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EC number: 203-118-2 | CAS number: 103-50-4
- 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:
- 1978-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented based on US CPSC method. Similar to OECD 404 with major but acceptable deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: US CPSC 1500.41
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 hour exposure, type of occlusion, number of readings, inclusion of abraded skin and no reversibility period included in testing
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dibenzyl ether
- EC Number:
- 203-118-2
- EC Name:
- Dibenzyl ether
- Cas Number:
- 103-50-4
- Molecular formula:
- C14H14O
- IUPAC Name:
- [(benzyloxy)methyl]benzene
- Details on test material:
- - Name of test material (as cited in study report): oxyde de dibenzyle
No further data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: hair clipped, and abraded/intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
No further data - Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 48 hrs after the removal of patch system
- Number of animals:
- Six
- Details on study design:
- SCORING SYSTEM: Draize system as required in the US CPSC guideline
No further data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- ca. 1.6
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other: no data - not measured/tested
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Very slight to well-defined erythema with very slight to slight oedema was in the intact and abraded sites of three animals at the 24 hours reading point. Very slight oedema was seen in the abraded site of one other animal. Very slight to well-defined erythema with or without very slight to moderate oedema was seen in two intact and four abraded sites ot the 72 hours reading.
Two animals did not show any observable response to treatment throughout the 72 hours observation period.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Animal | Symptoms | Toxicological findings | Primary irritation score | |||||
Intact skin | abraded skin | |||||||
24h | 72h | 7d | 24h | 72h | 7d | |||
1 | Erythema | 0 | 0 | - | 0 | 0 | - | Sum of all erythema and edema values for 24h and 72h divided by 24: PII= 1.6 |
Edema | 0 | 0 | - | 0 | 0 | - | ||
2 | Erythema | 0 | 0 | - | 0 | 0 | - | |
Edema | 0 | 0 | - | 0 | 0 | - | ||
3 | Erythema | 0 | 0 | - | 0 | 1 | - | |
Edema | 0 | 1 | - | 0 | 1 | - | ||
4 | Erythema | 1 | 1 | - | 0 | 1 | - | |
Edema | 1 | 1 | - | 0 | 0 | - | ||
5 | Erythema | 2 | 2 | - | 2 | 2 | - | |
Edema | 2 | 2 | - | 3 | 3 | - | ||
6 | Erythema | 1 | 1 | - | 2 | 2 | - | |
Edema | 1 | 1 | - | 2 | 2 | - |
Applicant's summary and conclusion
- Executive summary:
The authors tested the primary dermal irritation potential of dibenzyl oxide (CAS n° 103 -50 -4) on rabbits based on a US CPSC guideline section 1500.42. They exposed the abraded and intact back skin of six rabbits to 0.5 mL of raw material under occlusive conditions for 24 hours. Afterwards, the authors scored the effects on the skin based on the Draize system described into the guideline. They consecutively calculated a primary dermal irritation index.
Hence, in the test conditions, the authors found that dibenzyl oxide is a mild irritant to the skin of rabbits. Based on DSD or CLP criteria, no classification can be granted since individual scores are only available for a period limited to 48 hours after the end of exposure. However based on individual scores with intact skin within the first 48 hours, dibenzyl oxide should not be classified.
This study is well documented and based on generally well accepted scientific principles. The US CPSC guideline is strictly followed but since methodologies in this field roughly changed over the years, this evaluation method is considered reliable but considerable deviations to current guidelines should be understood and thus the study should be considered as reliable with restrictions, a Klimisch 2.c study.
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