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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 10 June 1988 and 17 June 1988
- 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:
- other: OECD Guidelines for Testing of Chemicals
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pamplefleur
- IUPAC Name:
- Pamplefleur
- Test material form:
- other: clear colourless liquid
- Details on test material:
- Compound Description: 88-212-01 - clear colorless liquid
Lot No.: Not applicable
Base Factor: Not applicable
Amount Submitted: 202.07 grams (material and container)
Date submitted: June 2, 1988
Special Handling Instructions: Standard precautions
Analysis of Purity: The identity, purity, strength and stability of the test article are the responsibility of the sponsor.
Stability: There was no apparent change in the physical state of the test article during administration
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species: Rabbit
Strain: Albino New Zealand White
Supplier (Source): Camm Research, Wayne, New Jersey
Sex: Male and female
Age at Initiation: Healthy adult animals
No. on Study: Four ( 4 ) (two male and two female)
Method an Justification of Randomizotion: Stratification by sex, body weight and apparent good health.
Acclimation Period: Five (5) days
System of Identification: Cages marked with an animal group number and dose level. Rabbits were ear tagged.
Research Facility Registration: U.S.D.A. Registration No. 23-107 under the Animal Welfare Act 7 4: se 2131 et
Animal Rooms: Separate isolation by test system.
Light cycle - 12 hours light, 12 hours dark.
Temperature/Humidity - Maintained at a temperature of 20°C ± 3°C and a humidity of 30 to 70%.
Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
Sanitization: Waste material was removed twice weekly. Cages and feeders were sanitized every two weeks.
Food: Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging and scattering.
Food Analysis: There were no contaminants that were reasonably expected to be present in the dietary material known to be capable of interfering with the purpose or conduct of the study.
Water Analysis: Availability - fresh tap water, ad libitum. Water is monitored for contaminants at periodic intervals according to Standard Operating Procedure PH-018.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye, which remained untreated, served as a control.
- Amount / concentration applied:
- 0.1 ml/eye
- Duration of treatment / exposure:
- Up to 1 hour
- Observation period (in vivo):
- 7 Days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- Rationale for Test System: A variety of experimental animals have been used, but i t is recommended that testing be performed using healthy adult albino rabbits.
Compound Preparation: Dosed as received.
Rationale for Dose Selection: According to EPA Federal Register, Vol. 50, No. 188, Friday, September 27, 1985, and OECD Guidelines for Testing of Chemicals, adopted: 24 Feb 87.
Dose Administration: 0.1 ml/eye
Vehicle: Not applicable
Route of Administration: The test article was administered directly into the eye.
Rationale for Route of Administration: To evaluate the irritant potential of the test article on the eye.
Frequency and Duration of Administration: Once (1)
No. and description of Animals Per Dose Group: Four (4) (two males and two females)
No. and Code of Dose Group: Rabbit No. 8586-8589, Treatment 0.1 ml/right eye
Length of Study: Seven (7) days
Method of Study Performance: Both eyes of each experimental animal provisionally selected for testing were examined within 24 hours prior to testing by the same procedure used during the test examination. Animals showing eye irritation, ocular defects o r pre-existing corneal injury were not
used. The test substance was placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball.
The lids were then gently held together for about one second in order to limit loss of the material. The other eye, which remained untreated, served as a control.
Type and Frequency of Test, Analysis, and Measurements to be Made: The eyes were examined at 1, 24, 48 and 72 hours and on Day 7 after treatment. The grades of ocular reaction were recorded at each examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal: 8586 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal: 8587 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal: 8588 female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal: 8589 female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal: 8586 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal: 8587 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal: 8588 female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal: 8589 female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal: 8586 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect noted
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal: 8587 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect noted
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal: 8588 female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect noted
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal: 8589 female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect noted
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal: 8586 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect noted
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal: 8587 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect noted
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal: 8588 female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect noted
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal: 8589 female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect noted
- Irritant / corrosive response data:
- Positive ocular scores were recorded at the 1, 24, 48 and 72 hour observation periods. No positive scores were observed on Day 7 and the study was terminated at the sponsor's request.
Any other information on results incl. tables
The pH of the test article was not presented. In view of the chemical structure no strong reactivity is expected (e.g. absence of acidic or basic groups).
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In an OECD TG 405 test and using CLP criteria it is an eye irritant, while using the DSD criteria the substance is not an eye irritant.
- Executive summary:
In an OECD TG 405 study, 0.1 ml Pamplefleur, was instilled into the right eye of each of four rabbits. The cornea and iris scores were all zero. The conjunctivae scores were maximum 2.3 in 2/3 animals. In the two other animals this score was maximum 1. These conjuntivae effects were reversible within 7 days in 3/4 animals. the chemosis scores were maximum 1.6 and fully reversible within 7 days.
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