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EC number: 605-659-3 | CAS number: 173046-61-2
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]-2-[2-(2-prop-2-enoyloxypropoxy)ethoxymethyl]butoxy]ethoxy]propyl prop-2-enoate
- Cas Number:
- 118800-30-9
- Molecular formula:
- C6 H14 O3 . 3 (C3 H6 O . C2 H4 O)x . x C3 H4 O2
- IUPAC Name:
- 2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]-2-[2-(2-prop-2-enoyloxypropoxy)ethoxymethyl]butoxy]ethoxy]propyl prop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): Laromer PO 33 F
- Physical state: yellowish liquid
- Analytical purity: The test item is a complex mixture of isomers and homologues components, so no purity can be stated. (for details see analytical report BASF study-No.: 11L00272)
- Purity test date: 2011-12-19
- Lot/batch No.: 110007P040
- Stability under test conditions: guaranteed by the sponsor
- Storage condition of test material: room temperatur below 25°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: males: 8 weeks, females: 12 weeks
- Weight at study initiation: 212 ± 7.05g (males); 218.4 ± 4.39 g (females)
- Fasting period before study: no
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P); SDS Special diets services, Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12h / 12h
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: app. 40cm²
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24h (directly after removal of the semiocclusive dressing)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.89 ml/kg b.w.
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs: several times during exposure, daily thereafter;
body weight: day 0, weekly thereafter and on the last day of observation;
skin findings: 30-60 min after removal of the dressing, weekly thereafter according to Draize
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occured
- Clinical signs:
- no systemic effects were observed
local irritation (erythema up to grade 3, edema up to grade 1) were observed up to day 6 in males and up to day 10 in females. Scaling and incrustations were also observed in 1 and 2 females, respectively. - Body weight:
- normal body weight gain
- Gross pathology:
- no abnormalities found
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.
- Executive summary:
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.
· No mortality occurred
· No signs of systemic toxicity were observed in the animals
· The following test item-related local effects were recorded during the course of the study:
o Very slight to moderate erythema (grade 1 to 3)
o Very slight edema (grade 1)
o Incrustations (in two females)
o Scaling (in one female)
o Findings beyond the application area (in one female)
o All local effects were reversible until day 6 (males) or day 10 (females) at the latest
· The mean body weight of the animals increased within the normal range throughout the study period
· No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study
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