Registration Dossier
Registration Dossier
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EC number: 216-374-5 | CAS number: 1569-02-4
- 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 sensitisation
Administrative data
- 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:
- comparable to guideline study
- Remarks:
- The study methodology followed was equivalent or similar to EU Method B.6 and was conducted in accordance with the Principles of GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing reliable GPMT study already available.
Test material
- Reference substance name:
- 1-methoxypropan-2-ol
- EC Number:
- 203-539-1
- EC Name:
- 1-methoxypropan-2-ol
- Cas Number:
- 107-98-2
- IUPAC Name:
- 1-methoxypropan-2-ol
- Reference substance name:
- 1-methoxypropano-2-ol
- IUPAC Name:
- 1-methoxypropano-2-ol
- Details on test material:
- 1-methoxypropan-2-ol is a close structural analogue of 1-ethoxypropan-2-ol, which is the major hydrolysis product of the submission substance (2-ethoxy-1-methyl ether acetate). Details for the surrogate material:
- Analytical purity: Analysed purity 99% .
- Supplied by Merck, manufacturer’s quoted purity >99%
- Impurities: peroxides 0.5-2mg/l.
A detailed justification for read across within the P series glycol ethers is attached to chapter 13 of the IUCLID dossier for this substance.
Constituent 1
Constituent 2
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml of undiluted methyl proxitol
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml of undiluted methyl proxitol
- Adequacy of challenge:
- not specified
- 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
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- 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.
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