Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
An acute oral study according to OECD Guideline 401 was conducted at test concentrations up to 5000 mg/kg, the LD50 value was calculated to be 3600 mg/kg.
Acute dermal: In a study performed according to OECD 402 the LD 50 was found to be greater than 2000 mg/kg of body weight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- 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%. - 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.
- 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. - 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 600 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 11 June 1987 and 25 June 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with OECD Guidelines and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Following a quarantine period of at least one week, five healthy male and five healthy female New Zealand Albino rabbits were randomly selected using a computer program of statistics, which generated random numbers. The animals were received from Clifford Roedel on 5/15/87.
The pretest weight range was 2.4 - 2.9 kg for males and 2. 4 - 2.6 kg for females.
The animals were identified by cage notation and a uniquely numbered metal eartag.
The animals were housed 1/cage in suspended wire mesh cages. Bedding was placed beneath the cages. Fresh Purina Rabbit Chow ( Diet #5321) and water were freely available.
The animal room, reserved exclusively for rabbits on acute tests had a 12 hour light/dark cycle and was kept clean and vermin free. The temperature range was 19° to 24°C. The relative humidity ranged from 40 to 85%. - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hours prior to application of the test article, the dorsal area of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact.
The test article was applied to the prepared dermal site, one time, by syringe type applicator on a g/kg basis. - Duration of exposure:
- 24 hours
- Doses:
- 2 g/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- EXPERIMENTAL DESIGN
The test article was applied to the prepared dermal site, one time, by syringe type applicator on a. g/kg basis. For liquid materials, the dose was based on the sample weight as calculated from the specific gravity. For solid materials, the dose was based on the dry weight of the test article and was slightly moistened with water prior to application. The test article was covered with a gauze patch and gentle pressure was applied to the gauze to aid the distribution of the test article over the prepared site. The torso was wrapped with plastic which was secured with nonirritating tape. At 24 hours, the patches were removed and site was washed gently with water or an appropriate solvent, if necessary. The dose schedule follows:
GROUP Dose, g/kg
Test Article 2.0
TYPE AND FREQUENCY 0F OBSERVATIONS
In Vivo
The test sites were scored for dermal irritation at 24 hours post dose and on days 7 and 14 using the numerical Draize scale.
Additional signs were described.
If necessary to evaluate reversibility, observations were extended.
The animals were observed 1, 2 and 4 hours post dose and twice daily for 14 days for mortality, toxicity and pharmacological effects.
Body weights were recorded pretest, weekly, at death and at termination.
Post Mortem
All animals were examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination.
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1 millimetre) 3
Severe edema (raised more than 1 millimetre and extending beyond the area of exposure) 4 - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95% confidence limits not reported.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: Physical signs of diarrhea, yellow nasal discharge, few feces, emaciation, rales and soiling of the anogenital area were noted during the observation period.
- Gross pathology:
- Necropsy results were normal in 7/10 animals. Gastrointestinal tract abnormalities, brown staining of the anogenital area and emaciation were noted in the remaining animals.
- Other findings:
- Dermal reactions, absent to slight on days 1 and 7, were absent on day 14.
- Interpretation of results:
- other: not considered to be toxic
- Remarks:
- Criteria used for interpretation of results: other: less than one-half of the animals died at 2.0 g/kg
- Conclusions:
- The LD50 is greater than 2.0 g/kg of body weight.
- Executive summary:
- In a study performed according to OECD 402 five healthy male and five healthy female New Zealand Albino rabbits were dosed dermally with Pamplefleur at 2.0 g/kg of body weight. All animals survived the 2.0 g/kg dermal application. Physical signs of diarrhea, yellow nasal discharge, few feces, emaciation, rales and soiling of the anogenital area were noted during the observation period. Body weight changes were normal in 8/10 animals. Two animals lost weight during the study. Dermal reactions, absent to slight on days 1 and 7, were absent on day 14. Necropsy results were normal in 7/10 animals. Gastrointestinal tract abnormalities, brown staining of the anogenital area and emaciation were noted in the remaining animals. The LD 50 is greater than 2.0 g/kg of body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
The study was conducted according to OECD guidelines and can be classed as a klimisch reliability 1 study.
Justification for selection of acute toxicity – dermal endpoint
The study was conducted according to OECD guidelines and can be classed as a klimisch reliability 1 study.
Justification for classification or non-classification
The acute lethal oral and dermal dose to rats of Pamplefleur were higher than 2/0 g/kg bodyweight. Based on these results the substance is not considered to be classified for acute oral or dermal toxicity in accordance with DSD 67/548/EC and the CLP Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.