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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-11-14 to 1990-01-18
- 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 81-4 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- not specified
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
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Source: Monsanto Company
Lot/batch no: 4321285
Purity: Not stated/determined
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farm, Hazleton, Pennsylvania
- Age at study initiation: Young Adults
- Housing: Individually housed in suspended stainless steel cages with wire mesh bottom
- Diet (e.g. ad libitum): Lab rabbit chow HF ad libitum
- Water (e.g. ad libitum): Automatic watering system ad libitum
- Acclimation period: 62 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21°C (given as 60-70°F)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
IN-LIFE DATES: From: 14/11/89 To: 18/01/90
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 0.1 ml was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for 1 second prior to releasing to prevent loss of material. No wash was performed after application, however, ~24 hours after application the treated eye was rinsed to remove any residual test material
- Observation period (in vivo):
- All animals were checked for viability twice daily.
Ocular irritation was evaluated at 1, 24, 48, and 72 hours after treatment. - Number of animals or in vitro replicates:
- 6 (4 males, 2 females)
- Details on study design:
- On the day before dosing, both eyes of each animal were examined using fluorescein dye to check for presence of corneal ulceration. Just prior to test material application, the eyes were examined again without fluorescein. Animals showing pre-existing corneal or conjunctival injury or irritation were not placed on study.
A single dose of 1 ml was administered to the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for 1 second prior to releasing to prevent loss of material. The left eye served as the control. The treated eyes were washed 24 hours after application to remove residual test material.
Scores were given for treated eyes according to EPA testing guidelines, included in appendix A of the report. "Eye irritation" is the production of reversible changes in the eye following application of test material to the anterior surface of the eye. "Eye corrosio" is the production of irreversible tissue damage in the eye following application of test material to the anterior surface of the eye. Fluorescein dye was used to confirm presence or absence of corneal ulceration in treated eyes starting with the 24 hour observation and at each subsequent observation until there was no stain retention for 2 observations.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness; Discharge
- Basis:
- animal #1
- Remarks:
- No. 8655
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness; Discharge
- Basis:
- animal #2
- Remarks:
- 8659
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness; Discharge
- Basis:
- animal #3
- Remarks:
- 8658
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness; Discharge
- Basis:
- animal #4
- Remarks:
- 8659
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness; Discharge
- Basis:
- animal #5
- Remarks:
- 8660
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness; Discharge
- Basis:
- animal #6
- Remarks:
- 8661
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animals 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animals 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animals 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Conjunctival irritation (redness, chemosis, discharge) in all animals at 1 hour, redness present in 1 male at 24 and 48 hours. 2 males exhibited slight dulling of cornea at 1 hour but recovered by 24 hours. No significant corneal or iridial changes were seen. All 6 animals were free of ocular irritation 24-72 hours after instillation of test material.
Any other information on results incl. tables
Scores are given for treated eyes. Unless otherwise noted, control (untreated) eyes had negative scores for all parameters. Scored according to scale presented in the scoring system presented in the section 'Any other information on materials and methods incl. tables'.
Table 1. Eye Irritation study in rabbits- individual ocular scores
|
Time after Administration (Hours) |
||||
1 |
24 |
48 |
72 |
Positive scores |
|
Animal No. 8655 M |
|||||
1. |
|||||
A. |
1 |
0 |
0 |
0 |
No |
B. |
1 |
0 |
0 |
0 |
No |
C. |
2 |
0 |
0 |
0 |
No |
D. |
0 |
0 |
0 |
0 |
No |
2. |
0 |
0 |
0 |
0 |
No |
3. |
|||||
A. |
0 |
0 |
0 |
0 |
No |
B. |
0 |
0 |
0 |
0 |
No |
C. |
0 |
0 |
0 |
0 |
No |
D. |
0 |
0f |
0f |
0 |
No |
Animal No. 8657 M |
|||||
1. |
|||||
A. |
1 |
0 |
0 |
0 |
No |
B. |
1 |
0 |
0 |
0 |
No |
C. |
1 |
0 |
0 |
0 |
No |
D. |
0 |
0 |
0 |
0 |
No |
2. |
0 |
0 |
0 |
0 |
No |
3. |
|||||
A. |
+ |
0 |
0 |
0 |
No |
B. |
4 |
0 |
0 |
0 |
No |
C. |
0 |
0 |
0 |
0 |
No |
D. |
0 |
0f |
0f |
0 |
No |
Animal No. 8658 F |
|||||
1. |
|||||
A. |
1 |
0 |
0 |
0 |
No |
B. |
1 |
0 |
0 |
0 |
No |
C. |
2 |
0 |
0 |
0 |
No |
D. |
0 |
0 |
0 |
0 |
No |
2. |
0 |
0 |
0 |
0 |
No |
3. |
|||||
A. |
0 |
0 |
0 |
0 |
No |
B. |
0 |
0 |
0 |
0 |
No |
C. |
0 |
0 |
0 |
0 |
No |
D. |
0 |
0f |
0f |
0 |
No |
Animal No. 8659 M |
|||||
1. |
|||||
A. |
1 |
0 |
0 |
0 |
No |
B. |
1 |
0 |
0 |
0 |
No |
C. |
2 |
0 |
0 |
0 |
No |
D. |
0 |
0 |
0 |
0 |
No |
2. |
0 |
0 |
0 |
0 |
No |
3. |
|||||
A. |
0 |
0 |
0 |
0 |
No |
B. |
0 |
0 |
0 |
0 |
No |
C. |
0 |
0 |
0 |
0 |
No |
D. |
0 |
0f |
0f |
0 |
No |
Animal No. 8660 F |
|||||
1. |
|||||
A. |
1 |
0 |
0 |
0 |
No |
B. |
1 |
0 |
0 |
0 |
No |
C. |
2 |
0 |
0 |
0 |
No |
D. |
0 |
0 |
0 |
0 |
No |
2. |
0 |
0 |
0 |
0 |
No |
3. Cornea |
|||||
A. |
0 |
0 |
0 |
0 |
No |
B. |
0 |
0 |
0 |
0 |
No |
C. |
0 |
0 |
0 |
0 |
No |
D. |
0 |
0f |
0f |
0 |
No |
Animal No. 8661 M |
|||||
1. |
|||||
A. |
2 |
1 |
1 |
0 |
Yes |
B. |
1 |
0 |
0 |
0 |
No |
C. |
2 |
0 |
0 |
0 |
No |
D. |
0 |
0 |
0 |
0 |
No |
2. |
0 |
0 |
0 |
0 |
No |
3. |
Cornea |
|
|
|
|
A. |
+ |
0 |
0 |
0 |
No |
B. |
4 |
0 |
0 |
0 |
No |
C. |
0 |
0 |
0 |
0 |
No |
D. |
0 |
0f |
0f |
0 |
No |
f - Observation confirmed with fluorescein
M - Male
F - Female
Table 2. Summary of responses
|
Positive (+) or Negative (-) Scores* |
|||||
Cornea |
Iris |
Conjunctivae |
||||
Opacity |
Ulceration |
Redness |
Chemosis |
Necrosis or Ulceration |
||
8655 M |
- |
- |
- |
- |
- |
- |
8657 M |
- |
- |
- |
- |
- |
- |
8658 F |
- |
- |
- |
- |
- |
- |
8659 M |
- |
- |
- |
- |
- |
- |
8660 F |
- |
- |
- |
- |
- |
- |
8661 M |
- |
- |
- |
+ |
- |
- |
* = Reference for positive and negative scores: See scoring system presented in the section 'Any other information on materials and methods incl. tables'.
M - Male
F - Female
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- XP-2563 produced mild, transient ocular irritation.
- Executive summary:
A key EPA OPPTS Guideline 81-4 study was conducted to evaluate the ocular irritation potential of the test material (XP-2563) in rabbits (Bio/dynamics Inc., 1990c). 0.1 mL of the test material was introduced into the lower conjunctival sac of the right eye of six New Zealand White albino rabbits (3/sex). The upper and lower eye lids were gently held together for one second prior to releasing to prevent loss of the test material. The contralateral eye served as the control.
No wash was performed subsequent to application but 24 hours post exposure, the treated eyes were rinsed to remove any residual test material. Eyes were evaluated and scored for ocular reactions at approximately 1, 24, 48, and 72 hours after treatment. Fluorescein dye was used to confirm presence or absence of corneal ulceration in treated eyes starting with the 24-hour observation and at each subsequent observation until there was no stain retention for two observations.
Irritation observed consisted primarily of conjunctival irritation (redness, chemosis, discharge) with most effects occurring at 1 hour. Two animals exhibited a slight dulling of the corneal surface but no significant corneal or iridial changes were observed. All six animals were free of ocular irritation within 24 to 72 hours post instillation of the test material.
It was concluded that the test material (XP-2563) produced mild, transient ocular irritation.
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