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EC number: 220-499-0 | CAS number: 2785-87-7
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Basic data given but study reported to be performed according to OECD 429 with deviations: purity of test item not reported, number of animals per group, positive controls and body weight not reported; no ear thickness measurement nor excessive irritation assessment. Considered sufficiently reliable in a weight of evidence for the purpose of hazard assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Compilation of Historical Local Lymph Node Data for Evaluation of Skin Sensitization Alternative Methods
- Author:
- Gerberick GF, Ryan CA, Kern PS, Schlatter H, Dearman RJ, Kimber I, Patlewicz GY and Basketter DA
- Year:
- 2 005
- Bibliographic source:
- Dermatitis, 16 (4):157-202
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- details on environmental conditions of animal room, number of animals per group, positive controls and body weight not reported; no ear thickness measurement nor excessive irritation assessment
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-methoxy-4-propylphenol
- EC Number:
- 220-499-0
- EC Name:
- 2-methoxy-4-propylphenol
- Cas Number:
- 2785-87-7
- Molecular formula:
- C10H14O2
- IUPAC Name:
- 2-methoxy-4-propylphenol
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Dihydroeugenol
- Purity: No data
- Log Kp: - 2.20
- Log Ko/w: 2.15
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7-12 weeks
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5.1, 10.1 and 25.3 % in 4:1 acetone/olive oil
- No. of animals per dose:
- No data
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: A substance was classified as a skin sensitizer if, at one or more test concentrations, it induced a 3-fold or greater increase in local lymph node proliferative activity when compared with concurrent vehicle-treated controls (SI, ≥ 3).
TREATMENT PREPARATION AND ADMINISTRATION:
25 µL of control or test material was applied to the dorsum of both ears daily for three consecutive days. Five days after the initiation of exposure, all animals were injected via the tail vein with 250 µL of phosphate-buffered saline containing 20 µCi of tritiated thymidine. Animals were sacrificed 5 h later and the draining auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by beta scintillation counting was reported in disintegrations per minute (DPM). Stimulation index (SI) was calculated for each treated group as the ratio of the DPM in the treated group (or mean DPM when individual animals were assessed) to the DPM or mean DPM of the concurrent vehicle control group. - Positive control substance(s):
- not specified
- Statistics:
- No data
Results and discussion
- Positive control results:
- No data
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- 6.8
- Parameter:
- SI
- Value:
- 2.7
- Test group / Remarks:
- 5.1%
- Parameter:
- SI
- Value:
- 3.6
- Test group / Remarks:
- 10.1%
- Parameter:
- SI
- Value:
- 7.8
- Test group / Remarks:
- 25.3%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Not reported
DETAILS ON STIMULATION INDEX CALCULATION
Stimulation index for test material at 5.1, 10.1 and 25.3 % were 2.7, 3.6 and 7.8, respectively.
EC3 CALCULATION
Calculated EC3 value for the test material was found to be 6.8 %
CLINICAL OBSERVATIONS:
Not reported
BODY WEIGHTS
Not reported
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the test conditions, test material is classified as “Category 1B” moderate skin sensitiser according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS. Due to the lack of reported details (purity of test item, number of animals per group, positive controls and body weight not reported; no ear thickness measurement nor excessive irritation assessment reported), the study was not used in its own to classify the substance but it was considered sufficiently reliable in a weight of evidence for the purpose of hazard assessment.
- Executive summary:
In a Local Lymph Node Assay (LLNA), groups of female CBA mice were topically applied with test material at the dose concentrations of 5.1, 10.1 and 25.3 % final concentration in 1:4 acetone:olive oil to the dorsum of both ears (25 µL/ear) daily for three consecutive days. A vehicle control group was treated with 1:4 acetone:olive oil alone in the same manner. Five days after the initiation of exposure, all animals were injected via the tail vein with 250 µL of phosphate-buffered saline containing 20 µCi of tritiated thymidine. Tritiated thymidine incorporation was quantified using a beta scintillation counter and stimulation index (Sl) was calculated for each dose group.
Stimulation Index (SI Value) calculated for test material treated groups were found to be 2.7, 3.6 and 7.8 for the dose concentrations of 5.1, 10.1 and 25.3 %, respectively. Calculated EC3 value for the test material was found to be 6.8 %.
Under the test conditions, test material is classified as “Category 1B” skin sensitiser according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Due to the lack of reported details (purity of test item, number of animals per group, positive controls and body weight not reported; no ear thickness measurement nor excessive irritation assessment reported), the study was not used in its own to classify the substance but it was considered sufficiently reliable in a weight of evidence for the purpose of hazard assessment.
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