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EC number: 203-253-7 | CAS number: 104-93-8
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to current guidelines and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-methylanisole
- EC Number:
- 203-253-7
- EC Name:
- 4-methylanisole
- Cas Number:
- 104-93-8
- Molecular formula:
- C8H10O
- IUPAC Name:
- 1-methoxy-4-methylbenzene
- Details on test material:
- - Name of test material (as cited in study report): p-Cresolmethylether
- Physical state: liquid, colorless, clear
- Analytical purity: 98.6%
- Batch No.: 107450 09T0
- Stability under test conditions: stability analytically verified
- Storage condition of test material: room temperature, protection from light
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 19.4 - 22.2 g
- Housing: single, Makrolon Type II, with wire mesh top (EHRET GmbH, 79302 Emmendingen, Germany)
- Diet (e.g. ad libitum): Pelleted standard diet, ad libitum (Harlan Laboratories B.V., 5960 AD Horst / Netherlands)
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 20 - 65
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 10, 25 and 50% (w/v) test item
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which can be technically used was 100% of the undiluted test item. Dilutions were formulated in methyl ethyl ketone.
- Irritation: To determine the highest test item concentration that does not induce local signs of skin irritation or systemic toxicity, a pre-test was performed in two animals. Two mice were treated with test item concentrations of 50% and 100% each on three consecutive days and irritating potential was measured by ear thickness measurements (via micrometer and weighing of punch biopsies). The maximum concentration of test item to be investigated in the LLNA was the dose that could be uniformly applied to the dorsal surface of the ears of the mice and which did at the same time not cause excessive skin irritation or systemic toxicity., i.e. 10, 25 and 50% (w/v).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
Exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
Data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Topical Application:
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear (left and right) with different test item concentrations of 10, 25 and 50% (w/v) in methyl ethyl ketone. The application volume, 25 µl, was spread over the entire dorsal surface (8 mm) of each ear once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the vehicle alone (control animals).
Administration of 3H-Methyl Thymidine:
Five days after the first topical application, all mice were administered with 250 µl of 80.9 µCi/ml 3HTdR (corresponds to 20.2 µCi 3HTdR per mouse) by intravenous injection via a tail vein.
For the determination of lymph node weights, after excision, the lymph nodes were pooled per animal and weighed immediately using an analytical balance.
For the determination of incorporated 3HTdR, lymph nodes were rapidly excised and pooled per group (8 nodes per group), single cell suspensions were prepared by gentle mechanical disaggregation through stainless steel gauze and the level of 3HTdR incorporation was measured on a scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.The ANOVA (Dunnett-test) was conducted on the ear and lymph node weights to assess whether the difference is statistically significant between test item groups and negative control (vehicle) group. However, the primary point of consideration is the biological relevance of the results.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: S.I.: 10% test item: 1.56 25% test item: 2.08 50% test item: 2.39
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM 0 % test item: 2150 10% test item: 3363 25% test item: 4473 50% test item: 5142
Any other information on results incl. tables
Pretest:
Ear swelling was observed on day 6 before sacrifice in the animal treated with 100% test item concentration and the ear thickness measurement on day 6 showed an ear swelling of approximately 28% in comparison to the measurement on day 1 prior to
treatment.
Main test:
No deaths occurred during the study period. No symptoms of local irritation at the ears of the animals and no signs of systemic toxicity were observed during the study period. The body weight of the animals, recordedprior to the first application and prior to treatment with3HTdR, was within the range commonly recorded for animals of this strain and age.
A statistically significant increase in lymph node weights was not observed in any of the test item treated groups in comparison to the vehicle control group. A statistically significant increase in ear weights was not observed in in any of the test item treated groups in comparison to the vehicle control group.
Test item concentration % (w/v) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa |
number of lymph nodes |
DPM per lymph nodeb |
S.I. |
|||
--- |
BG I |
15 |
--- |
--- |
--- |
--- |
--- |
BG II |
20 |
--- |
--- |
--- |
--- |
0 |
1 |
2167 |
2150 |
8 |
268.7 |
|
10 |
2 |
3380 |
3363 |
8 |
420.3 |
1.56 |
25 |
3 |
4490 |
4473 |
8 |
559.1 |
2.08 |
50 |
4 |
5159 |
5142 |
8 |
642.7 |
2.39 |
BG = Background ( 1 mL 5% trichloroacetic acid) in duplicate
1 = Control Group
2 -4 = Test Group
S.I. = Stimulation Index
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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