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Diss Factsheets
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EC number: 203-539-1 | CAS number: 107-98-2
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study methodology followed was equivalent or similar to EU Method B.6 and was conducted in accordance with the Principles of GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Porcellus Ltd.
- Age at study initiation: not specified in the report
- Weight at study initiation: 505-612 g
- Housing: 2-3 animals/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): not specified in the report
- Air changes (per hr): not specified in the report
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle - Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml of undiluted methyl proxitol
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml of undiluted methyl proxitol
- No. of animals per dose:
- Test group - 10 males + 10 females
Control group - 5 males + 5 females - Details on study design:
- RANGE FINDING TESTS: The purpose of the range finding studies was to determine the concentrations of methyl proxitol to be used for intradermal injections, topical induction and topical challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: total of 4 intradermal injections (2 injections - 0.1 ml in corn oil and 2 injections - 0.1 ml in 50:50 FCA/corn oil), after one week of the intradermal injection, topical application for 48 hours
- Exposure period: same as above
- Test groups: one
- Control group: one
- Site: the animals were closely shorn in the shoulder region using electric clippers followed by an electric razor, two rows of three injections were made, one on each side of the midline
- Frequency of applications: one topical application
- Duration: 48 hours
- Concentrations: 0.3 ml of methyl proxitol
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: two weeks after topical induction
- Exposure period: 24 hours
- Test groups: one
- Control group: one
- Site: on the flank
- Concentrations: 0.1 ml of undiluted methyl proxitol
- Evaluation (hr after challenge): immediately after patch removal, 24 and 48 hours after patch removal - Challenge controls:
- not applicable
- Positive control substance(s):
- no
- Statistics:
- The result of the test was expressed as the numbers of positive responses shown by the test animals at both 24 and 48 hours after the removal of the challenge patches. The frequency of positive responses rather than their intensity was regarded for statistical purposes.
- Positive control results:
- not applicable
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of the study, methyl proxitol is not a skin sensitizer.
- Executive summary:
Skin sensitization study of methyl proxitol was conducted in groups of guinea-pigs (test group - 10 males + 10 females, negative control group - 5 male + 5 female) at the following concentrations - intradermal induction (0.1% m/v in corn oil), topical induction (undiluted) and topical challenge (undiluted). None of the 20 test animals showed any positive response at either 24 and 48 hours after removal of the challenge patches. Based on the results of the study, methyl proxitol was not concluded as a skin sensitizer in guinea-pigs
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No sensitization reactions were observed with propylene glycol methyl ether in both the studies. In both the Maximization test (0/20) and the modified Maguire test (0/10) the sensitization rate was 0% for the undiluted material.
Migrated from Short description of key information:
A guinea pig maximization test conducted according to GLP and a non-GLP study according to a modified Maguire protocol are available for propylene glycol methyl ether.
Justification for selection of skin sensitisation endpoint:
The study methodology followed was equivalent or similar to EU Method B.6 and was conducted in accordance with the Principles of GLP
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the absence of skin sensitising potential, genotoxicity and irritancy, propylene glycol methyl ether is not expected to be a respiratory tract sensitiser.
Migrated from Short description of key information:
No studies on respiratory sensitization are available for propylene glycol methyl ether but an assessment of sensitising potential is made using the skin sensitisation and genotoxicity data.
Justification for classification or non-classification
No sensitization reaction was observed with propylene glycol methyl ether. In both the Maximization test (0/20) and the modified Maguire test (0/10) the sensitization rate was 0% for the undiluted material.
According to EU criteria for classification and labelling requirements for dangerous substances as laid down in Annex VI of the EEC Council Directive 67/548 EEC (amended by Directive 83/467 EEC), PROPYLENE GLYCOL METHYL ETHER is not classified as a skin sensitiser.
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