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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
Endpoint summary
Administrative data
Description of key information
Skin Irritation:
A single semi-occlusive application of Pamplefleur to intact rabbit skin for four hours (according to OECD TG 404) elicited transient, slight dermal irritation: erythema scores were < 1.3 and edemal scores < 0.6, which were all fully reversible within 6 days.
Eye Irritation:
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.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 04 August 1987 and 09 August 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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White strain rabbits in the weight range 1. 9 to 3.1 kg, prior to treatment on Day 1 and approximately 9 to 14 weeks of age were obtained from Buckmasters, Henham, Hertfordshire, England. The rabbits selected for the study were all acclimated to the laboratory environment.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study.
The rabbits were individually housed in metal caqes with perforated floors in Buildinq R14 Room 3. They had free access to tap water and SDS Standard Rabbit Diet.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30-70%.
Air exchanqe was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.
All animals were observed daily for signs of ill health or toxic signs. - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0. 5 ml aliquot of Pamplefleur
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 6 days
- Number of animals:
- 3
- Details on study design:
- Treatment procedure
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorsa-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
A 0. 5 ml aliquot of Pamplefleur was applied under a 2. 5 cm square gauze pad to one intact skin site on each animal.
Each treatment site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period. The animals were not restrained during the exposure period and were returned to their cages.
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal: 651 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 Days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal: 652 Female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 Days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal: 653 Female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 Days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal: 651 male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 Days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal: 652 Female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 Days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal: 653 Female
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 Days
- Irritant / corrosive response data:
- Very sliqht erythema with very sliqht oedema was observed in all three animals. On Day 3, well-defined erythema with very sliqht oedema was
observed in one animal.
Desquamation of the stratum corneum was seen in two animals on Days 3 to 5 and in one animal on Days 4 and 5.
The skins were normal in all three animals by Day 6. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an OECD TG 404 test Pamplefleur elicited transient, slight dermal irritation.
- Executive summary:
An in vivo skin irritation study was according to OECD 404 was performed to assess skin irritation potential. A 0.5 ml aliquot of Pamplefleur was applied under a 2.5 cm square gauze pad to one intact skin site on each animal. Very sliqht erythema with very slight oedema was observed in all three animals. On Day 3, well-defined erythema with very slight oedema was observed in one animal. Desquamation of the stratum corneum was seen in two animals on Days 3 to 5 and in one animal on Days 4 and 5. The skins were normal in all three animals by Day 6. A single semi-occlusive application of Pamplefleur to intact rabbit skin for four hours elicited transient, slight dermal irritation, however, this was not enough for skin irritation classification.
Reference
Table 1 Dermal reactions elicited by Pamplefleur
Rabbit number and Sex |
E = Erythema O = Oedema |
Day |
|||||
1* |
2 |
3 |
4 |
5 |
6 |
||
651♂ |
E |
1 |
1 |
1D |
1D |
1D |
0 |
O |
1 |
0 |
1 |
0 |
0 |
0 |
|
652♀ |
E |
1 |
1 |
2 |
1D |
1D |
0 |
O |
0 |
0 |
1 |
1 |
0 |
0 |
|
653♀ |
E |
1 |
1 |
1D |
1D |
1D |
0 |
O |
1 |
0 |
1 |
0 |
0 |
0 |
* Approximately 60 minutes after removal of the dressing
D Desquamation of the stratum corneum
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing of Chemicals
- GLP compliance:
- yes
- 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. - 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. - 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.
- 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.
Reference
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).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One OECD TG 404 guideline study under GLP was available with a Klimisch reliability of 1.
Justification for selection of eye irritation endpoint:
One OECD TG 405 guideline study under GLP was available with a Klimisch reliability of 1.
Effects on eye irritation: irritating
Justification for classification or non-classification
Skin irritation
In an OECD 404 test transient, slight dermal irritation, which do not warrant classification according to the CLP Regulation (EC) No. 1272/2008 and to DSD 67/548/EC.
Eye irritation:
In an OECD 405 test effects are seen on conjunctivae and chemosis. Pamplefleur is not listed on Annex I of the DSD 67/548/EC (Index no. 603 -092 -00 -6) as an eye irritant. Under DSD 67/548/EC the substance does not fulfil the criteria as an eye irritant. However, under de CLP regulation EC 1272/2008 the substance should be classified as H319 (eye irritant 2), because conjunctival redness was seen at a score > 2 (2.3) in 2/3 animals.
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