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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 09 June 1987 and 10 July 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 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Pamplefleur
- IUPAC Name:
- Pamplefleur
- Test material form:
- other: liquid
- Details on test material:
- Received: 6/04/87
Label: IFF Study 87-209
Storage: The test article was stored at ambient room temperature and humidity.
Description of Test Article: Clear Liquid
Specific Gravity: 0.99
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Following a quarantine period of at least 5 days, five healthy male and five healthy female Wistar Albino rats/group were randomly selected using a computer program of statistics, which generated random numbers. The animals were received from Ace Animals on 5/19, 5/26, 6/09 and 6/16/87.
The pretest weight range was 207-298 g for males and 205-266 g for females.
The weight variation of the animals used did not exceed +/- 20% of the mean weight.
Animals were identified by cage notation and indelible body marks.
The animals were housed 5/sex/cage in suspended wire mesh cages. Bedding was placed beneath the cages. Fresh Purina Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing. Water was freely available at all times.
The animal room, reserved exclusively for rats on acute tests, had a 12 hour bight/dark cycle and was kept clean and vermin free. The temperature range was 18 to 23°C except for a one hour period, at which time the temperature dropped to 16 C. The relative humidity ranged.from 40 to 85%.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Sample Preparation: Used as received
The test article was administered orally, one time, by syringe and dosing needle at a dose level of 5.0 g/kg. Since compound related mortality occurred, additional dose levels were tested. For liquid materials, the dose was based on the sample weight as calculated from the specific gravity. The maximum volume of liquid administered at one time did not exceed 2.0 ml/100 g of body weight if the vehicle was water; or 1. 0 ml/100 g of body weight for vehicle other than water. - Doses:
- The dose schedule follows:
GROUP DOSE, g/kg
Test article 2.6
3.2
4. 0
5. 0 - No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- EXPERIMENTAL DESIGN
The test article was administered orally, one time, by syringe and dosing needle at a dose level of 5.0 g/kg. Since compound related mortality occurred, additional dose levels were tested. For liquid materials, the dose was based on the sample weight as calculated from the specific gravity. The maximum volume of liquid administered at one time did not exceed 2.0 ml/100 g of body weight if the vehicle was water; or 1. 0 ml/100 g of body weight for vehicle other than water. The dose schedule follows:
G ROUP DOSE g/kg
Test article 2.6
3.2
4. 0
5. 0
TYPE AND FREQUENCY 0F OBSERVATIONS
In Vivo
Animals were observed 1, 2 and 4 hours post dose and once each morning and afternoon thereafter for 14 days for mortality, toxicity and pharmacological effects.
Body weights were recorded on the day of dosing, weekly, at death, and at termination in the survivors.
Post Mortem
All animals were examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination. - Statistics:
- The LD50 and 95% Confidence Limits were calculated, if possible, by the method of Litchfield J.T. Jr., & F. Wilcoxon JPE T 96:99, 1949 or Horn H.J.B iometrics 12:311, 1956.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 400 - < 3 800
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 400 - < 4 800
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 100 - < 4 200
- Mortality:
- Mortality response to the four dose levels was as follows:
Dose #Treated #Dead
g/kg M / F M / F
5.0 5 / 5 4 / 4
2.6 5 / 5 0 / 2
3.2 5 / 5 1 / 4
4.0 5 / 5 3 / 4 - Clinical signs:
- other: The deaths occurred by day 2 and were preceded by physical signs of lethargy, ataxia, ptosis, prostrati on, negative righting reflex, diarrhea, flaccid muscle tone, brown staining of body areas and wetness of the nose/mouth and anogenital areas. Physical
- Gross pathology:
- Necropsy of the deaths revealed abnormalities of the lungs, liver, spleen, kidneys and gastrointestinal tract, as well as brown staining of the nose/mouth area and wetness or brown staining of the anogenital area.
Necropsy results of survivors were normal.
Any other information on results incl. tables
LD50
Males : 4.0 (3.4 - 4.8) g/kg
Females : 3.0 (2.4 - 3.8) g/kg
Male and Females combined: 3.6 (3.1 - 4.2) g/kg
Applicant's summary and conclusion
- Interpretation of results:
- other: LD50 - Males: 4.0 (3.4 - 4.8) g/kg Females: 3.0 (2.4 - 3.8) g/kg Male and Females combined: 3.6 (3.1 - 4.2) g/kg
- Conclusions:
- The LD50 and 95% Confidence Limits are: males - 4. 0 (3.4 - 4.8) g/kg; females - 3. 0 (2.4 - 3.8) g/kg; and males & females combined - 3. 6 (3.1 - 4.2) g/kg of body weight.
- Executive summary:
Acute toxicity in rats was examined in a study according to OECD 401. Five healthy male and five healthy female Wistar Albino rats were randomly selected and dosed orally with Pamplefleur at 5.0 g/kg of body weight. Since compound related mortality occurred, five healthy male and five healthy female Wistar Albino rats were dosed at 2.6, 3.2 and 4.0 g/kg of body weight. Mortality response to the four dose levels was as follows: at 5.0 g/kg 4/5 males and 4/5 females died, at 4.0 g/kg 3/5 males and 4/5 females dies, at 3.2 g/kg 1/5 males and 4/5 females died and at 2.6 g/kg 0/5 males and 2/5 females died. The deaths occurred by day 2 and were preceded by physical signs of lethargy, ataxia, ptosis, prostration, negative righting reflex, diarrhea, flaccid muscle tone, brown staining of body areas and wetness of the nose/mouth and anogenital areas. Necropsy of the deaths revealed abnormalities of the lungs, liver, spleen, kidneys and gastrointestinal tract, as well as brown staining of the nose/mouth area and wetness or brown staining of the anogenital area. Physical signs noted in survivors included lethargy, ptosis, ataxia, prostration, negative righting reflex, piloerection, diarrhea, chromodacryorrhea, brown staining of body areas and wetness of the anogenital area. Body weight increases and necropsy results of survivors were normal. The LD50 and 95% Confidence Limits are: males - 4. 0 (3.4 - 4.8) g/kg; females - 3. 0 (2.4 - 3.8) g/kg; and males & females combined - 3. 6 (3.1 - 4.2) g/kg of body weight.
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