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EC number: 700-012-2 | CAS number: 950919-28-5
- 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:
- From July 15 to 29, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Adopted 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on August 19, 2008/ signed on March 04, 2009)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 7-(propan-2-yl)-3,4-dihydro-2H-1,5-benzodioxepin-3-one
- EC Number:
- 700-012-2
- Cas Number:
- 950919-28-5
- Molecular formula:
- C12H14O3
- IUPAC Name:
- 7-(propan-2-yl)-3,4-dihydro-2H-1,5-benzodioxepin-3-one
- Test material form:
- solid
- Remarks:
- paste / solid block
- Details on test material:
- - Physical state: solid, pale yellow to yellow block, or pasty
- Stability under test conditions: no data
- Storage condition of test material: in the dark, preferably at about 4-10°C and under nitrogen.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: At least 200 g
- Housing: Animals were housed individually during the 24 h exposure period and in groups of five by sex for the remainder of the study in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: Food (2014 Teklad Global Rodent diet supplied by, Harlan Teklad, Bicester, Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 changes/h
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: July 15, 2009 To: July 29, 2009
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back and flank area
- % coverage: Approximately 10 % of the total body surface area.
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24 h contact period, the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: Yes; 1.78 mL/kg bw
- For solids, paste formed: Yes; the test material was melted in a warming bath set at 60 °C and allowed to cool prior to dosing. - 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
- Frequency of observations and weighing: Animals were observed for mortality or clinical signs of toxicity at 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes; at the end of the study animals were killed by cervical dislocation and subjected to gross necropsy. - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed.
- Mortality:
- - No mortality was observed.
- Clinical signs:
- - No signs of dermal irritation and systemic toxicity were observed.
- Body weight:
- - Animals showed expected gains in bodyweight over the study period, except for two females which showed no gain in bodyweight and one female which showed bodyweight loss during the first week but expected gain in bodyweight during the second week.
- Gross pathology:
- - No abnormalities were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
Table 7.2.3/1: Individual bodyweights and bodyweight changes
Dose level (mg/kg bw) |
Animal number and sex |
Body weight (g) at Day |
Body weight gain (g) during week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Male |
312 |
314 |
332 |
2 |
18 |
1-1 Male |
312 |
322 |
342 |
10 |
20 |
|
1-2 Male |
319 |
325 |
342 |
6 |
17 |
|
1-3 Male |
316 |
336 |
343 |
20 |
7 |
|
1-4 Male |
312 |
316 |
333 |
4 |
17 |
|
2-0 Female |
200 |
196 |
212 |
-4 |
16 |
|
2-1 Female |
201 |
205 |
217 |
4 |
12 |
|
2-2 Female |
202 |
202 |
212 |
0 |
10 |
|
2-3 Female |
201 |
207 |
218 |
6 |
11 |
|
2-4 Female |
208 |
208 |
219 |
0 |
11 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the dermal LD50 for the registered substance is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute dermal toxicity study (limit test) performed according to OECD Guideline No. 402 and in compliance with GLP, a group of Wistar (HsdRccHan®™:WIST®™) rats (5/sex) was given a single dermal application of the undiluted test material at 2000 mg/kg bw to intact skin of the back and flank area at the dose volume of 1.78 mL/kg bw. Test sites were covered with a semi-occlusive dressing for 24 h. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Skin irritation was assessed and scored according to the Draize scale at 24 h after removal of the dressings and then daily for 14 days.
No mortality, dermal irritation or systemic toxicity were observed. Animals showed expected gains in bodyweight over the 14 day study period, except for two females which showed no gain in bodyweight and one female which showed bodyweight loss during the first week but expected gain in bodyweight during the second week. No abnormalities were noted at necropsy.
Dermal LD50 Combined > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.
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