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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
GLP guideline studies for skin- and eye- irritation are available for propylene glycol methyl ether. These studies are supported by several non-GLP studies equivalent or similar to OECD guidelines 404 and 405.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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.4 and was conducted in accordance with the Principles of GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in-house
- Age at study initiation: 4-9 months
- Weight at study initiation: 4529-4920 g
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 °C
- Humidity (%): not specified in the report
- Air changes (per hr): not specified in the report
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observations were made at 30 minutes after patch removal and 24, 48, 72 hours and 7 days after application
- Number of animals:
- 3 male + 3 female
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area between the shoulders and hindquaters
- Type of wrap if used: ealstic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: approximately 4 hours post-exposure
SCORING SYSTEM: Draize method - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: male
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: male
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: male
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: female
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: female
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: female
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: males and females
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: male
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: male
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: female
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: female
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: male
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: female
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: males and females
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hour scores
- Score:
- 0
- Irritant / corrosive response data:
- No skin reactions were observed from the application of undiluted methyl proxitol to rabbit skin, consequently the group mean 24, 48 and 72 hours scores for erythema and oedema were zero
- Other effects:
- not applicable
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, methyl proxitol was concluded as not irritating to semi-occluded rabbit skin. Mean scores for erythema and edema were 0 for all animals.
- Executive summary:
Skin irritation study of Methyl proxitol was evaluated in rabbits (3 males + 3 females) and no skin were observed from the application of undiluted methyl proxitol to rabbit skin, consequently the group mean 24, 48 and 72 hours scores for erythema and oedema were zero. Based on the results of the study, methyl proxitol was concluded as not irritating to semi-occluded rabbit skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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.5 and was conducted in accordance with the Principles of GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: in-house
- Age at study initiation: 4-9 months
- Weight at study initiation: 4785-4956 g
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 °C
- Humidity (%): not specified in the report
- Air changes (per hr): not specified in the report
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml of undiluted methyl proxitol
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 male + 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 1, 24, 48, 72 hours and 7 days post-exposure
SCORING SYSTEM: Draize scoring method and Kay and Calandra
TOOL USED TO ASSESS SCORE: visual assessment of eye irritancy was made. In the event of any corneal damage, visualization was aided by the instillation of one drop of 2% fluorescein solution - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Conjunctival redness, chemosis and discharge, corneal opacity and damage to the iris were assessed and the scores at 1 hour, 24, 48 and 72 hours and 7 days were calculated. Refer to table 1 for further details
- Other effects:
- The instillation of undiluted methyl proxitol into the conjunctival sac of one eye of each of the six rabbits resulted in severe initial pain
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, Methyl proxitol was classifed as not irritating to rabbit eye according to EU criteria.
- Executive summary:
The instillation of undiluted Methyl proxitol into the conjunctival sac of one eye of each of six rabbits resulted in severe initial pain. The conjunctival redness, chemosis and discharge, corneal opacity and damage to the iris were assessed and the scores at 1 hour, 24, 48 and 72 hours and 7 days were calculated. One rabbit showed transient corneal opacity.
On the basis of the modified Kay and Calandra grading scheme, methyl proxitol was classifed as mildly irritating to rabbit eyes. The group mean 24, 48 and 72 hour scores for redness, chemosis, corneal opacity and iritic effects were 1.5, 0.6, 0.1 and 0, respectively. On the basis of these scores, methyl proxitol was not classified as irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Several skin and eye irritation studies conducted according to the OECD guidelines or equivalent methodologies are available. All studies demonstrate that propylene glycol methyl ether is not an irritant to the skin or eyes.
No data on respiratory irritation is available and given the absence of skin and eye irritation it is concluded that this substance will not have a potential for respiratory irritation.
Justification for selection of skin irritation / corrosion endpoint:
The study methodology followed was equivalent or similar to EU Method B.4 and was conducted in accordance with the Principles of GLP.
Justification for selection of eye irritation endpoint:
The study methodology followed was equivalent or similar to EU Method B.5 and was conducted in accordance with the Principles of GLP
Justification for classification or non-classification
Skin irritation: according to EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) the mean value for erythema and edema scores was 0 for all animals at any time. According to annex VI of the directive propylene glycol methyl ether is not classified as skin irritant.
Eye irritation: according to the annex VI of the council directive 67/548 EEC (amended by directive 83/467 EEC) the average scores over all animals
cornea opacity, iris lesions, conjunctivae and chemosis were 0.1, 0, 1.5 and 0.6, respectively at 24, 48 and 72 hours. According to EEC criteria no classification for eye irritancy is required.
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