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Diss Factsheets
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EC number: 942-466-6 | 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1998-08-11 to 1998-08-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented guideline study in compliance with GLP (conducted with a read-across substance)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of Health of the Government of the United Kingdom
Test material
- Test material form:
- other: viscous liquid
- Details on test material:
- - Molecular formula (if other than submission substance): C28H62NO4P (for a representative structure: Phosphoric acid, di(C8)ester, compds with C12 amine)
- Molecular weight (if other than submission substance): 507.76
- Smiles notation (if other than submission substance): CCCCCCCCCCCCN.O=P(O)(OCCCCCCCC)OCCCCCCCC
- InChl (if other than submission substance): InChI=1/C12H27N/c1-2-3-4-5-6-7-8-9-10-11-12-13/h2-13H2,1H3
- Physical state: extremely pale straw coloured viscous liquid
- Storage condition of test material: room temperature in the dark
- Other: Data relating to the identity, purity and stability of the test material are the responsibility of the Sponsor.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.75 to 2.90 kg
- Housing: individually housed in suspended metal cages
- Diet/Water (e.g. ad libitum): free access to mains drinking water and food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK)
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 25
- Humidity (%): 65 to 74
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 2 males / 1 female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm); wrapped in an elasticated corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton
wool soaked in distilled water.
SCORING SYSTEM:
-Method by Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal: 2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal: 3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal: 1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal: 2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal: 3
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- - Well-defined erythema (24 and 48-hour observations);
- Well-defined erythema to very slight erythema (72-hour observation);
- Moderate oedema, slight oedema (1-hour observation);
- Slight oedema (24 and 48-hour observations);
- Slight oedema, very slight oedema (72-hour observation). - Other effects:
- Loss of skin elasticity (48 and 72-hour observation), crust formation (7 days after treatment): fully reversible within 14 days.
Any other information on results incl. tables
Well defined erythema was noted at all treated skin sites one hour after patch removal and at the 24 and 48-hour observations. Well-defined erythema was noted at one treated skin site with very slight erythema at two treated skin sites at the 72-hour observation.
Moderate oedema was noted at one treated skin site with slight oedema at two treated skin sites one hour after patch removal. Slight oedema was noted at all treated skin sites at the 24 and 48-hour observations. Slight oedema persisted at one treated skin site with very slight oedema at two treated skin sites at the 72-hour observation.
Loss of skin elasticity was noted at one treated skin site at the 48-hour observation and at all treated skin sites at the 72-hour observation. Crust formation was noted at one treated skin site with slight desquamation at two treated skin sites at the 7-day observation. Treated skin sites appeared normal at the 14-day observation.
Table 1. Individual Skin Reactions
Skin Reaction | Observation Time | Individual Scores - Rabbit Number and Sex (Bodyweight kg) | Total | ||
10 Male (2.75) | 36 Male (2.90) | 78 Male (2.88) | |||
Erythema/Eschar Formation | 1 Hour | 2 | 2 | 2 | ( 6 ) |
24 Hours | 2 | 2 | 2 | 6 | |
48 Hours | 2 | 2 | 2 Le | (6) | |
72 Hours | 1 Le | 1 Le | 2 Le | 4 | |
7 Days | 0 D | 0 D | 0 Cf | (0) | |
14 Days | 0 | 0 | 0 | (0) | |
Oedema Formation | 1 Hour | 2 | 3 | 2 | ( 7 ) |
24 Hours | 2 | 2 | 2 | 6 | |
48 Hours | 2 | 2 | 2 | (6 ) | |
72 Hours | 1 | 1 | 2 | 4 | |
7 Days | 0 | 0 | 0 | (0 ) | |
14 Days | 0 | 0 | 0 | (0) | |
Sum of 24 and 72-hour Readings (S) | 20 | ||||
Primary Irritation Index (S/6) | 20/6 = 3.3 | ||||
Classification | MODERATE IRRITANT |
( ) = Total values not used for calculation of primary irritation index; Cf = crust formation; D = desquamation; Le = loss of skin elasticity
Table 2. Individual Daily and Mean Scores for Dermal Irritation following 4 -hour Exposure required for EU Labelling Regulations
Skin Reaction | Skin ReactionReading (Hours) | Individual Scores - Rabbit Number and Sex (Bodyweight kg) | ||
10 Male (2.75) |
36 Male (2.90) |
78 Male (2.88) |
||
Erythema/Eschar Formation | 24 | 2 | 2 | 2 |
48 | 2 | 2 | 2 | |
72 | 1 | 1 | 2 | |
Total | 5 | 5 | 6 | |
Mean Score | 1.7 | 1.7 | 2.0 + | |
Oedema Formation | 24 | 2 | 2 | 2 |
48 | 2 | 2 | 2 | |
72 | 1 | 1 | 2 | |
Total | 5 | 5 | 6 | |
Mean Score | 1.7 | 1.7 | 2.0 + |
+ = positive criterion
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- According to Regulation (EC) No 1272/2008, the test material is not classified as skin irritant or corrosive. Mean values for erythema/eschar or for oedema from gradings at 24, 48 and 72 hours after patch removal amount up to 2 (under the cut-off value of 2.3).
- Executive summary:
An OECD Guideline 404 study was performed to assess the irritancy potential of phosphoric acid, mono- and di-(C8 -C10) ester, compds. with C12 -14 amine to the skin of the New Zealand White rabbit in compliance with GLP. A single 4-hour, semi-occluded application of 0.5 mL of the test material to the intact skin of three rabbits (2 males / 1 female) produced well-defined erythema and slight to moderate oedema. Observations were performed 1 h, 24 h, 48 h, 72 h, 7 d and 14 d after application. Loss of skin elasticity, crust formation and slight desquamation were also noted. Treated skin sites appeared normal at the 14-day observation. The test material produced a primary irritation index of 3.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.
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.
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