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EC number: 246-874-9 | CAS number: 25340-17-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Remarks:
- Not specified in report.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted prior to the LLNA guidelines
Test material
- Reference substance name:
- Diethylbenzene
- EC Number:
- 246-874-9
- EC Name:
- Diethylbenzene
- Cas Number:
- 25340-17-4
- Molecular formula:
- C10H14
- IUPAC Name:
- diethylbenzene
- Details on test material:
- Polyethylbenzene coded MF335
Ethanol (100%) Lot D2-72331 was received from Gold Shield Company, Hayward, CA.
Nanograde acetone, Lot 10212 was received from VWR Scientific, Inc., San Francisco, CA
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Female Hartley albino guinea pig, CEHC Lot# 63, were obtained from Charles River Breeding Laboratory , Portage, Michigan. The guinea pigs were allowed a one week quarantine followed by a 22 day acclimation period. The animals weighed 395-498 grams and were nine weeks old on the first day of dosing. All animals were weighed on Day 0 and on the last day of scoring for challenge. Animals were housed individually in stainless steel wire-bottom cages in a temperature-regulated room. In the study room, the temperature ranged from 20-22C and the relative humidity from 40-59%. The photoperiod was a 12-hour light/dark cycle. The animals had unlimited access to Purina Certified Guinea Pig Chow #5026 and water except during the test material exposure period.
Selection and Identification of Animals
Animals were randomly assigned to treatment groups using the WTALOC program of the DATATOX System (INSTEM Computer Systems Plc., Stone, Staffordshire, England). There were no signifcant differences in mean body weights between groups of animals at the beginning of the study. All animals were identified by a numerically coded ear punch and by a color-coded cage card that stated the animal number, sex, study number, test material name and code number, dosage and date of treatment.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol or acetone
- Concentration / amount:
- Induction: 10% PEB (w/w in ethanol); Challenge: 5% PEB (w/w in acetone)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol or acetone
- Concentration / amount:
- Induction: 10% PEB (w/w in ethanol); Challenge: 5% PEB (w/w in acetone)
- No. of animals per dose:
- PEB (20) Induction: 10% PEB (w/w in ethanol); Challenge: 5% PEB (w/w in acetone)
Irritation Control (10) Induction: 100% ethanol; Challenge:5% PEB (w/w in acetone)
Vehicle Irritation Control (5) Induction: 100% ethanol; Challenge:100% acetone - Details on study design:
- Induction
Over a 15-day period, three occluded epicutaneous applications were administered on Wednesdays. The left flank of each animal was clipped the day before each induction application. All dosing solutions were administered with a manual pipettor. A Hill Top Chamber containing 0.3 ml of the dosing mixture was applied to the left flank of each animal. The chambers were occluded by a rubber dental dam pulled taut and fastened to the bottom of the restrainer with clips. After approximately six hours the dental dam and chamber were removed, the animals was taken from the restrainer and returned to its cage.
Challenge Treatment
The animals were challenged 14 days after the third induction application. The right flank of each animal was clipped free from fur on the day before dosing. A Hill Top Chamber containing 0.3 ml of the dosing mixture was applied to the right flank of each animal and wrapped as described above. After approximately six hours the dental dam and chamber were removed, the animals was taken from the restrainer and returned to its cage. Approximately 24 hours after the beginning of the challenge exposure, the test sites and surrounding areas were depilated with a lotion hair remover. The depilatory was washed off thoroughly with warm tap water, and the animals were dried and returned to their cages. Skin scorings were conducted at 24 and 48 hours after unwrapping, and at least 2 hours after depilation, using the system described by Buehler. Edema was noted but not scored.
Assessment of Skin Irritation and Sensitization Potential
In order to assess the skin sensitization potential of Polyethylbenzene, the skin irritation scores of test animals and their corresponding irritation controls were compared. An animal induced with the test material was considered to be sensitized of its challenge irritation scores were greater and/or more persistent than scores for animals in the corresponding irritation control group following a first exposure to the test material.
Experimental Design:
One group of 20 female Hartley albino guinea pigs was induced with 10% Polyethylbenzene weight/weight (w/w) in ethanol and challenged with 5%
Polyethylbenzene (PEB) (w/w) in acetone. Additional groups of 10 and 5 female guinea pigs served as concurrent irritation controls for the
Polyethylbenzene and vehicle, respectively. Dosing mixtures were sampled for homogeneity and stability after dose preparation for the first induction application and concentration analysis of the 5% Polyethylbenzene w/w in acetone and 100% acetone.
No. of Animals
PEB (20) Induction: 10% PEB (w/w in ethanol); Challenge: 5% PEB (w/w in acetone)
Irritation Control (10) Induction: 100% ethanol; Challenge:5% PEB (w/w in acetone)
Vehicle Irritation Control (5) Induction: 100% ethanol; Challenge:100% acetone
Clinical observations:
Each animal was observed once daily for physiological or behavioral abnormalities, overt signs of toxicity and a viability check.
Statistical Analysis:
Body weights were statistically analyzed - Challenge controls:
- Irritation Control (10 animals): Induction: 100% ethanol; Challenge:5% PEB (w/w in acetone)
Vehicle Irritation Control (5) Induction: 100% ethanol; Challenge:100% acetone - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- other: readings after 24 and 48 hours
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100% ethanol induction and 5% w/w in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other:
- Remarks:
- No sensitization responses were observed. Dermal responses observed within each test group were equivalent. With the exception of 3 animals, no to slight, patchy erythema was observed in all groups at 24 and 48 hours after challenge. Slight patchy erythema to slight, but confluent or moderate, patchy eythema was observed in one vehicle control and two test material-induced animals 24-48 hours after challenge
- Reading:
- other: readings after 24 and 48 hours
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% ethanol induction and 100% acetone challenge
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other:
- Remarks:
- No sensitization responses were observed. Dermal responses observed within each test group were equivalent. With the exception of 3 animals, no to slight, patchy erythema was observed in all groups at 24 and 48 hours after challenge. Slight patchy erythema to slight, but confluent or moderate, patchy eythema was observed in one vehicle control and two test material-induced animals 24-48 hours after challenge
Any other information on results incl. tables
Analytical Results
Homogeneity samples contained 87% of the target concentration with a coefficient of variation of 0.85 for 6
samples. The analysis of the stability samples showed that they contained 101% of the initial concentration.
Concentration check samples taken at challenge were found to contain 74% of the target concentration.
Animals were observed for mortality or compound-related signs of toxicity during
the study.
Animal observations
No mortality or compound-related signs of toxicity were observed during the study.
Skin Sensitization
Challenge
No sensitization responses were observed.Dermal responses observed
within each test group were equivalent. With the exception of three
animals,no to slight, patchy erythma was observed in all groups at 24
and 48 hours after challenge. Slight patchy erythema to slight, but
confluent or moderate, patchy erythema was observed in one vehicle
control and two test material-induced animals 24-48 hours after
challenge.
Body Weights
Statistical analysis showed no significant differences for mean body weights or
mean body weight gain between
control and treated animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- No sensitization responses were observed in animals induced with 10% Polyethylbenzene and challenged with 5% Polyethylbenzene. Therefore, Polyethylbenzene is not considered to be a sensitizer.
- Executive summary:
The skin sensitization potential of Polyethylbenzene was evaluated using the procedure described by Buehler. One group of 20 female guinea pigs was induced with 10% Polyethylbenzene weight/weight (w/w) in ethanol and challenged with 5% Polyethylbenzene weight/weight (w/w) in acetone. Additional groups of 10 and 5 female guinea pigs served as concurrent irritation controls for the Polyethylbenzene and vehicle, respectively.
No sensitization responses were observed in animals induced with 10% Polyethylbenzene and challenged with 5% Polyethylbenzene.
Therefore, Polyethylbenzene is not considered to be a sensitizer under the conditions tested.
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