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Diss Factsheets
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EC number: 202-784-1 | CAS number: 99-75-2
- 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
![](https://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
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Methyl p-toluate
- EC Number:
- 202-784-1
- EC Name:
- Methyl p-toluate
- Cas Number:
- 99-75-2
- Molecular formula:
- C9H10O2
- IUPAC Name:
- methyl 4-methylbenzoate
- Details on test material:
- purity: 97.8%
expiry date: 2015-10-15
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 15.86 g - 20.92 g
- Housing: individually, in solid floor standard polysulfone cages (Size: Approximately L 360 x B 205 x H 140 mm)
- Diet: Ssniff mice pellet food – Ssniff Spezialdiäten GmbH., Ferdinand-Gabriel-Weg 16, D-59494 Soest, Germany (ad libitum)
- Water: deep bore-well water passed through activated charcoal filter and exposed to UV rays (ad libitum)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 64 - 65
- Air changes (per hr): 13.4
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0, 10, 25, 75 %
- No. of animals per dose:
- 6
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- 25% α – Hexylcinnamaldehyde (HCA) in DMF SI = 7.43+-1.15
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see above
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Group and Dose concentration No. of mice DPM/Mouse SI G1 vehicle DMF 6 554+-90 1.00+-0.26 G2 25% HCA in DMF 6 4116+-640 7.43+-1.15 G3 10% substance in DMF 6 1096+-166 1.98+-0.30 G4 25% substance in DMF 6 2180+-562 3.93+-1.01 G5 75% substance in DMF 6 3023+-521 5.45+-0.94
Any other information on results incl. tables
EC3calculation:
EC3 = XL+ [(3-YL)/ (Yh-YL)](Xh-XL)
Where, YL = SI value below 3
XL = chemical concentration that elicits YL
Yh = SI value above 3
Xh = chemical concentration that elicits Yh
EC3 value for the substance is 17.85%
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item demonstrated skin sensitization potential in the mouse LLNA, as the lymph nodes draining the area of topical application elicit a proliferative response greater than the threshold (SI ≥ 3, i.e. 3-fold greater proliferation than vehicle control).
- Executive summary:
The substance was tested for skin sensitisation according to OECD guideline 429 (Local lymph node assay, LLNA) in DMF.
In a sceening study the vehicle- N,N-dimethylformamide (DMF), 5, 10, 25, 50 and 75% w/v of the substance in DMF were applied to one animal at each dose level for 3 days. There were no clinical signs, no erythema at the site of application, no significant increase in the ear thickness and ear punch weights and no effect on body weight.
In the LLNA main study six female CBA/Ca mice/group received the vehicle (DMF) or 25% α-hexylcinnamaldehyde (HCA: positive control in DMF) or 10, 25 and 75%w/v test item in DMF on days 1 to 3. On day 6, uptake of3H-methyl thymidine into the auricular lymph nodes draining the site of test item application was measured approximately five hours post administration. Proper conduct of the LLNA was confirmed via a positive response using 25% α-hexylcinnamaldehyde, a contact sensitizer, which elicited proliferation with a Mean Stimulation Index (SI) value of 7.43, in comparison to vehicle-treated mice.
There were no clinical signs, no local skin reactions,no significant increase in % ear thickness and ear punch weight at the tested concentrations and treatment had no significant effect on body weight gain.
The test item at dose concentrations of 10, 25 and 75% w/v elicited proliferative response with SI of 1.98, 3.93 and 5.45, respectively in comparison with the vehicle-treated mice. The EC3value was 17.85%.
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.
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