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EC number: 412-180-1 | CAS number: 10221-57-5 1,2-DIETHOXYPROPANE; DIETHOXY-1,2-PROPANE
- 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
Skin irritation (in vivo): Not irritating (equivalent or similar to OECD 404/GLP)
Serious eye damage/eye irritation (in vivo): Not irritating (equivalent or similar to OECD 405/GLP)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17th August 1991 - 2nd Decmber 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: 9059
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test material, a colourless liquid, was stored in the dark under ambient conditions. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon
- Age at study initiation: young adult
- Housing: The rabbits were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays.
- Diet: Standard Rabbit Diet, supplied by Special Diets
Services, 1 Stepfield, Witham, Essex, CM8 3AD ad libitum
- Water: tap water ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20 °C
- Humidity (%): 57%
- Photoperiod (hrs dark / hrs light): A 12 h light/dark cycle was in operation - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Ethylene glycol diethyl ether (ethyl glyme),
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL
- Concentration (if solution):undiluted
0.5mL of the control material, ethylene glycol diethyl ether (ethyl glyme) was also applied. - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 1, 24, 48 and 72 h after patch removal. Further assessments were carried out at 5, 6, 8, 9, 10 and 11 days after patch removal to determine the reversibility of responses.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: The hair was clipped from the dorsal area of the trunk of each rabbit approximately 24 h before treatment. Care was taken to avoid abrading the skin.
- % coverage: The test and control materials (0.5 ml) were applied to intact skin on each rabbit under 2.5 cm x 2.5 cm patches of gauze.
- Type of wrap if used: Due to the volatility of the test material, the patches were covered with Sleek, an occlusive dressing, which remained in position for 4 h.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The patches were removed and the skin wiped with water dampened tissues to remove surplus test material without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: After 4 hr exposure period
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1, 24, 48 and 72 h after patch removal. Further assessments were carried out at 5, 6, 8, 9, 10 and 11 days after patch removal to determine the reversibility of responses.
SCORING SYSTEM:
- Method of calculation: The daily scores for erythema and oedema for the test and control material at the 24, 48 and 72 h assessments were totalled and the mean was calculated. This mean value is expressed as a mean irritation score for each material. The Draize scoring system was used (Appendix). - Irritation parameter:
- erythema score
- Basis:
- other: animals 1 & 2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- other: animals 1 & 2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- other: animals 1 & 2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 11 days
- Remarks:
- Erythema = 1
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 11 days/Erythema = 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- overall irritation score
- Remarks:
- erythema
- Basis:
- animal: 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 11 days
- Remarks:
- Animal #3 erythema = 1
- Irritation parameter:
- overall irritation score
- Remarks:
- oedema
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- overall irritation score
- Remarks:
- oedema
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- overall irritation score
- Remarks:
- oedema
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Following a 4 h application of both the test and control materials, very slight to well defined erythema and very slight to slight oedema were noted up to 72 h after patch removal. At 5 days skin reactions deteriorated at a test site treated with test material and a test site treated with control material on one rabbit.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo skin irritation study in male New Zealand rabbits, the substance 1,2-Diethoxypropane was not irritating.
- Executive summary:
In a primary dermal irritation study (8280), 3 male rabbits were dermally exposed (dorsal area of the trunk; occlusive) to 0.5mL of undiluted 1,2-Diethoxypropane for 4 hours. The substance was removed after 4 hrs with washing. Animals were observed at 24, 48 and 72 hrs for overall irritation scores and up to 11 days for reversibility. Irritation was scored by the method of Draize.
The overall irritation score (erythema) for all animals was 1.33. In only 1 animal (#3) the irritation was not fully reversible at Day 11 (erythema = 1). The overall irritation score (oedema) for animal #1 was 0. The overall irritation score (oedema) for animal #2 was 1.33 (fully reversible within 10 days). The overall irritation score (oedema) for animal #3 was 0.66 (fully reversible within 8 days). The observations were not extended to 14 days. In only 1 animal (#3) was the erythema not fully reversible at Day 11 (erythema = 1). Overall, based on the CLP criteria, the substance is not irritating.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19th August 1991 - 2nd December 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: 9059
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test material, a colourless liquid, was stored in the dark under ambient conditions. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon
- Age at study initiation: young adult
- Housing: The rabbits were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays.
- Diet: Standard Rabbit Diet, supplied by Special DietsServices, 1 Stepfield, Witham, Essex, CM8 3AD ad libitum
- Water: tap water ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 60%
- Photoperiod (hrs dark / hrs light): A 12 h light/dark cycle was in operation - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 mL - Duration of treatment / exposure:
- The eye was not washed after treatment.
- Observation period (in vivo):
- 1, 24, 48 and 72 h after instillation.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Approximately 24 h before test commencement; both eyes of the rabbits were examined and only animals with no ocular defects were used in the test.The rabbit was held firmly but gently and the test material placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for one or 2 s. One rabbit was treated first and observed 1 h after instillation for signs of severe irritation. As none were noted, the remaining 2 rabbits were then treated the following day.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: The OECD Recommended Scoring System in OECD 405 was used.
TOOL USED TO ASSESS SCORE: The eyes were examined for irritation, using a hand held magnifier and pen torch (Pifco) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2,3
- Time point:
- other: 48/72 hrs
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Details of reaction scores are given in the Table. No corneal or iridial responses were noted. Slight conjunctival redness and chemosis and a slight discharge were noted up to 24 h post instillation. Full recovery was noted in all treated eyes at 48 h post instillation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo eye irritation study in New Zealand rabbits, the substance 1,2-Diethoxypropane is not irritating.
- Executive summary:
In a primary eye irritation study (8281), 0.1mL of 1,2-Diethoxypropane (undiluted) was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits (3 males). The eye was not washed after instillation of the test article. Animals were observed for 1 hr, 24 hr, 48 hr and 72 hrs after dosing. Irritation was scored by the method of Draize.
The following mean values, based on the results from the 24, 48 and 72 hour readings were calculated - cornea opacity: 0; iris lesion: 0; oedema of conjunctiva (chemosis): 0; redness of conjunctiva: 0.33 (fully revsersible).
In this study, 1,2-Diethoxypropane is not an eye irritant.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
There is no in vitro skin irritation test available for 1,2-Diethoxypropane. There is one in vivo skin irritation test in rabbits available.
In a primary dermal irritation study (equivalent or similar to OECD 404/GLP), 3 male rabbits were dermally exposed (dorsal area of the trunk; occlusive) to 0.5mL of undiluted 1,2-Diethoxypropane for 4 hours. The substance was removed after 4 hrs with washing. Animals were observed at 24, 48 and 72 hrs for overall irritation scores and up to 11 days for reversibility. Irritation was scored by the method of Draize. The overall irritation score (erythema) for all animals was 1.33. In only 1 animal (#3) the irritation was not fully reversible at Day 11 (erythema = 1). The overall irritation score (oedema) for animal #1 was 0. The overall irritation score (oedema) for animal #2 was 1.33 (fully reversible within 10 days). The overall irritation score (oedema) for animal #3 was 0.66 (fully reversible within 8 days). The observations were not extended to 14 days. In only 1 animal (#3) was the erythema not fully reversible at Day 11 (erythema = 1). Overall, based on the CLP criteria, the substance is not irritating.
Serious eye damage/eye irritation:
There is no in vitro eye irritation test available for 1,2-Diethoxypropane. There is an in vivo eye irritation study in rabbits available.
In a primary eye irritation study (equivalent or similar to OECD
405/GLP), 0.1mL of 1,2-Diethoxypropane (undiluted) was instilled into
the conjunctival sac of the right eye of young adult New Zealand White
rabbits (3 males). The eye was not washed after instillation of the test
article. Animals were observed for 1 hr, 24 hr, 48 hr and 72 hrs after
dosing. Irritation was scored by the method of Draize. The following
mean values, based on the results from the 24, 48 and 72 hour readings
were calculated - cornea opacity: 0; iris lesion: 0; oedema of
conjunctiva (chemosis): 0; redness of conjunctiva: 0.33 (fully
revsersible). In this study, 1,2-Diethoxypropane is not an eye irritant.
These studies are suitable to use the in human health assessment.
Justification for classification or non-classification
Based on the available information in the dossier, the substance 1,2 Diethoxypropane (CAS No. 10221-57-5) is not classified for skin irritation/corrosion or serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.
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