount:
- 0.4ml per site
first induction: 70%
second and third induction: 40%
challenge 40% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% ethanol
- Concentration / amount:
- 0.4ml per site
first induction: 70%
second and third induction: 40%
challenge 40% - No. of animals per dose:
- dose range: 6
test article: 20 (10 male, 10 female)
positive control: 6 (3 male, 3 female)
negative control: 10 (5 male, 5 female)
naive: 4 (2 male, 2 female) - Details on study design:
- 2 RANGE FINDING TESTS:
3 males, 3 females: each animal is exposed to 4 different concentrations of the test material (1%, 10%, 25%, 100%): 80% ethanol as the vehicle.
1 male, 1 female: each animal is exposed to 4 different concentrations of the test material (50%, 60%, 70%, 80%): 80% ethanol as the vehicle
primary challenge responses were graded
Highest non-irritatting concentration = concentration in vehicle that induced responses not exceeding 2 "+" and 2 "0" grades in the group of 4 animals.
the dose chosen for induction: 70%,
the dose chosen for challenge: 40%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4 (3 inductions, 1challenge)
- Exposure period: -
- Test groups: test substance in vehicle (80% ethanol)
- Control group: vehicle only
- Site: L shoulder (first induction); R shoulder (second and third induction)
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 70% (first induction); 40% (second and third induction)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 29
- Exposure period: -
- Test groups: test substance in vehicle
- Control group: vehicle only
- Site: naive site on left flank
- Concentrations: 40%
- Evaluation (hr after challenge): 24 and 48h
OTHER:
24h after challenge, all animals were depilated with Neet Cream Hair Remover (Whitehall Laboratories, Inc., New York). A minimum of 2h after depilation test sites were graded. The grading was repeated 24h later (48h grade). - Challenge controls:
- Four naive animals (2 males, 2 females) were induced with the test material (40% concentration) on challenge day in the same manner as the test group and control groups.
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
- Positive control results:
- Sensitising effects were observed in all six animals of the positive control group.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- severity= 0.1
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- severity= 0.1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- severity= 0.4
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- severity= 0.2
- Key result
- Reading:
- other: naive control
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- severity= 0.0
- Key result
- Reading:
- other: naive control
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- severity= 0.1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- severity= 3.0
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- severity= 3.0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the observations made in the assay, the test article induced at 70% (1st) and 40% (2nd and 3rd) and challenged at a 40% 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:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Only one GLP study conducted in accordance with OECD guideline 406 is available. The study examined the skin sensitising effect on guinea pigs, using 20 animals in total. Positive, solvent and negative controls were included in the study. Animals were induced 3 times with either 70% (1st induction), or 40% (2nd and 3rd induction) the test substance. A challenge was performed using a 40% solution. At both 24 and 48 hours after the challenge none of the animals expressed positive reactions. Furthermore all controls showed expected results, resulting in a valid assay. Based on this study it was concluded that the substance did not cause delayed contact hypersensitivity in guinea pigs and is therefore considered not sensitizing.
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 11th 2016) is available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
- Based on the available information and the criteria of the CLP Regulation, the substance does not need to be classified as a skin sensitizing substance.
- No data are reliable available on respiratory sensitization. Therefore, no conclusion can be made on the classification for this endpoint.
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