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EC number: 619-702-9 | CAS number: 33494-80-3
- 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
The substance was observed to be non corrosive in a corrositex assay.
An analogue of DTBPOK ( potassium dibenzyl phosphate), was considered highly irritant for the eye in a rabbit study.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- between 2012-07-23 to 2012-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- In accordance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2012-09-07
- Test system:
- human skin model
- Source species:
- human
- Details on test system:
- SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: Yes
Lot number CT052112
Expiry date May 2014
WAS THE COMPATIBILITY TEST PERFORMED: Yes
WAS THE TIMESCALE CATEGORY TEST PERFORMED: Yes
METHOD OF DETECTION
- Chemical or electrochemical detection system: Chemical detection system
METHOD OF APPLICATION: A membrane disc was placed on top of the vials. An aliquot of test item occupying 0.5 ml was evenly applied onto the top of the membrane disc.
NUMBER OF REPLICATES: 4
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the mean breakthrough time is less than 60 min as the substances was categorized in Category 2. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
VEHICLE
No vehicle
NEGATIVE CONTROL
- Concentration (if solution): 10% w/v - Duration of treatment / exposure:
- 60 min
- Number of replicates:
- 4
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 1 to 4
- Value:
- > 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be non-corrosive.
- Executive summary:
This in vitro study was performed to assess the skin corrosion potential of DTBPOK, in a corrositex assay according to the OECD 435 Guideline and GLP.
The qualification screen qualified the test item for the corrositex assay. The test item was assigned to category 2.
The results for the positive and negative control were acceptable.
In all four replicates, the breakthough time was > 60 minuges. Therefore, DTBPOK is considered to be non-corrosive.
Reference
Qualification Screen
The test item produced an immediate colour change therefore qualified for use in the CORROSITEX assay.
Categorisation Screen
The test item was assigned into Category 2.
Assay
|
Test item Breakthrough Time |
|||
Vial 1 |
Vial 2 |
Vial 3 |
Vial 4 |
|
Start time (hr:min:sec) |
00:00:00 |
00:04:00 |
00:05:00 |
00:06:00 |
Detection time (hr:min:sec) |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
Breakthrough time (hr:min:sec) |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
No breakthrough observed after 60 minutes
The results of the assay were accepted on condition of adherence to the positive and negative control item ranges given in the following table:
|
Chemical |
Concentration (weight %) |
Breakthrough Time (hr:min:sec) |
Positive Control |
Sulphuric Acid |
95 – 98 |
00 :01 :00 |
Negative Control |
Citric Acid |
10 |
>60 minutes |
hr = hour(s)
min = minute(s)
sec = second(s)
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- between 1997-06-02 to 1997-07-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- according to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 1996-21-02
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 16 weeks
- Weight at study initiation: 3.32 kg
- Housing: suspended metal cage
- Diet (e.g. ad libitum): ad libitum (STANRAB SQC Rabbit diet, special diets services, Witham, Essex, UK)
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes, at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21 °C
- Humidity (%): 51 to 70%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: To: 2 June 1997 to 23 June 1997 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (Approximately 20 mg) - Duration of treatment / exposure:
- Only one treatment
- Observation period (in vivo):
- just after the administration of the test item, 1h, 24h, 48h, 72h (according to the numerical evaluation from Draize J H 1977 "Dermal and Eye Toxicity test")
Additional observation were made on Days 7, 14 and 21 to assess the reversibility of the ocular test. - Number of animals or in vitro replicates:
- 1 animal
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
SCORING SYSTEM: according to the numerical evaluation from Draize J H 1977 "Dermal and Eye Toxicity test" in: Principles and Procedures for evaluating the toxicity of Household Substances, National Academy of sciences, Washington DC p 48-49
TOOL USED TO ASSESS SCORE: standard ophtalmoscope - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 55
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 5
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14d
- Irritant / corrosive response data:
- Individual and total scores for ocular irritation are given in table 1.
Areas of translucent corneal opacity were noted in the treated eye one hour after treatment with area of diffuse corneal opacity at the 24 and 48-hour observations, areas of translucent corneal opacity at 72-hour observation and diffuse 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 affect were noted
Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at the 24, 48 72-hour and 7-day observation with minimal conjunctival irritation at the 14 and 21-day observations. Pale green discolouration of the nictitating and conjunctival membranes was noted in the treated eye one hour after treatment. An off white appearance of the nictitating membrane and approximately half of the lower conjunctival membrane was noted in the treated eye at the 24, 48 and 72-hour and 7-day observations. An area of haemorrhage approximately 3 mm² in size on the conjunctival membrane of the lower eyelid was noted in the treated eye at 48 and 72-hour and 7-day observations. An abnormally shaped nictitating membrane was noted in the treated eye at the 14 and 21 day observations. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material produced a maximum total of 57 and was considered to be at least a SEVERE IRRITANT (Class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on the rabbit only).
Under the test conditions, test item is irritating to the eye rabbit and required the classification as Eye Dam. 1 (H318) according to the Regulation (EC) 1272/2008 (CLP). - Executive summary:
In an eye irritation study performed similarly to the OECD No. 405 guideline, 0.1 mL of undiluted test item was instilled into the right eye of 1 female New Zealand White Rabbits. The animal was then observed for 21 days for eye oedema and erythema of the conjunctivae, corneal opacity and iris lesion.
Eye irritation was assessed and scored according to the Draize scale at 24, 48 and 72 hrs after the instillation of the substance and then at days 7, 14 and 21.
The highest score was observed 1 hour after treatment. The effects was not fully reversible during the 21 days of observation, with still effect on conjonctivae ( redness and abnormally shaped nictitating membrane)
Under the test conditions, test item is considered as highly irritating to the eye rabbit and is therefore classified as Eye Dam. 1 (H318) according to the Regulation (EC) 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
Reference
Table 1: Acute irritation test in the rabbit: Individual Scores and total Scores for Ocular Irritation
Rabbit Number and Sex (Bodyweight kg) |
IPR = 3 |
||||||
63 Female (3.32) |
|||||||
Time after Treatment |
1 hour |
24 hours |
48 hours |
72 hours |
7 days |
14 days |
21 days |
CORNEA |
|
||||||
E = Degree of Opacity |
2 |
1 |
1 |
2 SI |
1 |
1 |
0 |
F = Area of opacity |
4 |
4 |
4 |
3 |
3 |
1 |
|
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 nictating and conjunctival membrane of lower eyelid
H = Area of haemorrhage approximately 3 mm² located on conjuntival membrane of lower eyelid
W = off white appearance of nictating membrane and approximately half of the lower conjunctival membrane
SI = sloughing of corneal membrane
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
An in vitro study was performed to assess the skin corrosion potential of DTBPOK, in a corrositex assay according to the OECD 435 Guideline and GLP.
The qualification screen qualified the test item for the corrositex assay. The test item was assigned to category 2.
The results for the positive and negative control were acceptable.
In all four replicates, the breakthough time was > 60 minuges. Therefore, DTBPOK is considered to be non-corrosive.
An in-vivo study (Safepharm 1997) acute eye irritation test in the
rabbit was performed to assess the eye irritation potential of potassium
dibenzyl phosphate (analogue of DTBPOK) according to the OECD 405
guideline. Results showed that potassium dibenzyl phosphate was
considered to be highly irritant for the eye.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available with the potassium dibenzyl phosphate (CAS
78543-37-0), which is an analogue of DTBPOK
Effects on eye irritation: highly irritating
Justification for classification or non-classification
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.
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