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EC number: 402-770-7 | CAS number: 92585-24-5 PAMPLEFLEUR
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Auqust 1987 and 18 September 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with OECD guidelines and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Pamplefleur
- IUPAC Name:
- Pamplefleur
- Test material form:
- other: clear liquid
- Details on test material:
- Identity: Pamplefleur.
Chemical name (IUPAC): l-pentanol, 2-methyl-4-phenyl.
Purity: >99%
Description: Clear liquid.
Storaqe: Room temperature in the dark.
Solubility: Insoluble in water.
Emulsions of Pamplefleur was prepared in aqueous 1% methylcellulose (obtained from British Celanese Ltd.) at the concentrations shown overleaf usinq a Silverson hiqh-speed mixer.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- All animals in this study were Specific Pathogen Free CD-1 outbred mice of Swiss origin weighing between 22 and 24 grams and approximately 35 days old, on despatch. The animals were obtained from Charles River U.K. Limited, Marqate, Kent, England on 21st Auqust 1987, 28th Auqust 1987 (preliminary to phases 1 and 2) and 4 September 1987 (main micronucleus test). On arrival, the weight of the animals was checked, the animals were randomly assigned to groups, and tail marked. Each group of 2 or 5 mice was kept in a plastic disposable cage and maintained in a controlled environment with 30 changes of air per hour and the thermostat set at 22degC. The room was illuminated by artificial light for 12 hours per day. All animals were allowed free access to pelleted Labsure LAD 1 rodent breedinq diet and tap water. They were acclimatised for approximately four days, examined daily for signs of reaction and were weighed prior to dosing.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Aqueous 1% methylcellulose (obtained from British Celanese Ltd.)
- Details on exposure:
- From the results obtained in the preliminary toxicity study, a dosage of 871 mq per kg bodyweiqht was chosen for the micronucleus test. Forty male and forty female mice were used in this part of the study.
- Duration of treatment / exposure:
- Followinq dosing the animals were examined reqularly, and any mortalities or clinical signs of reaction to the test compounds were recorded. Five males and five females from the negative control and test compound groups were sacrificed 24, 48 and 72 hours after dosing. The positive control group was sacrificed 24 hours after dosing.
- Frequency of treatment:
- Once only.
- Post exposure period:
- 24, 48 or 72 hours.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Indicate the dose or concentration levels applied and the basis of quantity used.
Basis:
other: Pamplefleur was formulated at 43.55 mg/ml and dosed at 10 ml/kg to give 871 mg/kg.
- No. of animals per sex per dose:
- Thirty-two male and thirty-two female mice were used in the preliminary toxicity test.
Forty male and forty female mice were used in the micronucleus test. - Control animals:
- other: Five males and five females from the negative control groups were sacrificed 24, 48 and 72 hours after dosing.
- Positive control(s):
- Mitomycin C, obtained from Siqma London Chemical Company Limited (batch number 96F-0547-1), was used as the positive control compound. It was prepared as a solution in sterile 0.9% saline at a concentration of 0.6 mq/ml.
Examinations
- Tissues and cell types examined:
- Bone marrow, polychromatic and normochromatic erythrocytes.
- Details of tissue and slide preparation:
- The animals were killed by cervical dislocation and both femurs dissected out from each animal. The femurs were cleared of tissue and one epiphysis removed from each bone.· A direct bone marrow smear was made onto a slide containing a drop of calf serum. One smear was made from each femur. The prepared smears were air-dried and fixed in methanol.
After fixation, the smears were air-dried and stained in Giemsa. After rinsinq in buffered distilled water (pH.6. 8), the slides were air-dried and mounted with coverslips using DPX.
The stained smears were examined (under code) by light microscopy to determine the incidence of micronucleated cells per 1000 polychromatic erythrocytes per animal. The ratio of polychromatic to normochromatic erythrocytes for each animal was assessed by examination of at least1000 erythrocytes. A record of the number of micronucleated normochromatic erythrocytes was also kept as recommended by Schmid. - Evaluation criteria:
- Evaluated for statistically significant increases in micronuleated erythrocytes.
- Statistics:
- Wilcoxon's sum of ranks test was used.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Clinical signs observed.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Preliminary toxicity test
From the results of the preliminary toxicity test, a dosage value of 871 mg/kg was calculated using probit analysis. This dosage was chosen for use in the main test.
Micronucleus test
Signs and mortalities
No animals died in the main study.
Micronucleated polychromatic erythrocyte counts (mnp)
Pamplefleur did not cause any statistically significant increases in the number of micronucleated polychromatic erythrocytes at any of the three kill times - P>O.O5 using Wilcoxon's sum of ranks test.
Micronucleated normochromatic erythrocytes (mnn)
Pamplefleur did not cause any substantial increases in the incidence of micronucleated normochromatic erythrocytes at any of the three kill times.
Ratio of polychromatic to normochromatic erythrocytes (p/n)
Pamplefleur failed to cause any significant decreases in the ratio of polychromatic to normochromatic erythrocytes P>O.O5 using Wilcoxon's sum of ranks test. Mitomycin C caused statistically significant decreases in the ratio (P<0.01).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
From the results obtained it is concluded that Pamplefleur shows no evidence of mutagenic potential or bone marrow cell toxicity when administered orally in this in vivo test procedure. - Executive summary:
An in vivo micronucleus test was performed according to OECD TG 474. In this assessment of the effect of Pamplefleur on the incidence of micronucleated polychromatic erythrocytes in mice, a dosage of 871 mq/kg bodyweiqht was administered orally, by lntraqastric gavage. (A preliminary toxicity test had been carried out to determine the toxicity of Pamplefleur and this dosage was approximately the expected LD10/3d).
Negative and positive control groups were dosed in an identical manner, orally by intragastric gavage. The negative control group received the vehicle, 1% methylcellulose. The positive control group was treated with mitomycin C, at 12 mg/kg.
Bone marrow smears were obtained from the negative control and test compound qroups at 3 sampling times, these being 24, 48 or 72 hours after dosing. Bone marrow smears were obtained from the positive control group 24 hours after dosing. One smear from each animal was examined for the presence of micronuclei in 1000 polychromatic erythrocytes. The ratio of polychromatic to normochromatic erythrocytes was assessed by examination of at least 1000 erythrocytes from each animal. A record of the incidence of micronucleated normochromatic erythrocytes was also kept.
At all sampling times, mice treated with Pamplefleur showed no significant increase in the frequency of micronucleated polychromatic erythrocytes.
There was no siqnificant decrease in the ratio of polychromatic to normochromatic erythrocytes after treatment of the animals with Pamplefleur.
The positive control compound, mitomycin C, produced large, highly significant increases in the frequency of micronucleated polychromatic erythrocytes together with decreases in the ratio of polychromatic to normochromatic erythrocyte.
It is concluded from the results obtained that Pamplefleur shows no evidence of mutagenic potential or bone marrow cell toxicity when administered orally in this in vivo test procedure.
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