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EC number: 247-045-4 | CAS number: 25498-49-1
- 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-studies according to EPA/OPP guidelines for skin and eye irritation are available for tripropylene glycol methyl ether. These are supported by 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:
- weight of evidence
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted prior to GLP and guidelines. The report contains sufficient amount of data for the interpretation of the results. Non-GLP studyequivalent to OECD guideline 404. Quality Check: This study was performed prior to establishment of GLPs or publication of protocol guidelines. The report included very limited documentation for methods and results but the performing institution, Carnegie Mellon, was/is highly regarded. As typical for a study this old, the report did not provide sufficient documentation that elements of OECD Protocol 404: "Acute Dermal Irritation/Corrosion" were followed, although the numbers and type of test animals used (but not their husbandry conditions) were as recommended in the guidance. Remarkably, the length of time that test material was held in contact with the skin was not defined. Test material characterization was not addressed other than to identify batch numbers, amount received, and receipt dates. While the length of the observation period was not explicitly stated it is presumed to have been the typical 14 days or until all signs of irritation had regressed; the toxicity endpoints monitored were typical for this type assay and adequately recorded.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- open
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.010ml
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 5
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours to 14 days
- Score:
- 1
- Max. score:
- 10
- Reversibility:
- other: no irritation effects observed
- Irritant / corrosive response data:
- no injury is judged to be a grade 1.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Tripropylene glycol methyl ether (TPM) does not appear to be irritating to the skin of rabbits under the conditions of this test.
Classification: not irritating - Executive summary:
Tripropylene glycol methyl ether (TPM) was tested for skin irritation in albino rabbits. 3 to 5 old male rabbits were used. TPM was applied to the intact clipped skin of the belly of 5 albino rabbits for an unspecified period of time. The application site was not covered and, presumably, subjects were restrained to prevent grooming and consequent ingestion (subjects were restrained in the dermal LD50 test by the same institution, described above, on this same batch of test material). Irritation was scored on a scale of 1 to 10, based on moderate or marked capillary injection, erythema, edema or necrosis within 24 hours. While the length of the observation period was not explicitly stated it is presumed to have been the typical 14 days or until all signs of irritation had regressed; the toxicity endpoints monitored were typical for this type assay and adequately recorded. No evident injury is judged to be a Grade 1.
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:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to EPA/OPP guideline and in accordance with GLP
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Principles of method if other than guideline:
- Guideline study
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Clerco Research Farm, Cincinnati, OH.
- Age at study initiation: Young adult
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 67±5 Deg. F
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): One-tenth (0.1) millitier/eye - Duration of treatment / exposure:
- 0.1 ml of material was placed in the right eye .
The treated eyes of 6 rabbits were unwashed.
The treated eyes of 3 rabbits were washed for 1 minute with lukewarm tap water at a rate of approximately 1 liter per minute beginning approximately 30 seconds after installation of the test article. - Observation period (in vivo):
- 1, 24, and 48 hours and 72 hours.
- Number of animals or in vitro replicates:
- Unwashed eye group-6 animals
Washed eye group- 3 animals - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : The treated eyes of 3 rabbits were washed for 1 minute with lukewarm tap water at a rate of approximately 1 liter per minute beginning approximately 30 seconds after installation of the test article.
- Time after start of exposure: The right eye of each animal was examined for ocular irritation and lesions at 1 hour
(± 15 minutes), and at 24, 48, and 72 hours (± 2 hours at each interval).
SCORING SYSTEM: Draize Score
TOOL USED TO ASSESS SCORE: A pocket flashlight without magnification was used at all evaluation intervals, and a 2% sodium fluorescein solution in deionized water was used at all evaluations except for those done at 1 hour after instillation. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: unwashed eye group
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: washed eye group
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: unwashed eye group
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: washed eye group
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: unwashed eye group
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: washed eye group
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.6
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: unwashed eye group
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: washed eye group
- Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the annex VI of the council directive 67/548 EEC (amended by directive 83/467 EEC) the average scores over all animals for cornea opacity, iris lesions, conjunctivae and chemosis were 0, 0, 0.4 and 0.6, respectively at 24, 48 and 72 hours. According to EEC criteria no classification for eye irritancy is required.
- Executive summary:
The test article, A273956, was evaluated for primary eye irritation after instillation in the right eyes of 9 rabbits.
This study was designed to comply with the procedure described in EPA/OPP Guidelines, 1982.
The eyes of 3 of these 9 rabbits were washed with lukewarm tap water after instillation. The treated eyes of all animals (washed and Unwashed) were evaluated at 1, 24, 48, and 72 hours after installation.
No mortalities or abnormal clinical signs were observed during the study. Blistering of the conjunctivae was noted for all the unwashed and washed group animals at the one hour evaluation, which was fully reversible before 72 hours.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two skin irritation studies are available for tripropylene glycol methyl ether. Both studies are considered to be reliable with restrictions (Klimisch 2). In the identified key study (Dow, 1977) with unoccluded dermal application of tripropylene glycol methyl ether to rabbits produced no irritation, the overall mean irritation score (24 hours to 14 days) was 1 out of a maximum score of 10.
In the second key study (Lyondell, 1984), using impermeable occlusion for 24 hours, skin irritation was observed. All effects were reversible within 14 days. This study using impermeable occlusion is likely overestimating the irritancy of the test material and current guidelines are recommending semi-occlusive dressing. Therefore, on the basis of the earlier Dow, 1977 study, tripropylene glycol methyl ether is not considered to be a skin irritant under standard conditions.
Overall, three eye irritation studies are available for tripropylene glycol methyl ether. In the identified key study (Arco, 1984), only slight and fully reversible effects were observed after administration of tripropylene glycol methyl ether to rabbits eyes. The mean corneal and iris scores (for 6 rabbits) was 0 across 24, 48 and 72 hours in both the washed and unwashed eyes. The mean conjunctival scores were 0.4 (unwashed eye group) and 0.3 (washed eye group), while the mean chemosis scores were 0.6 (unwashed eye group) and 0.3 (washed eye group), respectively. There were no cumulative effects and these effects were fully reversible within 48 -72 hours. In the supporting study (Dow, 1977 and Dow, 1953), fluorescein staining revealed no corneal injury.
Justification for selection of skin irritation / corrosion endpoint:
Although the study was conducted prior to GLP and guidelines, the report contains sufficient information to permit a meaningful evaluation of study results.
Justification for selection of eye irritation endpoint:
The study was conducted according to EPA/OPP guideline and in accordance with GLP.
Justification for classification or non-classification
Based on EU criteria, no classification for skin and eye irritation is required for tripropylene glycol methyl ether.
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 for cornea opacity, iris lesions, conjunctivae and chemosis were 0, 0, 0.4 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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