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EC number: 616-628-9 | CAS number: 78543-37-0
- 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:
- July 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 1996-01-21
Test material
- Reference substance name:
- potassium dibenzyl phosphate
- EC Number:
- 616-628-9
- Cas Number:
- 78543-37-0
- Molecular formula:
- C14-H14-O4-P.K
- IUPAC Name:
- potassium dibenzyl phosphate
- Test material form:
- solid
- Details on test material:
- Batch 97/8
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cherschire, UK
- Age at study initiation: 12 to 16 wekks old.
- Weight at study initiation: 3.32 kg
- Housing: suspended metal cage
- Diet (e.g. ad libitum): free access to food (STANRAB SQC rabbit diet, Special diets services Witham, Essex, UK)
- Water (e.g. ad libitum): Free access to water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21
- Humidity (%): 51 to 70 %
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12h continuous light and 12h darkness
IN-LIFE DATES: From: To: 2 june 1997 to 23 june 1997
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 mL - Observation period (in vivo):
- Approximately 1h, 24, 48,72h after treament.
aditional observations were made on day 7, 14 and 21 to assess the reversibilty of the occul r effects. - Number of animals or in vitro replicates:
- 1 animal
- Details on study design:
SCORING SYSTEM: Draize method
Examination of the eye was facilited by the use of a standard ophtalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 57
- Reversibility:
- not fully reversible within: 21 days
Any other information on results incl. tables
Areas of translucent corneal opacity were noted in the treated eye one hour after treatment with areas of diffuse corneal opacity at the 24 and 48-hour observation, area of translucent corneal opacity at the 7 and 14-day observations. Sloughing of the cornea was noted in the treated eye at the 72 -hour observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48, 72-hour and 7-day observations. No other iridial effects were noted.
Moderate conjunctival irritation was noted in the treated eye one hour after treatement and 24, 48, 72-hour and 7-day observations. Pale green discolouration of the nictitating and the conjunctival menbrane was noted in the treated eye one hour after treatment. An off white appearance of the nictating membrane and approximately half of the lower conjunctival membrane was noted in the treated eye at the 24, 48, 72-hour and 7-day observations. An aera of haemorrhage approximately 3 mm² in size on the conjunctival membrane of the lower eyelid was noted in the treated eye at the 48, 72-hour and 7-day obsevations. An abnormally shaped nictating membrane was noted in the treated eye at he 14 and 21-day observations.
Individual scored and total scores for ocular irritation
Rabbit Number and sex (Bodyweight kg) |
IPR = 3 |
|||||||
Time after treatment |
63 Female (3.32) |
|||||||
|
|
1 hour |
24 hours |
48 hours |
72 hours |
7 days |
14 days |
21 days |
CORNEA |
E = Degree of opacity |
2 |
1 |
1 |
2SI |
1 |
1 |
0 |
F = Area of Opacity |
4 |
4 |
4 |
3 |
3 |
1 |
0 |
|
Score (E x F) x 5 |
40 |
20 |
20 |
30 |
15 |
5 |
0 |
|
IRIS |
D |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
Score (D x 5) |
5 |
5 |
5 |
5 |
5 |
0 |
0 |
|
CONJUNCTIVAE |
A = Redness |
2G |
2W |
2WH |
2WH |
2WH |
1AB |
1AB |
B = CHEMOSIS |
2 |
2 |
2 |
2 |
2 |
1 |
0 |
|
C = Discharge |
2 |
3 |
3 |
1 |
1 |
0 |
0 |
|
Score (A+B+C) x 2 |
12 |
14 |
14 |
10 |
10 |
4 |
2 |
|
Total Score |
57 |
39 |
39 |
45 |
30 |
9 |
2 |
IPR = initial pain reaction
AB = Abnormally shaped nictitating membrane
G = Pale green discolouration of the nictitating and conjunctivalmembranes
H = area of haemorrhage approximately 3mm² located on conjunctival membrane of lower eyelid
W = off white appearance of nictitating membrane and approximately half of the lower conjunctival membrane
SI = sloughing of corneal membrane
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The dibenzyl Potassium Phosphate was considered to be corrosive to the eye.
- Executive summary:
The eye irritation of Dibenzyl Potassium Phosphate has been determinated according to OECD 405 test guideline in compliance with GLP.
The substance was determinated to be corrosive to the eye.
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