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EC number: 939-526-9 | CAS number: 90506-73-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 27/7/2005 to 15/9/2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phosphoric acid, mono- and di-C16-18-alkyl esters
- EC Number:
- 291-938-1
- EC Name:
- Phosphoric acid, mono- and di-C16-18-alkyl esters
- Cas Number:
- 90506-73-3
- IUPAC Name:
- 90506-73-3
- Test material form:
- solid: pellets
- Details on test material:
- - Physical state: white solid pellet
- Analytical purity: 100 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Granja Cunícula San Bernardo s.L
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.3-2.6 kg
- Housing: individually in stainless steel cages with a grille floor placed on racks.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 55-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the test item - Duration of treatment / exposure:
- At first only one animal was used, applying three patches sequently for 3 minutes, 1 and 4 hours. After each one of these exposure periods, the corresponding bandage and patch were removed. The remaining test item was remioved with water. The test was completed using two other animals, applying a dressing to each one for 4 hours. After this exposure period, the bandages and patches were removed. The remaining test item was removed wih water.
- Observation period:
- The response in the application area was assessed after 60 minutes, 24, 48 and 72 hours after the period of exposure.
- Number of animals:
- Three female
- Details on study design:
- TEST SITE
- Area of exposure: 6.2 cm^2
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 60 min
- Score:
- 0.33
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Irritant / corrosive response data:
- At first only one animal was used and after 4 hours exposure to the test item, very slight erythema (hardly noticeable) (grade 1) was recorded one hour after removing the patch.
Any other information on results incl. tables
Primary Dermal Irrtation Test |
|||||
Nº animal (Exposure) |
Response |
60 min |
24 h |
48 h |
72 h |
2267 (3 minutes) |
Erythema |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
|
2267 (1Hour) |
Erythema |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
|
2267 (4hours) |
Erythema |
1 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
|
Primary Dermal Irrtation Test |
|||||
Nº animal (Exposure) |
Response |
60 min |
24 h |
48 h |
72 h |
2267 |
Erythema |
1 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
|
2269 |
Erythema |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
|
2271 |
Erythema |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- The test item is considered to be NON IRRITANT based on the criteria set out in Directive 2001/59/EC, Annex VI, and CLP, EU GHS (Regulation (EC) No 1272/2008)
- Executive summary:
In a primary dermal irritation study according to the OECD Guideline for the Testing of Chemicals 404 and Commission Directive 2004/73/EC Method B.4, 3 female, young adult New Zealand white rabbits were dermally exposed to 0.5 g of Phosphoric acid, mono- and di- C16-18 (even numbered) alkyl esters (100% a.i.) for 3 minutes, 1 and 4 hours to 6.2 cm² skin surface. Animals then were observed for 3 days.
No skin lesions were recorded after removing the patches applied for 3 minutes and 1 hour in the observation carried out 1 hour after removing the patches. After the 4 hour exposure to the test item, very slight erythema (hardly noticeable) (grade 1) was observed one hour after removing the patch. No skin lesions were observed in this animal during the observations made 24, 48 and 72 hours after removing the patches applied for 3 minutes, 1 hour or 4 hours. A semiocclusive patch with test tem was applied for 4 hours in the other two animals. No skin lesions were recorded in any of the animals during the observations made 1, 24, 48 and 72 hours after removing the patch. The means of the erythema and edema evaluations at 24, 48 and 72 hours for the three animals after a four-hour exposure were 0.00 (erythema) and 0.00 (edema).
In this study Phosphoric acid, mono- and di- C16-18 (even numbered) alkyl esters are not irritating to rabbit skin.
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