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EC number: 235-741-0 | CAS number: 12645-31-7
- 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:
- Experimental Start Date: 31 May 2011; Experimental Term Date: 16 Jun 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The dermal score for the initial animal was not performed on Day 14, but was performed on Day 15. This deviation did not appear to have an impact on the outcome of the study since the scores had not resolved and the conclusion did not change.
- GLP compliance:
- yes
- Remarks:
- Report includes EPA GLP Compliance letter
Test material
- Reference substance name:
- Reaction mass of bis(2-ethylhexyl) hydrogen phosphate and 2-ethylhexyl dihydrogen phosphate
- IUPAC Name:
- Reaction mass of bis(2-ethylhexyl) hydrogen phosphate and 2-ethylhexyl dihydrogen phosphate
- Details on test material:
- Sponsor's identification:Reaction mass of bis(2-ethylhexyl) hydrogen phosphate and 2-ethylhexyl dihydrogen phosphateCAS No:12645-31-7Identifier:TIS O2930, TISO0543, TIS O2384, MIN PR-1137Description:Clear liquidBatch number:CI1C0223Date received:25 May 2011Storage conditions:room temperature and humidity
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Animals were received from Millbrook Breeding Labs, Amherst, MA- Age at study initiation: The animals were approximately 3 months old.- Weight at study initiation: The pretest body weight range was 2.9 - 3.1 kg- Housing: The animals were individually housed in suspended cages.- Diet (e.g. ad libitum): Fresh Rabbit Chow (Diet #5321) was provided daily.- Water (e.g. ad libitum): Water was available as libitum- Acclimation period: At least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): The animal room was temperature controlled.- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped free of hair
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): The test article was dosed by volume, 0.5 ml/site.
- Duration of treatment / exposure:
- Exposure periods of 3 minutes (for initial animal), 1 hour (for initial animal) and 4 hours (for all animals).
- Observation period:
- Up to 15 days.
- Number of animals:
- 3 (1 initial animal then two additional animals).
- Details on study design:
- TEST SITE- Area of exposure: Each dose site was approximately 6 cm2.- Type of wrap if used: Initially, one rabbit was dosed sequentially on sites #1, 2 and 3. The test article was placed under a 2 x 3 cm gauze patch. Gentle pressure was applied to aid in the distribution of the test article over the prepared site. The rabbit was gently held in place and a piece of porous dressing was secured with non-irritating tape over dose site #1 (semi-occlusive) for the 3 minute exposure period. The torso was covered with a piece of porous dressing large enough to cover dose sites 2 & 3 with at least 5 cm square to spare on all sides of the gauze patch. Porous, non-irritating tape was used to encircle the trunk of the animal.REMOVAL OF TEST SUBSTANCEThe dressing and test article patch covering site #1 were removed at 3 minutes post dose, over site #2 at 1 hour post dose and the torso wrappings and patch covering site #3 at 4 hours post dose. All sites were gently washed with distilled water to remove residual test substance.DOSING OF ADDITIONAL ANIMALSSince no evidence of a corrosive or severely irritating effect was observed in the initial animal, two additional animals were added to the study. The animals were dosed at site #3 with 0.5 ml of test article. After an exposure period of 4 hours, the wrappings and patches were removed and the sites gently washed with distilled water.SCORING SYSTEM:Initial animal: Site #1 was scored for dermal irritation immediately and at 60 minutes following patches removal for the 3 minute exposure. Site #2 was scored at 60 minutes following the 1 hour exposure.All animals: Site #3 was scored at 60 minutes and at 24, 48 and 72 hours and on Days 7 and 15 for the initial animal and at 24, 48 and 72 hours and on Days 7 and 14 for the two additional animals following the 4 hour exposure.Erythema and edema were scored according to the numerical Draize technique. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Any additional signs were described. Draize scoring scheme:Erythema & Eschar No erythema: 0Very slight erythema (barely perceptible): 1Well defined erythema: 2Moderate to severe erythema: 3Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4Edema No edema: 0Very slight edema (barely perceptible): 1Slight edema (edges of area well-defined by definite raising): 2Moderate edema (raised approximately 1.0 mm): 3Severe edema (raised more than 1.0 mm, extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #1
- Remarks:
- initial animal
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #1
- Remarks:
- initial animal
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #1
- Remarks:
- initial animal
- Time point:
- 7 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Skin felt thickened and as though it had separated from the underlying tissue. Shiny areas were also observed.
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #1
- Remarks:
- initial animal
- Time point:
- other: 15 days
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Shiny areas observed.
- Irritation parameter:
- edema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #1
- Remarks:
- initial animal
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #1
- Remarks:
- initial animal
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: skin felt thickened on dose site after 48 h & 72 h
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #2
- Remarks:
- additional animal
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #2
- Remarks:
- additional animal
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #2
- Remarks:
- additional animal
- Time point:
- 7 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Skin felt thickened and as though it had separated from the underlying tissue.
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #2
- Remarks:
- additional animal
- Time point:
- 14 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Shiny areas observed.
- Irritation parameter:
- edema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #2
- Remarks:
- additional animal
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #2
- Remarks:
- additional animal
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: skin felt thickened on dose site and as though skin had seperated from underlying tissue
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #3
- Remarks:
- addiitonal animal
- Time point:
- other: 60 m
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #3
- Remarks:
- additional animal
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #3
- Remarks:
- additional animal
- Time point:
- 7 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Skin felt thickened
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #3
- Remarks:
- additional animal
- Time point:
- 14 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Shiny areas observed
- Irritation parameter:
- erythema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #3
- Remarks:
- additional animal
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #3
- Remarks:
- additional animal
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Remarks:
- (4 hour exposure)
- Basis:
- animal #3
- Remarks:
- additional animal
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: skin felt thickened on dose site
- Irritant / corrosive response data:
- Dermal Observations (Table 1 - attached background material).Initial animal:No erythema or edema was observed immediately following or at 60 minutes after patch removal following the 3 minute exposure. Slight erythema and no edema was observed at 60 minutes following the 1 hour exposure. Slight erythema and very slight edema was observed at 60 minutes, 24, 48 and 72 hours after patch removal following the 4 hour exposure. At 48 and 72 hours, the skin felt thickened. On Day 7, erythema was severe. The skin felt thickened and as though it had separated from the underlying tissue. Shiny areas were also observed. On Day 15, erythema was severe with shiny areas. No edema was observed on Days 7 or 15.2 additional animals:Erythema was slight to moderate at 1 hour post patch removal following the 4 hour exposure. Erythema was slight at 24 hours and 48 hours and very slight to slight at 72 hours. At 48 and 72 hours, the skin felt thickened and as though it had separated from the underlying tissue. Edema was slight at 1 hour and very slight at 24, 48 and 72 hours after patch removal following the 4 hour exposure. On Day 7, erythema was severe. The skin felt thickened for both animals and as though it had separated from the underlying tissue for one animal. On Day 14, erythema was severe with shiny areas. No edema was observed on Days 7 or 14.
- Other effects:
- Systemic Observations and Body Weights (Table 1 - attached background material).There were no abnormal physical signs noted during the observation period.
Any other information on results incl. tables
See attached background material for Table 1: Dermal Observations, Body Weights and Systemic Observations.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The substance is considered to be corrosive.
- Executive summary:
Objective:
To determine the irritant or corrosive effects, if any, of a test article when applied to the skin of a rabbit. This study was designed to comply with standards set forth in OECD Guideline for Testing of Chemicals, Number 404 Acute Dermal Irritation/Corrosion, adopted April 24, 2002.
Method Synopsis:
Since the test article was suspected to be a dermal irritant/corrosive substance, one healthy male New Zealand White rabbit was dosed dermally with the test article. The test article (0.5 ml) was applied dermally to three intact sites for an exposure period of 3 minutes on site #1, 1 hour on site #2 and 4 hours on site #3. Erythema and edema were scored immediately after patch removal following the 3 minute exposure and at 60 minutes after each patch removal for the 1 and 4 hour exposure. Site #3 was scored again at 24, 48 and 72 hours. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Since the reaction of the initial animal did not produce a corrosive or severely irritating effect, two additional animals (males) were added to the study. The two animals were dosed at site #3 for a four hour exposure. Erythema and edema were scored at 60 minutes, and at 24, 48 and 72 hours and on Days 7 and 15 for the initial animal and at 24, 48 and 72 hours and on Days 7 and 14 for the two additional animals.
Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. Body weights of all animals were recorded pre-test, 72 hours and at termination
Summary:
Initial animal:
No erythema or edema was observed immediately following or at 60 minutes after patch removal following the 3 minute exposure. Slight erythema and no edema was observed at 60 minutes following the 1 hour exposure. Slight erythema and very slight edema was observed at 60 minutes, 24, 48 and 72 hours after patch removal following the 4 hour exposure. At 48 and 72 hours, the skin felt thickened. On Day 7, erythema was severe. The skin felt thickened and as though it had separated from the underlying tissue. Shiny areas were also observed. On Day 15, erythema was severe with shiny areas. No edema was observed on Days 7 or 15.
2 additional animals:
Erythema was slight to moderate at 1 hour post patch removal following the 4 hour exposure. Erythema was slight at 24 hours and 48 hours and very slight to slight at 72 hours. At 48 and 72 hours, the skin felt thickened and as though it had separated from the underlying tissue. Edema was slight at 1 hour and very slight at 24, 48 and 72 hours after patch removal following the 4 hour exposure. On Day 7, erythema was severe. The skin felt thickened for both animals and as though it had separated from the underlying tissue for one animal. On Day 14, erythema was severe with shiny areas. No edema was observed on Days 7 or 14.
Conclusion:
The substance is considered to be corrosive.
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