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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-11-14 to 1990-04-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- FIFRA: Pesticide Assessment Guidelines (Primary Dermal Irritation Study);
TSCA: Health Effects Test Guidelines (Acute Exposure, Primary Dermal Irritation) - Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenol
- EC Number:
- 203-632-7
- EC Name:
- Phenol
- Cas Number:
- 108-95-2
- Molecular formula:
- C6H6O
- IUPAC Name:
- phenol
- Reference substance name:
- 1-chlorododecane
- Molecular formula:
- C12H25Cl
- IUPAC Name:
- 1-chlorododecane
- Reference substance name:
- 1-Dodecanol
- Cas Number:
- 112-53-8
- Molecular formula:
- C12H26O
- IUPAC Name:
- 1-Dodecanol
- Reference substance name:
- 1-Tetradecanol
- Cas Number:
- 112-72-1
- Molecular formula:
- C14H30O
- IUPAC Name:
- 1-Tetradecanol
- Reference substance name:
- triphenyl phosphate
- Cas Number:
- 115-86-6
- Molecular formula:
- C18H15O4P
- IUPAC Name:
- triphenyl phosphate
- Reference substance name:
- -
- EC Number:
- 431-760-5
- EC Name:
- -
- Cas Number:
- 27460-02-2
- Molecular formula:
- C24H35O4P
- IUPAC Name:
- dodecyl diphenyl phosphate
- Reference substance name:
- diphenyl tetradecyl phosphate
- Cas Number:
- 142474-86-0
- Molecular formula:
- C26H39O4P
- IUPAC Name:
- diphenyl tetradecyl phosphate
- Reference substance name:
- Didodecyl phenyl phosphate
- Cas Number:
- 56827-93-1
- Molecular formula:
- C30H55O4P
- IUPAC Name:
- Didodecyl phenyl phosphate
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 6 (3 males 3 females) young adults (at least 8 weeks old at study initiation) Albino rabbits (New Zealand White) were chosen for dermal irritation studies. The New Zealand White breed was used because of its historical and because of the existing historical database for comparative evaluation. All animals were checked for viability twice daily. Prior to assignment to study all animals were examined to ascertain suitability for study.
The rabbits were individually housed in suspended, stainless steel with wire mesh bottoms in a temperature (60-70°F – monitored and recorded twice daily) and humidity (30-70% - monitored and recorded daily) controlled room with a 12 hour light, 12 hour dark cycle controlled by an automatic timer.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL of test material per site (the material was applied to two intact sites on eachO animal)
- Duration of treatment / exposure:
- single 4 hour exposure
- Observation period:
- 7-14 days
- Number of animals:
- 6
- Details on study design:
- On the day before dosing, the hair of each rabbit was clipped from the dorsal area of the trunk with an electric clipper so as to expose at least 10% of the body surface area, Care was taken to avoid abrading the skin. Only animals with intact, healthy skin were used.
The test material was administered as received. An appropriate amount of the test material was applied beneath a gauze square 1'' x 1'', placed directly on the test site and held in place with tape and a semi-occlusive covering. Elizabethean collars were placed on each animal prior to or at the time of dosing in order to prevent the animal from disturbing the wrapping and test sites.
Following 4 hours of exposure, the wrappings and gauze squares were removed and the test site was gently wiped free of excess test material using water and gauze. After approximately 30 minutes, dermal observations were made and scoring done according to the method of Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24/72 hr
- Score:
- 2.1
- Reversibility:
- not fully reversible within: 14 days
- Remarks:
- 5 of the 6 animals were free of signs of dermal irritation. 1 animal continued to exhibit very slight (barely perceptible) dermal irritation at study termination.
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Irritant / corrosive response data:
- All six animals exhibited slight erythema with little or no edema. By Day 14, 5 of the 6 animals were free of signs of dermal irritation while 1 animal continued to exhibit very slight (barely perceptible) dermal irritation at study termination.
Any other information on results incl. tables
Table 1. Primary dermal irritation study in rabbits (4-hour exposure/semi-occlusive covering)
Time intervalb |
Patch Sites & Observations |
Animal Number and Sex |
Mean Score |
||||||
8648F |
8649M |
8650F |
8651M |
8652F |
8563M |
||||
0.5 Hours |
Right |
ER |
0 |
1 |
1 |
0 |
1 |
0 |
- |
ED |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Other |
- |
- |
- |
- |
- |
- |
|||
Left |
ER |
0 |
1 |
0 |
0 |
1 |
0 |
||
ED |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Other |
- |
- |
- |
- |
- |
- |
|||
24 Hours |
Right |
ER |
2 |
2 |
2 |
2 |
2 |
2 |
2.0 |
ED |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
- |
- |
- |
- |
- |
- |
- |
||
Left |
ER |
2 |
2 |
2 |
2 |
2 |
2 |
2.0 |
|
ED |
0 |
1 |
0 |
0 |
0 |
1 |
0.3 |
||
Other |
- |
- |
- |
- |
- |
- |
- |
||
48 Hours |
Right |
ER |
2 |
2 |
2 |
2 |
2 |
2 |
- |
ED |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Other |
- |
- |
- |
- |
- |
- |
|||
Left |
ER |
2 |
2 |
2 |
2 |
2 |
2 |
||
ED |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Other |
- |
- |
- |
- |
- |
- |
|||
72 Hours |
Right |
ER |
2 |
2 |
2 |
2 |
2 |
2 |
2.0 |
ED |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
- |
- |
- |
- |
- |
- |
- |
||
Left |
ER |
2 |
2 |
2 |
2 |
2 |
2 |
2.0 |
|
ED |
0 |
0 |
0 |
0 |
0 |
0 |
0.2 |
||
Other |
- |
- |
- |
- |
- |
- |
- |
||
Day 7 |
Right |
ER |
2 |
0 |
0 |
2 |
2 |
2 |
N/A |
ED |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Other |
D |
- |
- |
- |
- |
- |
|||
Left |
ER |
2 |
0 |
0 |
2 |
2 |
1 |
||
ED |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Other |
0 |
- |
0 |
- |
- |
- |
|||
Day 10 |
Right |
ER |
0 |
- |
- |
1 |
0 |
1 |
|
ED |
0 |
- |
- |
0 |
0 |
0 |
|||
Other |
D |
- |
- |
- |
- |
- |
|||
Left |
ER |
0 |
- |
- |
1 |
0 |
1 |
||
ED |
0 |
- |
- |
0 |
0 |
0 |
|||
Other |
D |
- |
- |
- |
- |
- |
|||
Day 14 |
Right |
ER |
- |
- |
- |
1 |
- |
0 |
|
ED |
- |
- |
- |
0 |
- |
0 |
|||
Other |
- |
- |
- |
- |
- |
- |
|||
Left |
ER |
- |
- |
- |
0 |
- |
0 |
||
ED |
- |
- |
|
0 |
- |
0 |
|||
Other |
- |
- |
|
0 |
- |
- |
b Time indicated is time from patch removal
M = male; F = female; ER = Erythema; ED = Edema; D = Desquamation
Sum of means = 8.5
Average Dermal irritation score = 2.1
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- All 6 animals exhibited slight erythema with little or no edema. By Day 14, 5 of 6 animals were free of signs of dermal irritation; one animal continued to exhibit very slight (barely perceptible) dermal irritation at study termination (Day 14)
It was therefore concluded that XP-2563 produced mild by generally reversible dermal irritation. The average dermal irritation score of XP-2563 is 2.1 Animal experience or test data that indicates that the substance/mixture causes reversible damage to the skin following exposure of up to 4 hours, mean value of ≥1.5 < 2.3 for erythema/eschar in 2 of 3 tested animals. - Executive summary:
This study was intended to provide information on the health hazards likely to arise from a short-term accidental exposure to the test material by the dermal route. 6 (3 males 3 females) young adults (at least 8 weeks old at study initiation) Albino rabbits (New Zealand White) were chosen for dermal irritation studies. XP-2563 was applied to two intact sites on each animal, with a dosage of 0.5 ml per site, for an exposure period of approx. 4 hours under semi-occlusive conditions.
The results showed that all 6 animals exhibited slight erythema with little or no edema. By Day 14, five of six animals were free of signs of dermal irritation; one animal continued to exhibit very slight (barely perceptible) dermal irritation at study termination (Day 14)
It was therefore concluded that XP-2563 produced mild by generally reversible dermal irritation. The average dermal irritation score of XP-2563 is 2.1.
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.