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EC number: 500-336-2 | CAS number: 157348-58-8
- 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:
- 2016-03-08 to 2016-03-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted July 28, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid
- EC Number:
- 500-336-2
- EC Name:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid
- Cas Number:
- 157348-58-8
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- Copolymer of neodecanoic acid oxiranylmethyl ester and phosphorous acid
- Test material form:
- other: Colourless, viscous liquid
- Details on test material:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid manufactured by Evonik Degussa GmbH, Batch 1524201 of 2015-12-22.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Sex: female
- Age: approx.4 months
- Weight at study initiation: 3.7 kg - 4.3 kg
- Housing: single
- Diet: ad libitum, Commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: untreated skin surrounding the application area
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml test item/patch and animal
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: unchanged
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance, approx. 6 cm2
- Concentration: 0.5 mL of the test item was applied to the test site (area: approx. 6 cm2).
- Occlusion: gauze patch held in place by semi-occlusive non-irritating tape dressing
- Inital test:
Three test patches were applied sequentially to the animal. The first patch was removed after three minutes
As no serious skin reaction was observed, a second patch was applied at a different site and removed after one hour.
No skin reactions were observed, neither. So a third patch was applied and removed after 4 hours.
After the end of exposure time, no residual test item had to be removed.
- Confirmatory test:
As no skin reactions were observed in the initial test, the test was completed using two additional animals, each with one patch only, for an exposure period of 4 hours.
- Washing: at the end of the exposure time no residual test item had to be removed.
EXAMINATIONS
- After the 4-hour exposure period the patch was removed and the skin sites were evaluated.
- Examination time points: 60 minutes, 24, 48, 72 hours,
- Scoring system: Draize (0-4 possible scores each for erythema/eschar and for edema)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0
- Edema: 0 - Other effects:
- no other effects
Any other information on results incl. tables
Findings Examination Skin irritation scores
of the skin schedule
animal no.
1 2 3
E/Oe E/Oe E/Oe
500 mL substance/patch/animal
erythema and
eschar formations/ before dosing 0/0 0/0 0/0
oedema formation
time after removal after 3 -minute appl (patch 1) 0/0
after 1 hour appl (patch 2) 0/0
after 4 hour exp (patch 3) 0/0
of the patch
(4-hour exposure) patch 3 patch 1 patch 1
60 min 0/0 0/0 0/0
24 hours 0/0 0/0 0/0
48 hours 0/0 0/0 0/0
72 hours 0/0 0/0 0/0
0 no pathological findings
E erythema and eschar formations
Oe oedema
Applicant's summary and conclusion
- Conclusions:
- According to the study, the test item showed no irritant effects on the skin of female rabbits.
- Executive summary:
The purpose of this study was to examine the test item for acute dermal irritation/corrosion properties in rabbits (patch test).
Under the present test conditions, none of three rabbits exposed for 4 hours to 0.5 mL test item/patch (semi-occlusive conditions) revealed any skin reaction.
There were no systemic intolerance reactions.
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