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EC number: 208-021-9 | CAS number: 505-84-0
- 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
Propylal is not sensitizing in test performed according to OECD TG 406 and GLP.
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:
- From 01 June 2012 to 20 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Adopted 17 July 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed according to M&K was already available.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: Caesarian obtained, Barrier sustained - Virus Antibody Free (COBS - VAF®)
- Age at study initiation:1 to 2 months old
- Weight at study initiation: mean body weight of 293 g (range: 259 g to 517 g)
- Housing: The animals were individually housed in polycarbonate cages with stainless steel lid (Tecniplast 2154, 940 cm²) containing autoclaved sawdust (SICSA, Alfortville, France).
- Diet (e.g. ad libitum): 106 pelleted maintenance diet, batch No. 12010, (SAFE, Augy, France)
- Water (e.g. ad libitum): tap water (filtered with a 0.22 μm filter)
- Acclimation period: at least 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 10 %
- Day(s)/duration:
- On day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol/drinking water treated by reverse osmosis (80/20)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- On day 8 for 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 50 %
- Day(s)/duration:
- On day 22 for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary test: 4 females
Main test :15 females - Details on study design:
- Induction phase - intradermal injections:
On day 1, the dose formulations were administered by intradermal injection in the clipped interscapular region using a sterile plastic syringe fitted with a sterile single use needle.
A constant dosage-volume of 0.1 mL/injection was used.
The dose formulations were stirred continuously throughout the dosing procedure.
Three pairs of injections were given so that one of each pair lies on each side of the midline.
- Freund's Complete Adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl,
- test item in vehicle or vehicle alone,
- test item in FCA/0.9% NaCl (50/50, w/w) or vehicle at 50% (w/v) in FCA/0.9% NaCl (50/50, v/v).
The first and second pairs of injections were given close to each other and nearest the head, while the third pair was given towards the caudal part of the test area.
Induction phase - topical application:
On day 8, a filter paper (approximately 8 cm²) was fully-loaded with the dose formulations, and then applied to the clipped interscapular region, over the intradermal injection sites.
The filter paper was held in place by means of an occlusive dressing for 48 hours.
Control animals received the drinking water treated by reverse osmosis only.
On removal of the dressing, no residual test item was observed.
The presence of local irritation was checked (but not scored).
The induction phase was followed by a 14-day rest period.
Challenge phase:
On day 22, a Finn Chamber® filter paper was fully-loaded with the dose formulations.
The test item dose formulations were applied to the shaved posterior right flank of animals and the vehicle was applied to the shaved posterior left flank.
The chamber was held in contact with the skin by an occlusive dressing for 24 hours.
On removal of the dressing, any residual dose formulation was removed using a cotton pad moistened with drinking water treated by reverse osmosis.
Cutaneous reactions were evaluated before treatment and 24 and 48 hours after removal of the dressing. - Positive control substance(s):
- yes
- Remarks:
- The sensitivity and reliability of the experimental technique used is assessed every 6 months by performing the test with the reference item Benzothiazole-2-thio and checking that at least 30% of responses are positive.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction concentration: intradermal injection day 1 = 0%, cutaneous application day 8 = 0%; Challenge concentration day 22: Left flank = 0%, right flank = 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- IInduction concentration: intradermal injection day 1 = 0%, cutaneous application day 8 = 0%; Challenge concentration day 22: Left flank = 0%, right flank = 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction concentration: intradermal injection day 1 = 10%, cutaneous application day 8 = 100%; Challenge concentration day 22: Left flank = 0%, right flank = 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Discrete erythema (grade 1)
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction concentration: intradermal injection day 1 = 10%, cutaneous application day 8 = 100%; Challenge concentration day 22: Left flank = 0%, right flank = 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test item, Propylal, did not induce delayed contact hypersensitivity in guinea pigs. Therefore, the test item should not be considered as a skin sensitizer.
- Executive summary:
The objective of this study was to evaluate the potential of the test item, Propylal, to induce delayed contact hypersensitivity in guinea pigs.
Methods:
Two preliminary tests were first performed in order to determine the test item concentrations to be used in the main test.
In the main test, one group of ten females received the test item:
- on day 1 by intradermal injections in the interscapular region at the concentration of 10%,
- on day 8 by topical application to the clipped interscapular region at 100%,
- on day 22 by topical application to the posterior right flank at 50%. The posterior left flank of the animals received the vehicle.
Another control group of five females received the vehicles:
- corn oil on day 1 in the interscapular region,
- ethanol/drinking water treated by reverse osmosis on day 8 in the interscapular region,
- acetone on day 22 to the posterior left flank. The posterior right flank of animals received the test item at 50%.
On day 1, three pairs of intradermal injections were performed in the interscapular region of animals:
- Freund's Complete Adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl,
- test item in vehicle or vehicle alone,
- test item in FCA/0.9% NaCl (50/50, w/w) or vehicle at 50% (w/v) in FCA/0.9% NaCl (50/50, v/v).
On day 8, a filter paper (approximately 8 cm²) was fully-loaded with the dosage forms, and then applied to the clipped interscapular region, over the intradermal injection sites. The filter paper was held in place by means of an occlusive dressing for 48 hours. The presence of local irritation was checked (but not scored). The induction phase was followed by a 14-day rest period.
On day 22, a Finn Chamber® filter paper was fully-loaded with the dosage forms. The chamber was held in contact with the skin by an occlusive dressing for 24 hours. Cutaneous reactions were evaluated before treatment and 24 and 48 hours after removal of the dressing. Each animal was observed at least once a day for mortality and clinical signs during the treatment and observation periods. Body weight was recorded on day 1 and at the end of each observation period. On completion of the observation period, the animals were sacrificed then discarded without macroscopic post-mortem examination. No skin samples were preserved.
Results:
After the challenge application, no cutaneous reactions were observed on the left flank (treated with acetone) and on the right flank (treated with the test item) of control animals.
In the test item-treated group, at the 24-hour reading, a discrete erythema (grade 1) was noted at right flank (treated with test item) of only 2/10 animals. In addition, these cutaneous reactions did not persist at the 48-hour reading. Therefore, they were considered not to be attributed to delayed contact hypersensitivity.
Conclusion:
Under the experimental conditions of this study, the test item, Propylal, did not induce delayed contact hypersensitivity in guinea pigs. Therefore, the test item should not be considered as a skin sensitizer.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
- No unscheduled deaths occurred during the main test.
- No clinical signs indicative of systemic toxicity were observed in any animals. Marked local reactions (but no necrosis) at the intradermal injection sites were noted in all animals of both groups from day 6, 7 or 8 until the end of the study period.
- In the control group, at the 24- and 48-hour readings, no cutaneous reactions were observed at left flank (treated with acetone) and at right flank (treated with test item) of animals.
In the test item-treated group, at the 24-hour reading, a discrete erythema (grade 1) was noted at right flank (treated with test item) of only 2/10 animals. In addition, these cutaneous reactions did not persist at the 48-hour reading. Therefore, they were considered not to be attributed to delayed contact hypersensitivity.
- The body weight of the animals was unaffected by the test item-treatment
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
not classified for skin sensitizing hazard based on CLP criteria.
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